Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Xerostomia

Deglutition Disorders

Mucositis

Vickie Baracos, MD

The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

Head and neck cancer patients often have difficulty meeting their nutritional needs while undergoing radiation therapy (RT) and/or chemotherapy (RTchemo). Tumor locations and side effects of RT or RTchemo, including dry mouth, mouth sores, difficulty chewing and swallowing, changes in taste and smell, and loss of appetite, lead to poor food intake and weight loss. The investigators hope to learn more about how side-effects of RT or RTchemo affect food intake and nutrition status.

Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients

Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients Prior to, on Completion of and Six Weeks After Oncology Treatment

Cross Cancer Institute

AHS Cancer Control Alberta

TKI258

Novartis Pharmaceuticals

This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.

Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors

A Randomized, Open-label, Multi-center, Phase I, Crossover Study to Assess the Relative Bioavailability of 2 Oral Formulations of TKI258 (CSF Capsule vs. FMI Tablet), and the Effect of Food on the Bioavailability of TKI258, in Patients With Advanced Solid Tumors

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Esomeprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Intervention A: BAY2927088 is administered under fasted status. Intervention B: BAY2927088 is administered under fed status (light low-fat meal).

Intervention C: BAY2927088 is administered under fed status (high fat, high calorie meal).

Each participant will subsequently undergo a fourth intervention period that includes dosing with BAY2927088 and esomeprazole.

BAY2927088

light low-fat meal or high fat, high calorie meal

Food

Bayer Clinical Trials Contact

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations.

Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.

In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.

BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.

The absorption of BAY2927088 into the blood is dependent on the amount of acid present in the stomach. Esomeprazole is a medicine which is used in the treatment of heartburn and excessive acid in the stomach. Both food and esomeprazole may change the amount of acid present in the stomach.

The main purpose of this study is to find out how food and esomeprazole may affect the absorption of BAY2927088 into the blood of healthy participants. For this, researchers will measure the levels of BAY2927088 in participants' blood when it is given with or without food as well as with or without esomeprazole. Researchers will then calculate the following:

* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood

The study will have 4 treatment periods:

- Periods 1 to 3 (Day 1 to Day 9): All participants will take BAY2927088 with a low-fat meal, with a high-fat meal, and on an empty stomach, but in a different order, over the 3 study periods. Each period will last for 3 days and BAY2927088 will be given on the first day of each period.

On Day 9, participants will take esomeprazole on an empty stomach.

- Period 4 (Day 10 to Day 14): On Days 10 and 11, participants will take esomeprazole on an empty stomach. On Day 12, participants will take esomeprazole on an empty stomach. After 1 and a half hours, participants will take low-fat meal and BAY2927088.

On Day 13, participants will take esomeprazole on an empty stomach.

Participants will be in this study for about 8 weeks with 3 visits to the study clinic.

Participants will visit the study clinic:

* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study
* once on the day before the treatment starts and will stay in the clinic until Day 14 of the treatment
* once, 7 to 10 days after last dose of BAY2927088, for a health check-up

During the study, the doctors and their study team will:

* do physical examinations
* collect blood samples from the participants to measure the levels of BAY2927088
* check participants' health by performing tests, such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective of whether they think it is related or not to the study treatment.

A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants

A Phase 1, Open Label, Randomized, Crossover Study to Investigate the Effect of Food and Effect of an Acid Reducing Agent on the Pharmacokinetics of BAY 2927088 in Healthy Participants

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Bayer

Symptoms and General Pathology

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Nervous System Diseases

Immune System Diseases

Infections

Rare Diseases

Crohn Disease

Colitis

Colitis, Ulcerative

Intestinal Diseases

Inflammatory Bowel Diseases

Ulcer

Arthritis

Arthritis, Psoriatic

Sclerosis

Psoriasis

Multiple Sclerosis

Autoimmune Diseases

Arthritis, Rheumatoid

Spondylarthropathies

Joint Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Skin Diseases

Skin Diseases, Papulosquamous

Gastroenteritis

Gastrointestinal Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Spondylitis

Spondylarthritis

Spinal Diseases

Bone Diseases

Chronic Graft Versus Host Disease

Spondylarthropathy

Participants from the "Diet, Cancer and Health" (DCH) cohort with no CID diagnosis at entry to the DCH study. The number of persons developing a CID (defined as at least one of the mentioned CIDs) during follow up (1993/1997 - 2018) and the number of persons not developing a CID will be investigated.

Based on the participants reporting of dietary habits in the Food Frequency Questionnaire (FFQ) from the DCH study, the exposure "intake of red and processed meat and fibres" will be investigated in both CID cases and non-cases.

Other exposure variables are "Lifestyle factors independently or combined" and are also obtained from the data in the DCH cohort.

The intention is to analyse exposure groups in tertiles: 1) Upper tertile (33.3% of the total sample) based on the ratio: meat/fibre intake is associated with higher risk of CID. 2) Low intake of fibre (defined as below the lower tertile \[33.3% of the total sample\]) and high intake of red and processed meat (defined as those above the upper tertile \[33.3% of the total sample\]) are independently associated with higher risk of CID, and their synergy (interaction between the factors meat and fibres) gives the highest risk outcome.

Intake of red and processed meat and fibres

Lifestyles factors are defined as: red and processed meat, vegetables, dietary fibre, cereals, gluten, legumes, red wine, dairy products, physical activity, smoking, total protein/fat, protein/fat from red and processed meat, glycemic index.

Lifestyle factors independently or combined

Vibeke Andersen, Prof

Chronic inflammatory diseases (CID) - including inflammatory bowel diseases (Crohn's disease and ulcerative colitis), rheumatic conditions (rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis), inflammatory skin diseases (psoriasis) and multiple sclerosis are diseases of the immune system that have some shared genetic and environmental predisposing factors, but still little is known on the effects of lifestyle as a prognostic factor on disease risk. This observational study will contribute to preexisting research on lifestyle factors by identifying diet factors associated with risk of developing CID, using prospective register data.

The study will use data from all of the 57,053 participants in the Danish cohort "Diet, Health and Cancer (DHC)" together with registry data. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at the DHC study entry. The National Patient Registry (NPR) will be used to obtain to identify patients with CID during follow-up. Follow-up information on death and immigration will be collected in March 2018 from the Danish Civil Registration Register.

The outcome CID is defined as at least one of the following CIDs: Crohn's disease, ulcerative colitis, psoriasis/psoriatic arthritis, rheumatoid arthritis/ankylosing arthritis, or multiple sclerosis, during the follow-up period from 1993 to March 2018.

The primary hypothesis is that "the risk of CID will be significantly higher among those with a low fibre/high red and processed meat intake compared to those with a high fibre/low red and processed meat intake." Based on previous research on a shared etiology in CIDs a second hypothesis is that "the postulated causality between low fibre/high red and processed meat intake and risk of developing CID is applicable for each of the CID-diagnoses."

The core study is an open register-based cohort study. The study does not need approval from the local Ethics committee or Institutional Review Board by Danish law. The study was approved by the Danish Data Protection Agency (2012-58-0018) Study findings will be disseminated through peer-reviewed journals, patient associations and presentations at international conferences.

Material and methods:

The study design is a cohort study with prospective register data follow up. The Danish cohort "Diet, Health and Cancer" (DHC) will be used. The DHC Study is an ongoing Danish cohort study designed to investigate the relation between diet, lifestyle and disease risk. The cohort consists of 57,053 persons, recruited between December 1993 and May 1997. All the subjects (50 to 64 years of age) gave detailed information on diet (food frequency questionnaire) and other lifestyle data together with biological samples. Blood samples, anthropometric measures and questionnaire data on diet and lifestyle were collected at study entry. Data from the DHC cohort will be combined with Danish national registers (the National Patient Registry (NPR), the Danish Civil Registration Register, and The Danish National Prescription Registry).

Outcome measures and follow-up: The National Patient Registry (NPR) will be used to obtain to identify patients with CID during follow-up. The NPR contains data on all patients admitted to Danish hospitals since 1977. The register covers both inpatient and outpatient records and indicates the main medical reason for diagnostic procedures or treatment (since 1994 according to the tenth version of the International Classification of Diseases (ICD-10)). For this study there will be extracted data from NPR from 1993 to March 2018. The outcome CID is defined as at least one of the following diseases in the NPR; inflammatory bowel disease (IBD) (ICD10 codes: K50-K51), psoriasis/psoriatic arthritis (ICD10 codes: M073, M090, L40), rheumatoid arthritis/ankylosing arthritis (ICD10 codes: M059. M060, M069, M089, M459, M46), or multiple sclerosis (ICD10 codes: G35, G35.9), during the follow-up period. The Danish National Prescription Registry will be used to identify the most severe cases of the following diseases listed above, as it is expected that the patients have medication in relation to the diseases. Follow-up information on death and immigration will be collected in March 2018 from the Danish Civil Registration Register.

Exposure and possible confounders: Information on exposure is defined as high fibre intake and high red and processed meat intake and were collected at enrolment of the DHC cohort using questionnaires and interviews. In short, the food-frequency questionnaire, diet consumption was assessed in 12 categories of predefined responses, ranking from "never" to "eight times or more per day". The daily intake was then calculated by the software program FoodCalc. FoodCalc is a simple program to calculate intake of nutrients when given a list with amounts of different foods consumed and another list with contents of nutrients for the different foods. Both intake of dietary fibre and red meat and processed meat were measured as continues variable in g/day. Information on possible confounders will also be obtained from the questionnaire data at enrolment in relation to sex, age, BMI, smoking and other lifestyle factors and information on co-morbidity will be obtained from NPR.

Statistical analyses: The intention is to use data obtained from this prospective cohort study to explore the ability to predict risk of CID (Y=primary endpoint) and to explore whether diets low in fibre AND high in red and processed meat (X=assessed at baseline) are an informative prognostic factor on disease risk. Descriptive analyses for categorical variables will be presented as frequencies, and differences between CID cases and non-cases will be evaluated by Chi-square test. Continuous variables will be tabulated as medians (with quartiles, Q1 and Q3) and nonparametric tests on the equality of medians will be used to test for differences between groups. P-values below 0.05 will be considered statistically significant. Negative binomial regression will be applied to calculate incidence rates per 1000 patient years and incidence rate ratios (IRR) between exposures. To investigate the risk of and time to CID-diagnosis the Fine-Gray competing risk regression model will be applied, and thus competing risk of death will be taken into account while handling emigration as censoring, and reporting cumulative incidences and sub-hazard ratios (SHR) and the corresponding p-values for CID associated with specified food substitutions. Regressions will be carried out as both crude regression, only including the exposure, and adjusted for age, sex, lifestyle factors and selected comorbidities. Analyses will be conducted using Stata.

To test if the hypothesized causality between diet factors and development of CID is applicable for all of the CIDs there will be conducted subanalyses on each of the CID-diagnoses. Sensitivity analyses will be conducted on data from the Danish National Prescription Registry to evaluate the validity of the CID diagnoses, as it is expected that they get treatment in relation to the diseases. Data on medication and treatment of each diagnosis will be analysed separately.

Chronic Inflammatory Disease, Lifestyle and Risk of Disease

Intake of Dietary Fibre, Red and Processed Meat and Risk of Late-Onset Chronic Inflammatory Diseases: A Prospective Danish Study on the "Diet, Cancer and Health" Cohort

* Crohn's disease (yes/no)
* Ulcerative colitis (yes/no)
* Rheumatoid arthritis (yes/no)
* Axial spondyloarthritis (yes/no)
* Psoriatic arthritis (yes/no)
* Psoriasis (yes/no)
* Multiple sclerosis (yes/no)

Hospital of Southern Jutland

Odense Patient Data Explorative Network

University of Aarhus

Danish Cancer Society

University of Southern Denmark

Professor

Intake of pazopanib in agreement with drug label - fasted state

Intake of a reduced equivalent pazopanib dose with a continental breakfast

pazopanib

continental breakfast

Nielka P. van Erp, PharmD, PhD

Carla M.L. van Herpen, MD, PhD

Pazopanib (Votrient) is registered for the treatment of patients with advanced renal cell carcinoma and patients with soft tissue sarcoma who have received prior chemotherapy. It is administered at a fixed oral dose of 800 mg once daily (OD) regardless of size, age and clinical condition. It is absorbed from the gastrointestinal tract with an oral bioavailability of \~21%. Pazopanib is practically insoluble and highly permeable. When ingested with high fat food the pazopanib exposure (area under the concentration time curve (AUC)) is doubled. Common adverse effects are diarrhea and nausea. This might be caused by the non-absorbed proportion of pazopanib. A reduced dose taken with food could be a possible approach to reduce these side effects. Therefore the investigators initially want to determine the equivalent reduced dose of pazopanib when taken with a continental breakfast. Thereafter the investigators want to investigate whether the intake with food reduces the frequently reported side effects nausea and diarrhea.

Pazopanib (Votrient) is a multi targeted tyrosine kinase inhibitor of vascular endothelial growth factor receptor, (VEGFR-1, -2 en -3), platelet-derived growth factor receptor (PDGFR-α and -β), and stem cell factor receptor (c-KIT). Pazopanib is registered for the treatment of patients with advanced renal cell carcinoma and patients with soft tissue sarcoma who have received prior chemotherapy. It is administered at a fixed oral dose of 800 mg OD regardless of size, age and clinical condition. It is absorbed from the gastrointestinal tract with an oral bioavailability of \~21%. Pazopanib is practically insoluble and highly permeable. When ingested with high fat food the pazopanib exposure (area under the concentration time curve (AUC)) is doubled. Common adverse effects are diarrhea and nausea. This might be caused by the non-absorbed proportion of pazopanib. A dose reduction when ingested with food could be a logical approach to reduce these side effects; however this is not tested in patients yet. Therefore we want to perform a bioequivalent study to investigate what dose with a continental breakfast equals the dose of 800 mg in fasted conditions (study part A). In part B of the study we want to investigate whether the intake with food reduces the frequently reported side effects.

Pazopanib Tolerability When Given With Food

Improving the Tolerability of the Oral Targeted Anticancer Drug Pazopanib by Food Intake (DIET)

Determination of AUC of pazopanib when taken with a continental breakfast compared to 800 mg in fasted state (geometric mean ratio will be determined)

Number of side effects will be compared for the two treatments (with and food.

Preference of patients (by questionnaire): intake of pazopanib with or without

Radboud University Medical Center

Osteosarcoma

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 milligrams per meter square (mg/m\^2) orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence ABC (Treatment A: current \[1st generation\] tablets on Day 1 of Week 1; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 1; Treatment A: current \[1st generation\] tablets on Day 1 of Week 2; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in treatment sequence BCA (Treatment B: new \[2nd generation\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 2; Treatment A: current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.

KCP-330

Michael Kauffman, MD, Ph.D

The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st generation tablets.

A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma

An Open-Label Phase IB Trial To Evaluate the Effects of Food and Formulation on Pharmacokinetics of the Oral Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Soft-Tissue or Bone Sarcoma

AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration.

AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated), AUC0-inf was calculated as AUC0-t + Ct/ elimination rate constant (kel), where: Ct = the last observed non- zero concentration.

Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data.

Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data.

t1/2 was the terminal phase half-life, it was calculated as ln(2)/kel.

Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram \[kg\]).

Vd/F was calculated as Dose/ (kel \*AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg).

Best overall response rate was defined as the percentage of participants who achieved complete response (CR), and partial response (PR), as assessed by the RECIST v1.1 criteria. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in the short axis to less than (\<) 10 millimeter (mm). PR was defined as At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter (LD).

Duration of at least stable disease was defined as the time from the date of first dose of study treatment to first documented radiologic evidence of disease recurrence or progression as per RECIST v1.1 Criteria. Participants without evidence of progression were censored at time of last disease assessment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions also constituted progressive disease.

PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST v1.1, or death due to any cause. PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest sum of the longest diameter (SLD) recorded from baseline or the appearance of 1 or more new lesions. Participants who were last known to be alive and without evidence of progression were censored at time of last disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, or 30 days after end of treatment, participants were censored at the time of last evaluable disease assessment prior to the missed assessment.

OS was defined as the time from date first dose of study treatment to the date of death. Participants who were still alive prior to the data cutoff for final efficacy analysis, or who dropped out prior to study end, were censored at the day they were last known to be alive.

TTP was defined as the time from date of first dose of study treatment to first documented evidence of disease recurrence or progression, or death due to disease progression, whichever occurred first. Participants without evidence of progression were censored at time of last evaluable disease assessment.

GMI was defined as the ratio between the TTP with selinexor and the TTP with the most recent prior treatment. GMI was calculated, using a previously described threshold of 1.3 or greater as a sign of potential drug activity and improved overall survival.

An AE was any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a study and which does not necessarily have to have a causal relationship with this treatment. SAE defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) that and regardless of causality that: results in death, is life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 30 days following last dose or any event considered drug-related by the investigator through the end of the study.

AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur after participant's signed informed consent obtained. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 28 days following last dose or any event considered drug-related by the investigator through the end of the study. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death.

Number of participants with clinically significant laboratory abnormalities including clinical chemistry, hematology, coagulation and urinalysis. Number of participants with clinically significant laboratory abnormalities which were deemed clinically significant by the investigator were reported.

Vital signs included blood pressure (systolic blood pressure and diastolic blood pressure). Measurements were made after the participant had been resting supine for a minimum of 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator occurring at any time on treatment from normal pre-dose based on the condition met (Yes/No). Number of participants with clinically significant changes in vital signs with condition (Yes) were only reported.

Twelve lead ECGs were obtained after the participant has rested in a supine position for at least 5 minutes. Clinically significant findings were defined as such in the opinion of the investigator or designated physician occurring at any time on treatment from normal pre-dose.

Karyopharm Therapeutics Inc

Safety population consisted of all participants who received at least one dose of selinexor. As pre-specified in SAP, safety data was collected and analyzed as per the individual arms with specified treatment sequences only.

Arm 1:

Arm 2:

Arm 3:

Arm 4:

Arm 5:

Arm 6:

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence ABCD (Treatment A: fasted, tablet formulation on Day 1 of Week 1; Treatment B: high-fat meal, tablet formulation on Day 1 of Week 2; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 3; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in treatment sequence BADC (Treatment B: high-fat meal, tablet formulation on Day 1 of Week 1; Treatment A: fasted, tablet formulation on Day 1 of Week 2; Treatment D: low-fat meal, capsule formulation on Day 1 of Week 3; Treatment C: low-fat meal, tablet formulation on Day 1 of Week 4 in Cycle 1 (Weeks 1 to 4).

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 50 mg/m\^2 first generation tablets twice weekly on Days 1 and 3 of each week within 30 minutes of solid food consumption.

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence ABC (Treatment A: current \[1st generation\] tablets on Day 1 of Week 1; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 2; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence CAB (Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 1; Treatment A: current \[1st generation\] tablets on Day 1 of Week 2; Treatment B: new \[2nd generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in treatment sequence BCA (Treatment B: new \[2nd generation\] tablets on Day 1 of Week 1; Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 of Week 2; Treatment A: current \[1st generation\] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Unknown or Not Reported

Other

Race/Ethnicity, Customized

Safety population consisted of all participants who received at least one dose of selinexor.

Jatin Shah, MD

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).

Arms 1 and 2: Treatment A: Fasted, Tablet Formulation

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \[Week 2\] in Arm 1 and Day 1 \[Week 1\] in Arm 2).

Arms 1 and 2: Treatment B: High-Fat Meal, Tablet Formulation

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \[Week 3\] in Arm 1 and Day 1 \[Week 4\] in Arm 2).

Arms 1 and 2: Treatment C: Low-Fat Meal, Tablet Formulation

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).

Arms 1 and 2: Treatment D: Low-Fat Meal, Capsule Formulation

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment A: current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for Cycle 1 (Weeks 1 to 3).

Arms 4, 5, and 6: Treatment A: First Generation Tablet

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment B: new \[2nd generation\] tablets on Day 1 in Arm 4, 5 and 6 for (Weeks 1 to 3).

Arms 4, 5, and 6: Treatment B: Second Generation Tablet

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received selinexor 60 mg/m\^2 orally in randomized treatment sequence (i.e. Treatment C: suspension dose of current \[1st generation\] tablets on Day 1 and 3 in Arm 4, 5 and 6 for (Weeks 1 to 3).

Arms 4, 5, and 6: Treatment C: Oral Suspension

Pharmacokinetic (PK) population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.

Area Under the Concentration-time Curve From the Time Zero to the Last Non-zero Concentration (AUC0-t) of Selinexor

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment A: fasted, tablet formulation on Day 1 \[Week 1\] in Arm 1 and Day 1 \[Week 2\] in Arm 2).

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment B: high-fat meal, tablet formulation on Day 1 \[Week 2\] in Arm 1 and Day 1 \[Week 1\] in Arm 2).

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment C: low-fat meal, tablet formulation on Day 1 \[Week 3\] in Arm 1 and Day 1 \[Week 4\] in Arm 2).

Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 30 mg/m\^2 orally twice weekly in randomized treatment sequence (i.e. Treatment D: low-fat meal, capsule formulation on Day 1 \[Week 4\] in Arm 1 and Day 1 \[Week 3\] in Arm 2).

PK population included all participants in Arms 1, 2 and Arms 4, 5, and 6 who received selinexor, and for whom the PK profile for all treatments could be adequately characterized. Here 'overall number of participants analyzed' signifies participants who are evaluable for this outcome measure. As pre-specified in SAP and protocol Arm 3 was a non-PK group assessment, so data was not collected and analyzed for this PK outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients	NCT00375180	Head and Neck C...		18 Years -	AHS Cancer Control Alberta
Bioavailability and Food Effect Study of TKI258 (CSF Capsule vs. FMI Tablet) in Adult Patients With Advanced Solid Tumors	NCT01155713	Neoplasm Cancer Tumors	TKI258	18 Years -	Novartis
A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants	NCT06378658	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 Esomeprazole Food	18 Years - 55 Years	Bayer
Chronic Inflammatory Disease, Lifestyle and Risk of Disease	NCT03456206	Autoimmune Dise... Inflammatory Bo... Crohn Disease (... Ulcerative Coli... Arthritis, Rheu... Spondylarthropa... Arthritis, Psor... Psoriasis (PsO) Multiple Sclero...	Intake of red a... Lifestyle facto...	50 Years - 64 Years	University of Southern Denmark
Pazopanib Tolerability When Given With Food	NCT02138526	Cancer	pazopanib continental bre...	18 Years -	Radboud University Medical Center
Chronic Inflammatory Disease, Lifestyle and Risk of Disease	NCT03456206	Autoimmune Dise... Inflammatory Bo... Crohn Disease (... Ulcerative Coli... Arthritis, Rheu... Spondylarthropa... Arthritis, Psor... Psoriasis (PsO) Multiple Sclero...	Intake of red a... Lifestyle facto...	50 Years - 64 Years	University of Southern Denmark
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma	NCT01896505	Sarcoma	KCP-330	18 Years -	Karyopharm Therapeutics Inc
Effect of an Oral Supplement on the Total Energy and Protein Intake of Head and Neck Cancer Patients in the Last 2 Weeks of Radiation Therapy	NCT00375700	Head and Neck C...	Nutritional Sup...	18 Years -	AHS Cancer Control Alberta
A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants	NCT06378658	Advanced Non-sm... EGFR Mutation HER2 Mutation Healthy Volunte...	BAY2927088 Esomeprazole Food	18 Years - 55 Years	Bayer
Nutritional Status and Barriers to Dietary Intake in Head and Neck Cancer Patients	NCT00375180	Head and Neck C...		18 Years -	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for food

Every month we try and update this database with for food cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for food

Every month we try and update this database with for food cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for food cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.