Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Radium Ra 223 dichloride

Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.

This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.

Radium-223 dichloride (Xofigo, BAY88-8223)

Bayer Study Director

Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer

Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

Therapeutic/prevention measures/treatment modalities, Gr. 3/4 hematological toxicities (up to 6 months after last administration), platelet or WBC \< lower limit of normal during treatment +30 days will be followed to resolution (up to 6 months after last administration), and febrile neutropenia and hemorrhage for patients who start subsequent chemotherapy will be assessed.

Bayer

Musculoskeletal Diseases

Behaviors and Mental Disorders

Rare Diseases

Osteosarcoma

Bone Neoplasms

Quality of Life

Testosterone

Patients with metastatic castration-resistant prostate cancer (mCRPC)

Decision to initiate treatment with Radium-223 made as per investigator's routine treatment practice

Radium-223-dichloride (Xofigo, BAY88-8223)

The study drug, radium-223, gives off radiation that helps to kill cancer cells in the prostate. It is already available for patients to receive as a treatment for prostate cancer that has not responded to testosterone lowering treatment and has spread to the bones. This type of cancer is called metastatic castration-resistant prostate cancer, also called mCRPC. Sometimes, researchers continue studying an available treatment to learn more about how it affects patients' daily lives.

In this study, the researchers want to learn more about how radium-223 affects the patients' ability to do their daily tasks. The patients in this study will already be receiving treatment with radium-223 as part of their routine care. The tests and measurements in this study will be done by the patients' own doctors. The researchers will collect information about the patients' treatment and results.

The study will include patients with mCRPC who have at least 2 tumors in their bones. These patients will have recently started treatment with radium-223. The patients will have also had surgery or treatment to lower their testosterone levels. But, the treatment did not help their cancer. The study will include about 105 men in Colombia who are at least 18 years old.

All of the patients will receive radium-223 through a needle put into the vein, also called an intravenous injection. They will visit their doctor's office up to 8 times during 28 weeks. At these visits, their doctors will ask how they are feeling and what medications they are taking, and will take blood samples. The doctors will also give the patients surveys about their physical, social, and emotional health and about the symptoms of their prostate cancer.

A Study to Learn More About How Radium-223 Affects the Quality of Life of Colombian Patients With Prostate Cancer That Has Not Responded to Testosterone Lowering Treatment and Has Spread to the Bones, and to Better Understand Its Safety

Describing the Quality Of Life in Colombian Patients mCRPC Under Treatment With RADium-223.

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.

Functional Assessment of Cancer Therapy-Prostate (FACT-P): It is a multidimension, selfreport QoL instrument specifically designed for patients with prostate cancer. It consists of 39 questions items, made up by 2 parts: the 27 questions for functional assessment of cancer therapy general (FACT-G) and 12 prostate cancer subscale questions. It assesses 4 main domains which are: physical (n=7), social/family (n=7), emotional (n=6) and functional wellbeing (n=7).

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Specific module (EORTC QLQ-PR25): It is a questionnaire with score calculation is by subscales: urinary symptoms, bother due to use of incontinence aid, bowel symptoms, hormonal treatment-related symptoms, sexual activity and sexual functioning. Absolute score \[scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).

Number of cycles of Radium-223 will be measured as total number of doses received.

Line of treatment is classified as first , second or third line agent according to formulation scheme.

Patients will be classified as prior chemotherapy or chemotherapy naïve

Clinical characteristics: Eastern Cooperative Oncology Group (ECOG) 0-1, more than 2 bone metastasis, no visceral metastasis, Neutrophils: \> 1.500 L (\>1.5 x10exp9/L, Hemoglobin: \> a 10 g/dL, Platelets: \> a 100.000 (\>100x10exp9/L).

Clinical characteristics: ECOG 0-1, more than 2 bone metastasis, no visceral metastasis, Neutrophils: \> 1.500 L (\>1.5 x10exp9/L, Hemoglobin: \> a 10 g/dL, Platelets: \> a 100.000 (\>100x10exp9/L).

Prostate specific antigen (PSA) level will be measured in subject's blood from baseline and every 2 months after that in accordance with the San Gallen protocol(3) stablish in the routine clinical practice as guidelines for management. The percent change from the baseline value will be calculated as followed: (PSA level at week n - PSA level from baseline)/(PSA level from baseline)\*100

PSA level will be measured in subject's blood from baseline and every 2 months after that in accordance with the San Gallen protocol(3) stablish in the routine clinical practice as guidelines for management. The percent change from the baseline value will be calculated as followed: (PSA level at week n - PSA level from baseline)/(PSA level from baseline)\*100

Alkaline phosphatase (ALP) level will be measured in subject's blood from baseline and every 2 months after that in accordance with the San Gallen protocol(3) stablish in the routine clinical practice as guidelines for management. The percent change from the baseline value will be calculated as followed: (ALP level at week n - ALP level from baseline)/(ALP level from baseline)\*100

ALP level will be measured in subject's blood from baseline and every 2 months after that in accordance with the San Gallen protocol(3) stablish in the routine clinical practice as guidelines for management. The percent change from the baseline value will be calculated as followed: (ALP level at week n - ALP level from baseline)/(ALP level from baseline)\*100

Digestive System Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Gastrointestinal Stromal Tumors

Gastrointestinal Neoplasms

Disease Progression

Digestive System Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Diseases

Sunitinib

Imatinib Mesylate

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.

Sunitinib Malate (SU011248)

Pfizer CT.gov Call Center

To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.

Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

A Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate

TTR was defined as the time (in weeks) from the date of the first dose of study treatment to the date of the first documentation of objective tumor response (CR or PR based on RECIST, version 1.0) that was subsequently confirmed.

PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven't yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a \>=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.

OS was defined as the time (in weeks) from the date of the first treatment to the date of death due to any cause.

In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.

ORR was defined as the proportion of participants who achieved an objective response. A participant was considered to have an objective response if a confirmed best response of complete response (CR) or partial response (PR) was achieved according to RECIST, version 1.0. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). PR is at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

TTP was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to tumor progression. Participants last known to be 1) alive,2) on treatment or within 28 days of discontinuation from treatment and 3) progression-free were censored at the date of last objective disease assessment that verified lack of disease progression. Participants with no post baseline assessments were censored at the start date. Participants who died without prior objective disease progression and participants who discontinued treatment without objective disease progression within 28 days of last dose were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using RECIST version 1.0.

The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed. Laboratory parameters included hematology (hemoglobin, platelets, white blood cell count, lymphocytes, neutrophils, basophils, eosinophils and monocytes), liver function (total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine and uric acid), electrolytes (sodium, potassium, chloride, calcium, magnesium and phosphate), hormones (thyroxine and thyroid stimulating hormone), clinical chemistry (glucose), and urinalysis (urine protein) tests.

Physical examinations including, but not limited to, general appearance, skin, neck, eyes, ears, nose, mouth, throat, breast, lungs, heart, abdomen, rectal, lymph nodes, extremities, thyroid, musculoskeletal, and nervous system were performed.

Vital signs included blood pressure (BP), temperature, heart rate, respiration rate and body weight. The criteria for significant changes included BP: systolic BP (SBP) greater than (\>) 150 millimeters of mercury (mm Hg) and/or diastolic BP (DBP) \> 100 mm Hg, or SBP \> 200 mm Hg and/or DBP \> 110 mm Hg; temperature: \>38.3 degrees Celsius (degrees C), or increase of greater than or equal to (\>=)1.1 degrees C (baseline \>=36.8 degrees C); heart rate: \>120 beats per minute (bpm) or less than (\<) 50 bpm, or increase of \>=30 bpm or decrease of ≥30 bpm; respiration rate: \> 40 /minute or \< 8 /minute; weight: a change of 5% or more from baseline.

ECOG was used to assess participants' performance status: 0 (Fully active, able to carry on all pre-disease activities without restriction); 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work or office work); 2 (Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self-care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair); and 5 (Dead).

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.

Sutent (Sunitinib Malate)

Age, Continuous

Sex: Female, Male

Safety analysis set included all participants who started study treatment.

Pfizer ClinicalTrials.gov Call Center

Safety analysis included all participants who started study treatment.

Progression-free Survival (PFS)

Overall Survival (OS)

The per-protocol analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started study treatment.

Objective Response Rate (ORR)

Time to Tumor Progression (TTP)

All participants who started study treatment (safety analysis set) had a confirmed objective tumor response.

Time to Tumor Response (TTR)

Number of Participants With Abnormal Clinical Laboratory Measurements

Number of Participants With Significant Changes From Baseline in Physical Examination.

SBP >150 mm Hg or DBP >100 mm Hg

SBP >200 mm Hg or DBP >110 mm Hg

heart rate: <50 bpm

heart rate: >120 bpm

heart rate: >=30 bpm increase from baseline

heart rate: >=30 bpm decrease from baseline

temperature: >38.3°C

temperature: >=1.1°C increase (baseline >=36.8°C)

respiration rate: <8/minute

respiration rate: >40/minute

weight: >=5% increase from baseline

weight: >=5% decrease from baseline

Number of Participants With Significant Vital Signs Changes From Baseline

Baseline, ECOG = 0

Baseline, ECOG = 1

Baseline, ECOG = 2

Baseline, ECOG = 3

Baseline, ECOG = 4

Baseline, ECOG = 5

Last on treatment, ECOG = 0

Last on treatment, ECOG = 1

Last on treatment, ECOG = 2

Last on treatment, ECOG = 3

Last on treatment, ECOG = 4

Last on treatment, ECOG = 5

Eastern Cooperative Oncology Group (ECOG) Performance Status

The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)

Icotinib

Li Xi qing, M.D.

To determine whether dose escalation can provide a better survival to patients who failed with icotinib at routine dose.

Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased type of cancer in China with over 5 times incidence rate increase during the past 30 years. Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and larger of therapeutic window in phase I-III trials. In this study, an open , single-center, single arm phase IV trial was designed to evaluate the safety and efficacy of dose escalation of icotinib in the treatment of advanced NSCLC patients after failure with routine dose. PFS (progress free survival) is the primary end-point with OS (overall survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the secondary end-point.

Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose

An Open , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer	NCT02141438	Metastatic Cast...	Radium-223 dich...	18 Years -	Bayer
A Study to Learn More About How Radium-223 Affects the Quality of Life of Colombian Patients With Prostate Cancer That Has Not Responded to Testosterone Lowering Treatment and Has Spread to the Bones, and to Better Understand Its Safety	NCT04681144	Prostate Cancer	Radium-223-dich...	18 Years -	Bayer
Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer	NCT02141438	Metastatic Cast...	Radium-223 dich...	18 Years -	Bayer
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor	NCT00793871	Gastrointestina...	Sunitinib Malat...	18 Years -	Pfizer
Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose	NCT01465243	Non-small Cell ...	Icotinib	18 Years - 75 Years	Betta Pharmaceuticals Co., Ltd.
A Study to Learn More About How Radium-223 Affects the Quality of Life of Colombian Patients With Prostate Cancer That Has Not Responded to Testosterone Lowering Treatment and Has Spread to the Bones, and to Better Understand Its Safety	NCT04681144	Prostate Cancer	Radium-223-dich...	18 Years -	Bayer
Dose Escalation Of Icotinib In Previously Treated Patients With Routine Dose	NCT01465243	Non-small Cell ...	Icotinib	18 Years - 75 Years	Betta Pharmaceuticals Co., Ltd.

Spots Global Cancer Trial Database for phase iv

Every month we try and update this database with for phase iv 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 phase iv

Every month we try and update this database with for phase iv 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 phase iv 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.