Symptoms and General Pathology

All Conditions

Death

TAS266

Novartis Pharmaceuticals

This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.

First in Human Trial of TAS266 in Patients With Advanced Solid Tumors

A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors

1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Gemcitabine

Pemetrexed

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

gemcitabine administered in combination with AZD6918

pemetrexed administered in combination with AZD6918

AZD6918

intravenous, doses are on an intermittent schedule

gemcitabine

intravenous, dose administered every 21-days

pemetrexed

Judith Ochs, MD

Jeffrey Infante, MD

Lia Gore, MD

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.

Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies

AstraZeneca

Judith Ochs, M.D. Medical Science Director

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid, Acute

Hodgkin Disease

Lymphoma

Leukemia, Myeloid

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Ori Efrati, MD

The aim of this study was to investigate the occurrences of respiratory symptoms risk factors and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic diseases at presentation (before treatment) and up to 3 years follow-up (study period).

Pulmonary function tests (PFTs) are a part of the routine follow-up of patients receiving anti-cancer treatment. Treatment is frequently associated with diverse pulmonary damage which may become functionally and clinically evident many years later. PFTs may help to quantify the damage in the lungs; help to evaluate the point at which lung function deviates from normal to allow early intervention before irreversible lung damage occurs and thereby to reduce morbidity and mortality.

Reliable PFTs in the preschool age have traditionally been difficult to perform, but recent publications have demonstrated that the majority of preschool children can produce reproducible forced expiratory flow volume (FEVC) curves with proper coaching techniques. This recent development may enable studying the long term effect (years) of treatment on lung function in young children suffering from hemato-oncologic diseases.

Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children

Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years

Sheba Medical Center

GSK690693

GSK Clinical Trials

This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.

Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693

An Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the AKT Inhibitor GSK690693 Given on Various Schedules in Subjects With Solid Tumors or Lymphoma

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

GlaxoSmithKline

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Endometrial Neoplasms

Genital Diseases, Female

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status

TKI258

This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.

A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

A Phase II, Open-label, Single-arm, Non-randomized, Multi-center Study to Evaluate the Efficacy of Oral TKI258 as Second-line Therapy in Patients With Either FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).

DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).

Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.

OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.

PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.

Adverse event monitoring was conducted throughout the study.

Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.

FGFR2 (MUT)

FGFR2 (WT)

Total

Age, Continuous

Sex/Gender, Customized

Study Director

Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.

Progression Free Survival (PFS) Rate

Overall Response Rate (ORR)

Disease Control Rate (DCR)

This outcome measure was not analyzed. The analysis was not required because there were too few responders.

Duration of Response (DR)

Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.

Overall Survival (OS)

Progression Free Survival (PFS)

Adverse events (serious and non-serious)

Serious adverse events

Deaths

Safety analysis set: The safety set included all participants who received at least one dose of study medication.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
First in Human Trial of TAS266 in Patients With Advanced Solid Tumors	NCT01529307	Advanced Solid ...	TAS266	18 Years -	Novartis
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918	NCT00733031	Cancer, Solid Tumors Advanced Solid ...	AZD6918 gemcitabine pemetrexed	18 Years -	AstraZeneca
Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children	NCT00552825	Acute Lymphobla... Acute Myeloblas... Solid Tumors, Hodgkin's Disea... Non-Malignant		3 Years - 7 Years	Sheba Medical Center
Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693	NCT00493818	Cancer	GSK690693	18 Years -	GlaxoSmithKline
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer	NCT01379534	Solid Tumors an... Endometrial Can... Second-line Tre... VEGF	TKI258	18 Years -	Novartis
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer	NCT01379534	Solid Tumors an... Endometrial Can... Second-line Tre... VEGF	TKI258	18 Years -	Novartis

Spots Global Cancer Trial Database for solid tumors,