Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Subjects with EGFRm NSCLC who have received clinical benefit (CR, PR, SD) for at least 4 months and then progressed on an EGFR-TKI within the last 30 days will receive 150 milligram (mg) erlotinib once daily (OD) and 45 mg foretinib OD as a combination therapy until disease progression

Subjects with EGFR/WT NSCLC who have received clinical benefit (CR, PR, SD) for at least 2 months and then progressed on an EGFR-TKI within the last 30 days will receive 150 mg erlotinib OD and 45 mg foretinib OD as a combination therapy until disease progression.

Subjects with NSCLC who are predicted to be sensitive to foretinib based on biomarkers identified with preclinical or clinical data will receive 60 mg foretinib OD as a monotherapy until disease progression

Round yellow tablet containing 15 mg of foretinib will be orally administered in a dose level of 45 mg (3 x 15 mg) or 60 mg (4 x 15 mg) OD until disease progression

Foretinib

Round white tablet containing either 25 mg, 100 mg, or 150 mg of erlotinib will be orally administered in a dose level of 150 mg OD until disease progression

Erlotinib

GSK Clinical Trials

Foretinib (GSK1363089) is an investigational, oral, multikinase inhibitor involved in invasion, migration, and angiogenesis. This is a phase II, open label, uncontrolled, parallel, multi-cohort, multicenter 2-stage study to assess the safety and efficacy of foretinib and erlotinib combination therapy and foretinib monotherapy in genomic subpopulations of Non-Small-Cell Lung Cancer (NSCLC) subjects.

A Study to Evaluate Foretinib in Subjects With Non-Small-Cell Lung Cancer

A Phase II Study to Evaluate Foretinib in Genomic Subpopulations of Subjects With Non-Small-Cell Lung Cancer (NSCLC)

ORR (confirmed Complete Response \[CR\] or confirmed partial response \[PR\]) will be assessed by investigator as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Clinical laboratory assessments will include haematology, clinical chemistry and urinalysis parameters

Physical examinations will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities

Vital sign measurements will include systolic and diastolic blood pressure and pulse rate

Single 12-lead ECGs will be obtained at the scheduled time points

A thorough eye examination, including electroretinogram will be performed at the scheduled time points

Clinical benefit rate is the percentage of subjects with CR + PR + stable disease (SD)

Population PK parameters including the apparent clearance following oral dosing (CL/F), apparent volume of distribution following dosing (Vd/F), and the effect of combination therapy on CL/F will be estimated

GlaxoSmithKline

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

Phase I starting dose of 30 mg/day escalated to 45 mg/day, de-escalated to 30 mg/day; MTD for Phase II was 30 mg/day

Phase I starting dose 30 mg/day escalated to 45 mg/day; de-escalated to 30 mg/day. MTD for Phase II dose was 30 mg/day,

The purpose of this study is to assess the safety and tolerability of foretinib (also known as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma (liver cancer).

The purpose of this study is to identify the maximum tolerated dose (MTD) of foretinib (also known as GSK1363089) when used in the treatment of patients with advanced hepatocellular carcinoma (liver cancer), and to assess the safety and tolerability of that dose in this patient population.

The MTD will be identified during Phase I, by standard dose-escalation of foretinib. Then Phase II will assess the safety and tolerability of foretinib dosed at MTD.

Safety Study of Foretinib (GSK1363089) in Adults With Liver Cancer

A Phase 1/2, Open-Label, Multicenter Study of GSK1363089Gin Adult Subjects With Hepatocellular Carcinoma

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

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Disease Attributes

Estrogens

Mitogens

Progesterone

foretinib, at a continuous oral daily dose of 60 mg

Sasha Lupichuk

Daniel Rayson

The purpose of this study is to find out what effects this new drug foretinib has on this type of breast cancer, called "triple negative" breast cancer because the cancer tissue is estrogen, progesterone and HER2 receptor negative.

This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy can cause this cancer to shrink for a time, better options are needed.

A Study of Foretinib in Patients With Recurrent/Metastatic Breast Cancer

A Phase II Study of Foretinib in Patients With Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer

All patients will be assessed for response at the end of every second cycle (every 8 weeks). Response and progression will be evaluated using RECIST 1.1.

All patients will be assessed for toxicity at the end of every cycle (every 4 weeks). Adverse events will be graded using CTCAE V4.0.

Archival tissue will be collected on all patients. Pre-treatment fresh tissue biopsies CTC's will be collected on all patients entered in the second stage of accrual. Translational research studies will be done as described in protocol section 17.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Foretinib in Subjects With Non-Small-Cell Lung Cancer	NCT02034097	Cancer	Foretinib Erlotinib	18 Years -	GlaxoSmithKline
Safety Study of Foretinib (GSK1363089) in Adults With Liver Cancer	NCT00920192	Carcinoma, Hepa...	Foretinib	18 Years -	GlaxoSmithKline
A Study of Foretinib in Patients With Recurrent/Metastatic Breast Cancer	NCT01147484	Recurrent Breas...	Foretinib	18 Years -	Canadian Cancer Trials Group
Safety Study of Foretinib (GSK1363089) in Adults With Liver Cancer	NCT00920192	Carcinoma, Hepa...	Foretinib	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for foretinib

Every month we try and update this database with for foretinib 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 foretinib

Every month we try and update this database with for foretinib 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 foretinib 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.