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Foretinib

Phase 2

Carcinoma, Renal Cell | Small molecule | Oncology |GSK plc|Trials Updated: Aug 4, 2023

Foretinib development status

Highest phase Phase 2
Registered trials 6 across 2 sponsors since Jul 2008

Foretinib target and mechanism

Molecular targetKIT, TEK, FLT1, FLT4, KDR, MET
Target classInhibitor
ModalitySmall molecule

Also known as foretinib (formerly GSK1363089 or XL880), GSK1363089 (formerly XL880)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials4
Total Enrollment185

FDA Designations

No designations recorded

Foretinib clinical trials

Foretinib · 4 trials · 4 indications

Phase 2 2Phase 1 2
NCT01147484A Study of Foretinib in Patients With Recurrent/Metastatic Breast CancerRecurrent Breast Cancer
COMPLETED47 Analytics
NCT00726323A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)Carcinoma, Renal Cell
COMPLETED74 Analytics
PHASE2COMPLETED
A Study of Foretinib in Patients With Recurrent/Metastatic Breast Cancer
Recurrent Breast CancerUnlock trial analytics
PHASE2COMPLETED
A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)
Carcinoma, Renal CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response and early progression rate
Every 8 weeks

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.

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0
At the end of forth year

Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator's assessment of the target and non target lesions.

Toxicity, maximum administered dose and the recommended phase II dose
every 4 weeks

Adverse events will be graded using CTCAE V4.0

The maximum tolerated dose (MTD)
up to 2 years
Safety and tolerability of foretinib at the MTD as measured by number and severity of AEs
up to 2 years

Secondary Endpoints

Adverse Events as a Measure of Safety and Tolerability
every 4 weeks
Relationship between response and biomarkers
2 years (end of study)
Biomarkers in Tumour cells
2 years (end of study)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ForetinibEXPERIMENTAL -
5/9 dosingEXPERIMENTAL240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days.
daily dosingEXPERIMENTAL80 mg foretinib on a daily dosing regimen
Foretinib and LapatinibEXPERIMENTALPatients will receive foretinib as a continuous oral dose, and lapatinib as a continuous oral dose. Lapatinib will commence on Day1, Cycle 1 and foretinib will commence on Day 3, Cycle 1.

Interventions

NameTypeDescription
ForetinibDRUGforetinib, at a continuous oral daily dose of 60 mg
foretinib (formerly GSK1363089 or XL880)DRUGtreatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule
LapatinibDRUGDaily oral dosing at assigned dose beginning day 1 cycle 1.
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of invasive breast cancer, that is estrogen receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER2) negative. * Formalin fixed paraffin embedded tissue available for cen...

Countries:CanadaUnited StatesHong KongTaiwanThailand
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Frequently asked questions about Foretinib

What is foretinib?

Foretinib is an investigational small molecule kinase inhibitor being developed by GSK plc for the treatment of solid tumors. It has been studied in breast cancer, hepatocellular carcinoma, and renal cell carcinoma. It is not approved and remains in clinical development, with completed trials in recurrent breast cancer, metastatic breast cancer, liver cancer, and papillary renal cell carcinoma.

What is foretinib used for?

Foretinib has been studied in recurrent and metastatic breast cancer, hepatocellular carcinoma, and renal cell carcinoma, including papillary renal cell carcinoma. All of these are investigational uses in clinical trials, not approved indications. The trials were conducted in Canada, the United States, Hong Kong, Taiwan, and Thailand.

What does foretinib target?

Foretinib inhibits the kinases KIT, TEK, FLT1, FLT4, KDR, and MET. It is a small molecule inhibitor targeting these receptor tyrosine kinases, which are involved in tumor growth, angiogenesis, and cell signaling pathways relevant to cancer progression.

Who is developing foretinib?

Foretinib is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials studying foretinib in breast cancer, hepatocellular carcinoma, and renal cell carcinoma.

What phase is foretinib in?

Foretinib is in Phase 1 development and is investigational. It has not been approved by the FDA. Clinical trials have been completed, including Phase 1 and Phase 2 studies, but no active trials are currently ongoing.

What clinical trials is foretinib in?

Foretinib has been studied in four completed clinical trials: NCT01147484 in recurrent or metastatic breast cancer, NCT01138384 in combination with lapatinib in metastatic breast cancer, NCT00920192 in hepatocellular carcinoma, and NCT00726323 in papillary renal cell carcinoma. All trials are completed and no active trials are ongoing.

Is foretinib the same as GSK1363089 or XL880?

Yes, foretinib is the same drug as GSK1363089 and XL880. Foretinib was formerly known by these names, and the trial NCT00726323 was conducted under the name GSK1363089, formerly XL880, for papillary renal cell carcinoma.