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Foretinib

Phase 2

Recurrent Breast Cancer | Small molecule | Oncology |GSK plc|Last Updated: Aug 4, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

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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Competitive Landscape -Breast Cancer 402 trials (matched to "Recurrent Breast Cancer")

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Foretinib

What is Foretinib used for?

Foretinib is an investigational small molecule being studied for the treatment of several cancers, including recurrent breast cancer, breast cancer, renal cell carcinoma, and hepatocellular carcinoma. It has been evaluated in clinical trials for these oncology indications, though it remains in clinical development and is not approved.

Who makes Foretinib?

Foretinib is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored clinical trials of the drug across multiple cancer types, including renal cell carcinoma, hepatocellular carcinoma, and breast cancer.

What phase is Foretinib in?

Foretinib has been studied in Phase 1 and Phase 2 clinical trials. Its development program includes completed Phase 1 studies in liver cancer and breast cancer, as well as Phase 2 studies in renal cell carcinoma and recurrent breast cancer. It is investigational and not approved.

What clinical trials is Foretinib in?

Foretinib has been evaluated in several completed trials, including NCT00726323 for papillary renal-cell carcinoma, NCT00920192 for liver cancer, NCT01138384 for metastatic breast cancer in combination with lapatinib, and NCT01147484 for recurrent or metastatic breast cancer.

Is Foretinib the same as GSK1363089?

Yes, Foretinib is also known as GSK1363089, formerly XL880. Clinical trial records refer to the drug by both names, such as in the Phase 2 study of GSK1363089 for papillary renal-cell carcinoma.