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MET/VEGFR2 inhibitor Foretinib

Phase 1

Lung Cancer | Small molecule | Oncology |GSK plc|Trials Updated: Aug 4, 2023

MET/VEGFR2 inhibitor Foretinib development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

MET/VEGFR2 inhibitor Foretinib clinical trials

MET/VEGFR2 inhibitor Foretinib · 1 trial · 1 indication

Phase 1 1
NCT01068587MET/VEGFR2 Inhibitor GSK1363089 and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone in Locally Advanced or Metastatic NSCLC That Has Not Responded to Previous ChemotherapyLung Cancer
COMPLETED31 Analytics
PHASE1COMPLETED
MET/VEGFR2 Inhibitor GSK1363089 and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone in Locally Advanced or Metastatic NSCLC That Has Not Responded to Previous Chemotherapy
Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The recommended phase II dose of daily oral MET/VEGFR2 inhibitor Foretinib when given in combination with standard erlotinib hydrochloride therapy (phase I)
3 years

After completion of Phase I portion of the study

Safety, tolerability, dose-limiting toxicities, and pharmacokinetic profile (phase I)
3 years

Assessed from the time of first dose. Results will be analyzed at time of final analysis

Correlation between toxicity and pharmacokinetics (phase I)
3 years

After completion of phase I

Objective tumor response rate (partial or complete response) (phase II)
After every second cycle

Secondary Endpoints

Clinical benefit (complete response, partial response, and stable disease for ≥ 8 weeks) (phase II)
8 weeks
Tumor size at 8 weeks (phase II)
8 weeks
1-year survival rate (phase II)
1 year
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ErlotinibACTIVE_COMPARATOR -
Foretinib plus ErlotinibACTIVE_COMPARATOR -

Interventions

NameTypeDescription
MET/VEGFR2 inhibitor ForetinibDRUGPhaseI and Phase II Arm A: Foretinib PO daily dosing starting cycle 1 day 15 and erlotinib PO daily dosing starting cycle 1 day 1. Recommended Phase II dose to be determine in Phase I.
erlotinib hydrochlorideDRUGerlotinib PO daily dosing starting cycle 1 day 1. Recommended Phase II dose to be determine in Phase I.
laboratory biomarker analysisOTHERTumour markers alone cannot be used to assess objective tumour response. If markers are initially above the upper normal limit, however, they must normalize for a patient to be considered in complete response
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting all of the following criteria: * Locally advanced or metastatic disease * Failed 1-2 prior chemotherapy regimen * Must be eligible to receive erlotinib therapy (i.e., patients ...

Countries:Canada
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Competitive Landscape -Lung Cancer 400 trials

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Frequently asked questions about MET/VEGFR2 inhibitor Foretinib

What is MET/VEGFR2 inhibitor Foretinib used for?

MET/VEGFR2 inhibitor Foretinib is an investigational small molecule being studied in lung cancer. Specifically, it has been evaluated in locally advanced or metastatic non-small cell lung cancer (NSCLC) that has not responded to previous chemotherapy. It is not yet approved for any indication.

What does MET/VEGFR2 inhibitor Foretinib target?

MET/VEGFR2 inhibitor Foretinib targets MET and VEGFR2. It is a small molecule designed to inhibit these receptor tyrosine kinases, which are involved in tumor growth and angiogenesis. This dual targeting approach is being explored in oncology.

Who is developing MET/VEGFR2 inhibitor Foretinib?

MET/VEGFR2 inhibitor Foretinib is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trial evaluating this agent in lung cancer.

What phase is MET/VEGFR2 inhibitor Foretinib in?

MET/VEGFR2 inhibitor Foretinib is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 1 trial has been completed.

What clinical trials is MET/VEGFR2 inhibitor Foretinib in?

MET/VEGFR2 inhibitor Foretinib has been studied in one completed Phase 1 trial, NCT01068587. This trial evaluated the drug in combination with erlotinib hydrochloride versus erlotinib hydrochloride alone in patients with locally advanced or metastatic NSCLC that had not responded to previous chemotherapy. It enrolled 31 participants in Canada.