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

Sponsor
GlaxoSmithKline
Study ID
NCT02034097
Phase
PHASE2
Status
Withdrawn

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Foretinib — DRUG
    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
  • Erlotinib — DRUG
    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

Study Details

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.

Key Dates

First listed
Jan 13, 2014
Start date
Apr 30, 2014
Status verified
May 2014
Primary completion
Apr 30, 2014
Completion
Dec 31, 2016

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    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
  • Experimental: Cohort 2
    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.
  • Experimental: Cohort 3
    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

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Screening, Cycle 3 Day 1, Cycle 5 Day 1, then every 3 cycles up to 2 years ]

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