MET/VEGFR2 Inhibitor GSK1363089 and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone in Locally Advanced or Metastatic NSCLC That Has Not Responded to Previous Chemotherapy

Sponsor
NCIC Clinical Trials Group
Study ID
NCT01068587
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • MET/VEGFR2 inhibitor Foretinib — DRUG
    PhaseI 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 hydrochloride — DRUG
    erlotinib PO daily dosing starting cycle 1 day 1. Recommended Phase II dose to be determine in Phase I.
  • laboratory biomarker analysis — OTHER
    Tumour 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

Study Details

RATIONALE: MET/VEGFR2 inhibitor Foretinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This randomized phase I/II trial is studying the side effects of erlotinib hydrochloride when given together with or without MET/VEGFR2 inhibitor Foretinib and to see how well it works in treating patients with locally advanced or metastatic non-small cell lung cancer that has not responded to previous chemotherapy.

Key Dates

First listed
Feb 15, 2010
Start date
Jan 21, 2010
Status verified
Apr 2020
Primary completion
Mar 21, 2014
Completion
Feb 13, 2015

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Erlotinib
  • Active Comparator: Foretinib plus Erlotinib

Primary Outcome Measure

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

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