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

NCT01068587 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-08-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

MET/VEGFR2 inhibitor Foretinib

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.

DRUG

erlotinib hydrochloride

erlotinib PO daily dosing starting cycle 1 day 1. Recommended Phase II dose to be determine in Phase I.

OTHER

laboratory biomarker analysis

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Natasha Leighl, MD, FRCPC · Princess Margaret Hospital, Canada

  • Cheryl Ho, MD · British Columbia Cancer Agency

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-21
Primary Completion
2014-03-21
Completion
2015-02-13

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068587 on ClinicalTrials.gov