A Randomized Phase 2 Study of Erlotinib + ARQ 197 Versus Erlotinib + Placebo in Previously Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Burbank, California.

Sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Study ID
NCT00777309
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ARQ 197 — DRUG
    360 mg administered twice daily until disease progression, unacceptable toxicity or other discontinuation criterion is met
  • Erlotinib — DRUG
    Erlotinib is a white, film coated tablet in strengths of 25, 100 and 150 mg administered once daily until disease progression, unacceptable toxicity or other discontinuation criterion is met.
  • Placebo — DRUG
    The placebo is provided as a capsule

Study Details

This is a randomized, placebo-controlled, double blind phase 2 study designed to compare treatment with ARQ 197 plus erlotinib to erlotinib plus placebo in patients with non-small cell lung cancer. The study will enroll patients who have had one prior chemotherapy regimen (other than erlotinib) for NSCLC.

Key Dates

First listed
Oct 22, 2008
Start date
Sep 30, 2008
Status verified
Feb 2013
Primary completion
May 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
167 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Erlotinib (150 mg) once daily plus ARQ 197 (360 mg) twice daily.
  • Active Comparator: 2
    Erlotinib (150 mg) once daily plus ARQ 197 placebo twice daily

Primary Outcome Measure

Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo

Locations (18)

FacilityCityStateZIPSite coordinators
-BurbankCalifornia91505-
-Santa MonicaCalifornia90404-
-TorringtonConnecticut06790-
-JacksonvilleFlorida32204-
-AtlantaGeorgia30309-
-ChicagoIllinois60612-
-BatesvilleIndiana47006-
-IndianapolisIndiana46107-
-LouisvilleKentucky40202-
-BostonMassachusetts02114-
-WorcesterMassachusetts01608-
-CharlotteNorth Carolina28204-
-CantonOhio44718-
-Corpus ChristiTexas78410-
-DallasTexas75246-
-DallasTexas75390-
-HoustonTexas77024-
-Salt Lake CityUtah84114-

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