Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Part of paid clinical trials in Stanford, California.

Sponsor
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Study ID
NCT01395758
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • ARQ 197 plus erlotinib — DRUG
    Eligible subjects will be randomly assigned to receive erlotinib plus ARQ 197.
  • Pemetrexed, docetaxel or gemcitabine — DRUG
    Investigator's choice of a single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered according to the approved label.

Study Details

The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.

Key Dates

First listed
Jul 18, 2011
Start date
Jul 31, 2011
Status verified
Mar 2018
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

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

Arms

  • Experimental: tivantinib (ARQ 197) plus erlotinib arm
    Eligible subjects will be randomly assigned to receive erlotinib plus tivantinib (ARQ 197). Treatment will be open-label and continue until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.
  • Active Comparator: Chemotherapy arm
    Investigator's choice of single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered in 3-week cycles according to the approved label until disease progression or unacceptable toxicity. Subjects who discontinued chemotherapy can be switched to the crossover arm (tivantinib plus erlotinib) and continue treatment until disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival (PFS) Among Subjects With KRAS Mutation Positive NSCLC (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Single Agent Chemotherapy. [ Time Frame: Date of randomization until disease progression per RECIST (v 1.1) or death from any cause, whichever came first, assessed up to 24 months. ]

Locations (13)

FacilityCityStateZIPSite coordinators
-StanfordCalifornia94305-
-Washington D.C.District of Columbia20057-
-WestonFlorida33331-
-AtlantaGeorgia30341-
-ChicagoIllinois60611-
-Kansas CityKansas66160-
-BaltimoreMaryland21205-
-BostonMassachusetts02114-
-BurlingtonMassachusetts01805-
-New YorkNew York10016-
-PittsburghPennsylvania15232-
-CharlestonSouth Carolina29425-
-DallasTexas75390-

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