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

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)2 sites in 1 country167 target enrollmentSeptember 2008

ConditionsNon Small Cell Lung Cancer

InterventionsARQ 197 Erlotinib Placebo

DrugsARQ 197 Erlotinib Placebo

Overview

Phase: Phase 2
Intervention: ARQ 197
Conditions: Non Small Cell Lung Cancer
Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Enrollment: 167
Locations: 2
Primary Endpoint: Evaluate progression free survival (PFS) in patients treated with erlotinib plus ARQ 197 versus erlotinib plus placebo
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

August 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide signed and dated informed consent prior to study-specific screening procedures
•≥ 18 years old
•Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
•≥ one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have included erlotinib or other EGFR inhibiting agent)
•Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
•Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment
•Females of childbearing potential must have a negative serum pregnancy test
•Good organ function
•Confirmed availability of archival pathology samples (10 unstained paraffin-embedded slides) or tissue block suitable for subsequent analysis of KRAS, EGFR, and c-Met

Exclusion Criteria

•Previous receipt of erlotinib or other EGFR inhibiting therapy
•Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for radiotherapy) prior to the start of designated treatment
•Documented major surgical procedure within 4 weeks prior to randomization.
•Symptomatic central nervous system metastases either considered in the opinion of investigator to be clinically unstable or which require steroids, anti-epileptics, or other symptom-relieving medications
•Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
•Significant gastrointestinal disorder that, in opinion of Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn's disease, small or large bowel resection, malabsorbtion syndrome)
•Unable or unwilling to swallow the complete dose of erlotinib or ARQ 197
•Any known contraindication to treatment with ARQ 197 or erlotinib
•Any known hypersensitivity to any of component of ARQ 197 or erlotinib
•Other malignancy within 5 years of randomization, with the exception of adequately treated intraepithelial carcinoma of the cervix uteri, prostate carcinoma with a PSA value \< 0.2 ng/ml or basal or squamous cell carcinoma of the skin