Status:
COMPLETED
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)
Lead Sponsor:
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Th...
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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
- Previously diagnosed grade 3 or 4 (CTCAE) bradycardia or other heart arrhythmia
- Any other significant co-mormid condition that, in opinion of the Investigator, would impair study participation or cooperation
- Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00777309
Start Date
September 1 2008
End Date
August 1 2011
Last Update
February 28 2013
Active Locations (38)
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1
Burbank, California, United States, 91505
2
Santa Monica, California, United States, 90404
3
Torrington, Connecticut, United States, 06790
4
Jacksonville, Florida, United States, 32204