An Open Label, Randomized Phase I/IIa Trial Evaluating MK-0646 in Combination With Erlotinib (TARCEVA™) for Patients With Recurrent Non-Small Cell Lung Cancer
- Conditions
- on-small cell lung cancerMedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
- Registration Number
- EUCTR2007-005941-39-FR
- Lead Sponsor
- aboratoires Merck Sharp & Dohme - Chibret
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 95
•Age greater than or equal to 18 years
•Histologically/cytologically documented, unresectable, locally advanced, recurrent or relapsed metastatic Stage IIIB/IV NSCLC
•Measurable disease
•ECOG performance status 0-2
•Adequate hematologic, renal, and hepatic function: ANC greater than or equal to 1,500/µl, platelet greater than or equal to 100,000/ µl, Creatinine < 1,5 ULN; T.bilirubin = 1,5 ULN, AST/ALT = 2,5 ULN, etc.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Chemotherapy or therapeutic radiotherapy within 2 weeks or
biological therapy such as bevacizumab (Avastin) within 4 weeks, prior to entering the study is not allowed
•Prior EGFR – TKI inhibitor/anti-EGFR mAb therapy is not allowed
•Prior IGF1R - TKI inhibitor/anti-IGF1R mAb therapy is not allowed
•No more than 2 prior systemic therapies
•Patient who has not completed radiotherapy with complete resolution of toxicities at least 2 weeks prior to beginning this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method