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. - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 68

Inclusion Criteria

Patients must meet all of the following criteria to participate in this study:
1. Patient has histologically or cytologically documented, unresectable, locally advanced
or metastatic Stage IIIB/IV NSCLC that has relapsed after
chemotherapy/chemoradiotherapy.
2. Patient has a pre-study, diagnostic formalin fixed paraffin-embedded tumor tissue
sample available for correlative studies.
Sample is OPTIONAL in the Phase I portion of the study.
Sample is REQUIRED in the Phase II portion of the study.
3. Patient has measurable disease based on RECIST criteria.
4. Patient has had at least one systemic chemotherapy regimen for recurrent or
metastatic disease.
5. Patient is male or female, and 18 years of age on the day of signing informed
consent.
6. Patient has a performance status 0-2 on the ECOG Performance Scale.
7. Patient must have adequate organ function as indicated by the following laboratory values.
Female patient of childbearing potential has a negative serum/urine pregnancy test at
baseline,
9. Male and female patients, as well as their partners, must agree to use adequate
contraception during therapy with MK-0646 alone or in combination with erlotinib.
Note that simultaneous use of two reliable forms of contraception is recommended for
the entire study period and ending 28±2 days after the last dose of study drug.
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

Exclusion Criteria

A patient meeting any of the following criteria is not eligible to participate in this study:
1. Patient who has had chemotherapy or therapeutic radiotherapy within 2 weeks, or
biological therapy such as bevacizumab (Avastin ) within 4 weeks, prior to entering
the study or who has not recovered from adverse events due to agents administered
more than 4 weeks earlier to at least grade 1 or baseline.
Patient who has received prior EGFR TKI inhibitor/anti-EGFR mAb therapy or
prior IGF-1R - TKI inhibitor/anti-IGF-1R mAb therapy.
3. Patient who has received more than 2 prior systemic chemotherapy regimens for
recurrent or metastatic disease.
4. Patient who has not completed radiotherapy with complete resolution of toxicities at
least 2 weeks prior to beginning this study.
5. Patient is currently participating or has participated in a study with an investigational
compound or device within 30 days (or 5 half-lives of the investigational compound)
of initial dosing with study drug.
6. Patients with active central nervous system (CNS) metastases and/or carcinomatous
meningitis are excluded. However, patients with CNS metastases who have
completed a course of therapy would be eligible for the study provided they are
clinically stable for 3 months prior to entry as defined as: (1) no evidence of new or
enlarging CNS metastasis (2) off steroids or on a stable dose of steroids.
7. Patient with a primary central nervous system tumor.
8. Patient has known hypersensitivity to the components of 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

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