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

Phase 1

Conditions: on-small cell lung cancer
MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer

Registration Number: EUCTR2007-005941-39-GB

Lead Sponsor: Merck & Co Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 95

Inclusion Criteria

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:
- ANC greater than or equal to 1,500/µl; Platelet greater than or equal to 100,000/ µl; Hemoglobin greater than or equal to 9 g/dL; Creatinine <1.5mg/ml; T.bilirubin = ULN, AST/ALT = 1.5x ULN, etc.
8. 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.
10. Patient, or the patient's legal representative, has voluntarily agreed to participate by giving written informed consent.
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

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.
2. 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 drug or its analogs.
9. Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
10. Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
11. Patient is, at the time of signing informed consent, a regular user (including recreational use) of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.
12. Patient is pregnant or breastfeeding, or expecting to conceive within the projected
duration of the study.
13. Patient is known to be Human Immunodeficiency Virus (HIV)-positive.
14. Patient has active Hepatitis A, B or C.
15. Patient has symptomatic ascites or pleural effusion. A patient who is clinically stable following treatment for these conditions is eligible.
16. Patient with a history of a prior malignancy with the exception of cervical
intraepithelial neoplasia; basal cell carcinoma of the skin; adequately treated localizedprostate carcinoma with PSA <1.0; or who has undergone potentially curative therapy with no evidence of that disease for five years, or who is deemed at low risk for recurrence by his/her treating physician.
17. Patient is concurrently using growth hormone (GH), or growth hormone inhibitors.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Phase I: To determine the safety and tolerability of erlotinib in combination with MK-0646 in patients with recurrent NSCLC.<br> Phase II: To evaluate the effect of the combination of erlotinib and MK-0646 on PFS in patients with recurrent NSCLC.<br> ;<br> Secondary Objective: Radiological: To quantify response rate (RR) by response criteria in solid tumors (RECIST) criteria.<br><br> Clinical: To determine overall survival (OS).<br> ;Primary end point(s): The difference in progression-free survival (PFS) between treatment groups.

Secondary Outcome Measures

Name	Time	Method

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