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

Conditions: on-Small Cell Lung Cancer (phase 3b/4)
MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB
MedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IV

Registration Number: EUCTR2007-004634-17-LV

Lead Sponsor: ArQule Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 154

Inclusion Criteria

Each patient must meet the following criteria to be enrolled in this study.
1. Provide signed and dated informed consent prior to study-specific screening procedures
2. = 18 years old
3. Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IIIB/IV) NSCLC
4. At least one prior chemotherapy other than erlotinib
5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (see Appendix 2)
7. 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
8. Females of childbearing potential must have a negative serum pregnancy test
9. Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 × upper limit of normal (ULN) or = 5 × ULN with metastatic liver disease
10. Total bilirubin = 1.5 × ULN
11. Serum creatinine = 1.5 × ULN
12. Absolute neutrophil count (ANC) = 1.5 x 109/L
13. Platelets = 100 x 109/L
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

Patients who meet any of the following criteria will be excluded from the study.
1. Previously received erlotinib therapy
2. Received anti-tumor treatment for NSCLC within 4 weeks prior to randomization
3. Known or suspected central nervous system metastases
4. Pregnant or lactating
5. Significant gastrointestinal disorder, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. Crohn’s disease, ulcerative colitis, extensive gastric resection)
6. Unable or unwilling to swallow erlotinib or ARQ 197
7. Any contraindication to treatment with ARQ 197 or erlotinib
8. Any known hypersensitivity to any of the component of ARQ 197 or erlotinib
9. Other malignancies within the last five years, 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 or squamous cell carcinoma of the skin
10. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation
11. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection