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 IIIBMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IV
- Registration Number
- EUCTR2007-004634-17-DE
- Lead Sponsor
- ArQule Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 193
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. = one prior chemotherapy regimen (including adjuvant chemotherapy)(not to have
included erlotinib or other EGFR inhibiting agent)
5. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
(RECIST)
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (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)
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
14. Confirmed availability of archival pathology samples (10 unstained paraffinembedded slides) or tissue block suitable for subsequent analysis of K-ras, EGFR, and c-Met
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
Patients who meet any of the following criteria will be excluded from the study:
1. Previous receipt of erlotinib or other EGFR inhibiting therapy
2. Receipt of any anti-tumor treatment for NSCLC within 4 weeks (2 weeks for
radiotherapy) prior to the start of designated treatment
3. Documented major surgical procedure within 4 weeks prior to randomization.
4. 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
5. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives or avoidance of pregnancy measures
6. 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)
7. Unable or unwilling to swallow the complete dose of erlotinib or ARQ 197
8. Any known contraindication to treatment with ARQ 197 or erlotinib
9. Any known hypersensitivity to any of component of ARQ 197 or erlotinib
10. 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
11. Previously diagnosed grade 3 or 4 (CTCAE) bradycardia or other heart arrhythmia
12. Any other significant co-mormid condition that, in opinion of the Investigator, would impair study participation or cooperation
13. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C
virus (HCV) infection
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