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A Phase 3, Randomized, Double-Blinded, Placebo Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects with Locally Advanced or Metastatic, Non-Squamous, Non-Small Cell Lung Cancer (NSCLC)
|ARQ 197 (Tivantinib)
- The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) in subjects with locally advanced or metastatic non-squamous NSCLC who have received 1 or 2 prior systemic anti-cancer therapies in the ITT population.
- Male of female at least 18 years of age.
- Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC.
- Measurable disease and documented disease progression following last prior therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
- Have received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be platinum-doublet therapy. Patients who received only adjuvant treatment will be eligible only if disease progression occurred < 6 months after completion of adjuvant therapy. Prior maintenance therapy is allowed and will be considered as the same line of therapy when continued without discontinuation after initiation of a treatment regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Resolution of any toxic effects of prior therapy (including radiotherapy) according to NCI CTCAE, Version 4.0, Grade ≤ 1 (with exception of alopecia). Subject must have recovered from significant surgery-related complications.
- Demonstrate adequate bone marrow, liver, and renal functions, as defined as:
- ALT, AST, and alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN) in subjects with no liver metastasis and ≤ 5.0 x ULN in subjects with liver metastasis.
- Total bilirubin ≤ 1.5 x ULN (≤ 4 x ULN total and ≤ 1.5 x ULN direct bilirubin is acceptable for subjects with Gilbert's syndrome).
- ANC ≥ 1.5 x 10^9/L.
- Platelet count ≥ 100 x 10^9/L.
- Hemoglobin ≥ 9.0 g/dL (transfusionand/or growth factor support allowed).
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mUmin.
- Must have available archival pathology samples (10 unstained, unbaked,uncharged, paraffin-embedded slides) or tissue block suitable for analysis ofKRAS, EGFR, and c-MET. (EGFR and KRAS status must be confirmed bycentral review prior to randomization.)
- If of child-bearing/reproductive potential (female or male), must agree to usedouble-barrier contraceptive measures, oral contraception, or avoidance ofintercourse during the study and for 90 days after last investigational drug dosereceived.
- If female and of childbearing potential, must have a negative result of apregnancy test (serum or urine) within 72 hours prior to initiating studytreatment.
- Must have signed and dated an IEC or IRB approved ICF (Including HIPAAauthorization, if applicable) before performance of any study-specific proceduresor tests. Subjects must be fully informed about their illness and theinvestigational nature of the study protocol (including forseeable risks andpossible side effects)
- Prior therapy with an EGFR inhibitor and/or ARQ 197 (or other known c-MET inhibitor).
- Receipt of any systemic anti-tumor treatment for NSCLC within 4 weeks prior to randomization.
- Receipt of palliative radiotherapy within 2 weeks or radiotherapy for curative intent of target lesions within 4 weeks prior to randomization. (Lesions subjected to radiotherapy within 4 weeks prior to randomization may not be used as target lesions.)
- Major surgical procedure within 4 weeks prior to randomization.
- History of cardiac disease: Congestive heart failure defined as Class II to IV per New York Heart Association classification; active coronary artery disease; previously diagnosed symptomatic bradycardia (subjects with asymptomatic bradycardia and heart rate above 50 bpm are allowed) or other cardiac arrhythmia defined as ≥ Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension; myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred > 6 months prior to study entry is permitted).
- Clinically unstable CNS metastasis (to be enrolled in the study, subjects must have confirmation of stable disease by MRI or computed tomography (CT) scan within 4 weeks of randomization and have CNS metastases well controlled by steroids, anti-epileptics or other symptom-relieving medications).
- Need to breastfeed a child during or within 12 weeks of completing the study.
- Significant gastrointestinal disorder that, in the opinion of the investigator, could interfere with absorption ofARQ 197 and/or erlotinib (eg, Crohn's disease, small or large bowel resection, malabsorption syndrome).
- Inability or unwillingness to swallow the complete doses ofARQ 197 or erlotinib.
- Any known contraindication to treatment with, including hypersensitivity to, ARQ 197 or erlotinib.
- History of malignancy other than NSCLC within the 5 years prior to randomization, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value < 0.2 ng/mL; or basal or squamous-cell carcinoma of the skin.
- Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.
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