QUILT-3.036: AMG 337 in Subjects With Advanced or Metastatic Solid Tumors

Exclusion Criteria

• •1. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
• •2. Inability to attend required study visits and return for adequate follow-up, as required for this protocol.
• •3. Known hypersensitivity to any component of the study medication(s).
• •4. Women who are nursing, pregnant, or planning to become pregnant during the duration of the study.
• •5. Current diagnosis of sporadic or hereditary renal cell carcinoma.
• •6. Current diagnosis or history of a second neoplasm, except the following:
• •a. Adequately treated non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
• •7. Subjects with tumors with ALK-positive rearrangement who received prior treatment with crizotinib.
• •8. History of bleeding diathesis.
• •9. Uncontrolled hypertension (systolic \> 160 mmHg and/or diastolic \> 100 mmHg) or clinically significant cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months before study day 1; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
• •10. Baseline ECG Fridericia's formula (QTcF) \> 470 ms.
• •11. Active infection requiring IV antibiotics within 2 weeks before study day 1.
• •12. Significant gastrointestinal disorder (eg, Crohn's disease, ulcerative colitis, extensive gastrointestinal resection) that in the opinion of the investigator may influence drug absorption.
• •13. Positive result of screening test for human immunodeficiency virus (HIV).
• •16. Participation in this study or in an investigational study and/or procedure with any molecularly targeted agents reported to inhibit MET within 14 days before study day 1.
• •17. Antitumor therapy, including chemotherapy, antibody therapy, retinoid therapy, or other investigational therapy, within 14 days before study day 1.
• •18. Therapeutic or palliative radiation therapy within 14 days before study day 1.
• •19. Major surgery within 28 days before study day 1.
• •20. Any comorbidity that in the opinion of the investigator may increase the risk of toxicity.
• •21. Concurrent or prior use of a strong CYP3A4 inhibitor within 14 days before study day 1, including the following: ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole.
• •22. Concurrent or prior ingestion of grapefruit, grapefruit products, or other foods known to inhibit CYP3A4 within 7 days before study day 1.
• •23. Concurrent or prior use of strong CYP3A4 inducers within 28 days before study day 1, including the following: phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and the herbal supplement St. John's Wort.