A Study of AMG 337 in Subjects With Advanced Solid Tumors

Status: Recruiting
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01253707 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-462


First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Eunice Kwak, MD, Massachusetts General Hospital

Site-responsible Investigators:

Dana-Farber Cancer Institute: Linda Pointon, 617-632-4391, linda_pointon@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Men or women ≥ 18 years old - Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor - Subjects with primary central nervous system (CNS) tumors or metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible providing they meet all of the following criteria: a) residual neurological symptoms grade ≤ 1; 2) no dexamethasone treatment; and c) follow-up MRI shows no new lesions appearing - Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for the dose escalation portion of the study) - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 - Competent to sign and date an Institutional Review Board approved informed consent form - Adequate hematologic and renal function as determined by laboratory blood and urine tests Exclusion Criteria: - Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug. - Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study - History of bleeding diathesis - Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension - A baseline ECG QTc > 480 ms - Active infection requiring (IV) antibiotics within 2 weeks of study enrollment - Significant gastrointestinal disorder(s), in the opinion of the investigator, that may influence drug absorption - Known positive test for HIV - Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests - Anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent - Concurrent or prior anticoagulation therapy within 7 days of study day 1 - Major surgery within 30 days of study day 1 - Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor
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