A Study of AMG 337 in Subjects With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

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 > 470 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

• 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