A Study of AMG 337 in Subjects With Advanced Solid Tumors

Amgen

Status and phase: Completed; Phase 1

Conditions: Tumors; Oncology; Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology Patients

Treatments: Drug: AMG 337

Study type: Interventional

Funder types: Industry

Identifiers

NCT01253707

20101132

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

Dose Escalation

Experimental group

Treatment:

Drug: AMG 337