Safety Study of AMG 228 to Treat Solid Tumors

Amgen

Status and phase: Terminated; Phase 1

Conditions: Tumors; Squamous Cell Carcinoma of the Head and Neck; Melanoma; Oncology; Advanced Malignancy; Advanced Solid Tumors; Non-small Cell Lung Cancer; Transitional Cell Carinoma of Bladder; Cancer; Oncology Patients; Colorectal Cancer

Treatments: Drug: AMG 228

Study type: Interventional

Funder types: Industry

Identifiers

NCT02437916

20140131

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
• Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion criteria

• Active autoimmune disease, history of autoimmune disease
• Treatment with immune modulators including
• Use of warfarin, factor Xa inhibitors, or direct thrombin inhibitors
• Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or investigational agent) within 28 days
• Major surgery within 28 days of study day 1

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

AMG 228 monotherapy

Experimental group

Description:

Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types.

Treatment:

Drug: AMG 228