Safety Study of AMG 228 to Treat Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-21

Study Completion Date

2016-12-12

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AMG 228 monotherapy

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

Group Type EXPERIMENTAL

AMG 228

Intervention Type DRUG

AMG 228 will be administered intravenously

Interventions

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AMG 228

AMG 228 will be administered intravenously

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No