Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Gastrointestinal Stromal Tumor Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of histological confirmed GIST
Had prior imatinib mesylate therapy
Has at least 1 measurable leasion by modified RECIST

Exclusion criteria

Central nervous system tumor involvement requiring treatment
History of myocardial infraction
Uncontrolled hypertension

Treatment and study plan

AMG 706

Drug

AMG 706 125mg, oral, once a day

Primary outcomes

The objective response rate as assessed by modified RECIST

Time frame: Every 8 weeks

Secondary outcomes

Duration of response, progression-free survival, time to response, overall survival, PK and safety profile

Time frame: imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter;

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

Takeda

Registry information

Official study title

An Open-label Phase 2 Study of AMG 706 in Japanese Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2012
First posted: Nov 16, 2005
Registry last updated: Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed