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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00254267

Enrollment

Registered

2005-11-16

Start date

2005-11-30

Completion date

2012-12-31

Last updated

2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastrointestinal Stromal Tumor

Keywords

Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706

Brief summary

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.

Interventions

DRUGAMG 706

AMG 706 125mg, oral, once a day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The objective response rate as assessed by modified RECIST	Every 8 weeks

Secondary

Measure	Time frame
Duration of response, progression-free survival, time to response, overall survival, PK and safety profile	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;

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026