Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00254267

Advanced Gastrointestinal Stromal Tumor

COMPLETED PHASE2

Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

NCT00135005

Gastrointestinal Stromal Tumors

COMPLETED PHASE1

Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors

NCT04933669

Progression-free Survival Gastrointestinal Stromal Tumor Neoadjuvant

RECRUITING PHASE2

MEK162 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)

NCT01991379

Gastrointestinal Stromal Tumor (GIST)

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Adjuvant Imatinib in High-risk Gastrointestinal Stromal Tumor (GIST) With C-kit Mutation

NCT00278876

Sarcoma Gastrointestinal Stromal Tumors

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm

AMG 125 mg daily continuously

Group Type OTHER

AMG 706

Intervention Type DRUG

AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AMG 706

AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years;
* Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) during previous treatment with imatinib mesylate at least 600 mg daily for at least 8 weeks, as per two independently assessed prestudy computerized tomography (CT) scans;
* Presence of at least one measurable (per RECIST)
* Progressing tumor lesion not previously treated with radiotherapy or embolization and evaluable by CT scan or magnetic resonance imaging (MRI);
* Karnofsky performance status ≥ 60;
* imatinib treatment terminated at least 7 days before study day 1;
* Adequate hepatic, renal, and cardiac function.

Exclusion Criteria

* Prior malignancy (other than GIST, in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years; cardiac disease including myocardial infarction, unstable angina, and congestive heart failure (New York Heart Association class \> II),
* uncontrolled hypertension (systolic \> 145 mmHg or diastolic \> 85 mmHg),
* History of arterial thrombosis or deep vein thrombosis (including pulmonary embolus) within 1 year of study day 1;
* Absolute neutrophil count \< 1.5x109/L, platelet count \< 100x109/L, hemoglobin \< 9.0 g/dL;
* Prior treatment with motesanib diphosphate or other KIT (except imatinib) or VEGF inhibitors.
* The study was approved by the institutional review board of each participating institution, and all patients provided written informed consent before any study-related procedures were performed.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No