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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Cancer

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Trial Information

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


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

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate as defined using modified RECIST criteria.

Outcome Time Frame:

48 weeks treatment or until progressive disease, or unacceptable toxicity

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20040110

NCT ID:

NCT00089960

Start Date:

October 2004

Completion Date:

June 2008

Related Keywords:

  • Gastrointestinal Cancer
  • GIST
  • Gastrointestinal Stromal Tumors
  • Gastrointestinal Neoplasms

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