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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00089960
Recruitment Status : Completed
First Posted : August 20, 2004
Last Update Posted : April 29, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Drug: AMG 706 Phase 2

Expanded Access : Amgen has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2008

Arm Intervention/treatment
AMG 125 mg daily continuously
Drug: AMG 706
AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.

Primary Outcome Measures :
  1. Objective response rate as defined using modified RECIST criteria. [ Time Frame: 48 weeks treatment or until progressive disease, or unacceptable toxicity ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: time from randomization to progressive disease ]
  2. Overall survival [ Time Frame: time to death ]
  3. Time to progression [ Time Frame: time from response to progressive disease ]
  4. Time to response [ Time Frame: time from first treatment to response ]
  5. Patient-reported outcomes [ Time Frame: quality of life ]
  6. Use of opioid analgesics after minimal 6 months treatment [ Time Frame: narcotics usage during study ]
  7. Objective response by PET and tumor size/density changes at week 8 [ Time Frame: response rate at week 8 ]
  8. Objective response by size changes and/or target tumor density changes at week 8 [ Time Frame: response rate at week 8 ]
  9. Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related) [ Time Frame: for duration of study ]
  10. Duration of response [ Time Frame: time to respone to progression ]
  11. Palliative response [ Time Frame: amelioration of symptoms ]
  12. Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships [ Time Frame: during specific study timepoints ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00089960

Sponsors and Collaborators
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Study Director: MD Amgen
Additional Information:
Publications of Results:
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Responsible Party: Amgen Identifier: NCT00089960    
Other Study ID Numbers: 20040110
First Posted: August 20, 2004    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013
Keywords provided by Amgen:
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms by Site
Motesanib diphosphate
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action