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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00089960
First received: August 18, 2004
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Gastrointestinal Cancer
Drug: AMG 706
Phase 2

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Objective response rate as defined using modified RECIST criteria. [ Time Frame: 48 weeks treatment or until progressive disease, or unacceptable toxicity ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: time from randomization to progressive disease ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: time to death ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: time from response to progressive disease ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: time from first treatment to response ] [ Designated as safety issue: No ]
  • Patient-reported outcomes [ Time Frame: quality of life ] [ Designated as safety issue: No ]
  • Use of opioid analgesics after minimal 6 months treatment [ Time Frame: narcotics usage during study ] [ Designated as safety issue: No ]
  • Objective response by PET and tumor size/density changes at week 8 [ Time Frame: response rate at week 8 ] [ Designated as safety issue: No ]
  • Objective response by size changes and/or target tumor density changes at week 8 [ Time Frame: response rate at week 8 ] [ Designated as safety issue: No ]
  • Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related) [ Time Frame: for duration of study ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: time to respone to progression ] [ Designated as safety issue: No ]
  • Palliative response [ Time Frame: amelioration of symptoms ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: October 2004
Study Completion Date: June 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm
AMG 125 mg daily continuously
Drug: AMG 706
AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089960

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00089960     History of Changes
Other Study ID Numbers: 20040110
Study First Received: August 18, 2004
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
GIST

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014