Study of AMG 706 in Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs)
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00089960
First received: August 18, 2004
Last updated: April 25, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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 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 May 22, 2013