Gastrointestinal Cancer
Conditions
Keywords
GIST
Brief summary
This study will determine the safety and effectiveness of AMG 706 in patients with advanced GIST.
Detailed description
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen Call Center (866-572-6436) for more information.
Interventions
DRUGAMG 706
AMG 706 125 mg daily for 48 weeks, or until progressive disease or unacceptable toxicity.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate as defined using modified RECIST criteria. | 48 weeks treatment or until progressive disease, or unacceptable toxicity |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | time from randomization to progressive disease |
| Overall survival | time to death |
| Time to progression | time from response to progressive disease |
| Time to response | time from first treatment to response |
| Patient-reported outcomes | quality of life |
| Use of opioid analgesics after minimal 6 months treatment | narcotics usage during study |
| Objective response by PET and tumor size/density changes at week 8 | response rate at week 8 |
| Objective response by size changes and/or target tumor density changes at week 8 | response rate at week 8 |
| Safety Endpoints: Incidence of adverse events (including all, serious, grade 3, grade 4 and treatment related) | for duration of study |
| Duration of response | time to respone to progression |
| Palliative response | amelioration of symptoms |
| Pharmacokinetic Endpoints: 1. The AMG 706 PK parameters (Cmax, t1/2, AUC0-24, C24); 2. To explore the PK/PD relationships | during specific study timepoints |
Outcome results
None listed