Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST) (NCT01323400) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Pazopanib in Gastrointestinal Stromal Tumors (GIST)
France81 participantsStarted 2011-03
Plain-language summary
The purpose of this study is to evaluate the antitumor activity of pazopanib in patients with metastatic and/or locally advanced unresectable Gastrointestinal Stromal Tumors (GIST) resistant to imatinib and sunitinib. This is a phase II, randomized, multicentre study.
Who can participate
Age range18 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Progression or intolerance after treatment with at least imatinib (400 mg and 600/800 mg/d) then sunitinib at either 50mg/d on a 4w/6w schedule or 37.5mg/d continuous dosing. Intolerance is defined as documented grade 3 or higher toxicity requiring treatment interruption as documented in patient record.
✓. Measurable disease according to RECIST v1.1.
✓. Performance status ≤ 2 (WHO).
✓. Left Ventricular Ejection Fraction (LVEF) in accordance with local standards.
✓. Adequate organ system functions as defined below:
✓. a) Females of non-childbearing potential (i.e., physiologically incapable of becoming pregnant).
Exclusion criteria
✕. Prior malignant disease (other than GIST) within 3 years prior to entry, with the exception of in situ breast cell carcinoma or in situ carcinoma of the cervix or basocellular carcinoma or spinocellular carcinoma or bladder neoplasm, treated at least 6 months before and with no evidence of relapse.
✕. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for patients with previously-treated CNS metastases, who are asymptomatic and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. CNS screening with computed tomography \[CT\] or magnetic resonance imaging \[MRI\] is required only if clinically indicated or if the subject has a history of CNS metastases.
What they're measuring
1
Progression-free survival
Timeframe: Within 16 months after the first inclusion, from the date of randomisation until the date of the first documented progression or death from any cause