|Canadian Cancer Trials Group NEC.3 (A 021202) -- An Alliance-led trial entitled Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumours -- was centrally activated February 28, 2014.
Trial objectives include:
- For patients with progressive carcinoid tumors, progression-free survival (PFS defined by central review according to RECIST 1.1) will be compared between patients randomized to treatment with pazopanib versus placebo.
- Overall Survival will be compared between treatment arms.
- Objective Response Rate duration of response, and time to treatment failure will be compared between treatment arms.
- Progression Free Survival as assessed by central radiology review and local radiology review will be compared overall and within treatment arms.
- PFS at 6 months and 12 months will be estimated within each treatment arm.
- Safety and Tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm.
- Biochemical response (for chromogranin A, defined as a decrease of 50% or more in plasma chromogranin A levels from baseline and for 5-HIAA, defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of CGA and 5-HIAA.
- PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo.
Sample size is 165 patients. Any centres / investigators interested in participating in this study should contact Barbara Graham, Study Coordinator, at email@example.com or 613-533-6430.
You can access the trial-specific website by using this link ... http://www.ctg.queensu.ca/trials/gastro-intestinal/nec3/nec3.html. (Please note you may be asked for your userid and PIN.)