Clinical trialPhase 2Completed
BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
A Multicenter, Two Stage, Phase II Study, Evaluating the Efficacy of Oral BEZ235 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- November 2012
- Expected end
- July 2015
- Enrollment
- 31 participants
- Sites
- 17
- Primary outcomes
- Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review
- Sponsor
- Industry
- Results posted
- 2016-05-02
- Last update
- 2 May 2016
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Brief summary public domain (ClinicalTrials.gov)
This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy. Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single arm, open label design and Stage 2 was planned to be a randomized, double-blind study. However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review [16 weeks after the first BEZ235 administration.]. Number, Percentage of participants (95% Confidence Interval). BEZ235 300 mg/400 mg Bid (n=31): 51.6 (35.7 to 67.3).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Stage 1- Overall Response Rate (ORR) [Baseline, every 8 weeks up to 31 months]. Number, Percentage of participants. Complete response: BEZ235 300 mg/400 mg Bid (n=31): 0.0. Partial response: BEZ235 300 mg/400 mg Bid (n=31): 0.0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Stage 1 - Disease Control Rate [Baseline, every 8 weeks up to 31 months]. Number, Percentage of participants (95% Confidence Interval). BEZ235 300 mg/400 mg Bid (n=31): 71.0 (54.8 to 83.9).
Papers 1
- Registry-listed results paperA Phase II Study of BEZ235 in Patients with Everolimus-resistant, Advanced Pancreatic Neuroendocrine Tumours. PMID 26851029↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.