Clinical trialPhase 2Terminated
Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors
- Outcome
- Stopped earlyThis trial was terminated based on an interim analysis as BEZ235 did not demonstrate a progression free survival advantage to everolimus treatment. (Other)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- October 2012
- Expected end
- September 2014
- Enrollment
- 62 participants
- Sites
- 26
- Primary outcomes
- Progression Free Survival (PFS)
- Sponsor
- Industry
- Results posted
- 2016-04-07
- Last update
- 7 April 2016
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Brief summary public domain (ClinicalTrials.gov)
This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).
Detailed description public domain (ClinicalTrials.gov)
Patients with advanced (unresectable or metastatic), low to intermediate grade (histologically confirmed well and moderately differentiated) pancreatic neuroendocrine tumor (pNET) were randomized to either BEZ235 or everolimus. The study was planned to include 140 patients, with 70 patients in the BEZ235 treatment group and 70 patients in the everolimus treatment group. An interim analysis was conducted on 62 randomized patients. The study was terminated as the BEZ235 treatment did not demonstrate a progression free survival advantage to everolimus treatment.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [up to approx. 18 months]. Median, Months (95% Confidence Interval). BEZ235 (n=31): 8.2 (5.3 to NA) [Upper Limit could not be calculated due to insufficient number of events.]; Everolimus (n=31): 10.8 (8.1 to NA) [Upper Limit could not be calculated due to insufficient number of events.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate [up to approx. 18 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [up to approx. 30 months].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Treatment Failure (TTF) [up to approx. 18 months].
Papers 1
- Registry-listed results paperPhase II Study of BEZ235 versus Everolimus in Patients with Mammalian Target of Rapamycin Inhibitor-Naïve Advanced Panc… DOI 10.1634/theoncologist.2017-0144↗
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.