BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
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:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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.|
- Stage 1 - Progression Free Survival (PFS) at 16 weeks [ Time Frame: 16 weeks after the first BEZ235 administration. ] [ Designated as safety issue: No ]Stage 1 Progression Free Survival is defined as the number of progression free patients divided by the total number of patients in the full analysis set. PFS will be assessed according to local radiological assessment per modified RECIST v1.1
- Stage 2 - Progression Free Survival (PFS) [ Time Frame: from the randomization date until the date of first documented progression or date of death from any cause which ever come first, assessed up to 30 months. ] [ Designated as safety issue: No ]Stage 2 Progression Free Survival is defined as the time from the randomization date until objective tumor progression or death from any cause. PFS will be assessed according to local radiological assessment per modified RECIST v1.1
- Stage1&2 - Frequency and severity of Adverse Events (AEs) [ Time Frame: three times per month during first month of therapy, then twice a month and 30 days after study treatment termination. ] [ Designated as safety issue: No ]Measure the safety and tolerability of BEZ235 therapy by monitoring the concomitant medications, abnormal laboratory values, physical examination and other safety data as appropriate.
- Stage 1&2- Evaluate Overall Response Rate [ Time Frame: Baseline, every 8 weeks. ] [ Designated as safety issue: No ]Overall Response rate is defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1.
- Stage 1&2- Disease Control rate [ Time Frame: Baseline, every 8 weeks ] [ Designated as safety issue: No ]Disease control rate is defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1.
- Stage 1&2- Measure Duration of Response [ Time Frame: Baseline, evry 8 weeks. ] [ Designated as safety issue: No ]Duration of overall response is defined only for the responder subset: patients with confirmed complete response or partial response based on investigator's assessment. It is the elapsed time between the date of first documented response and the following date of event defined as the first documented progression or death due to underlying cancer, per RECIST version 1.1..
- Stage 2- Overall survival [ Time Frame: up to approximately 28 months ] [ Designated as safety issue: No ]Time from randomisation to the date of death due to any cause.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
The investigational study drug to be used in this trial is BEZ235, which is supplied as 300mg, 200mg and 50mg sachets. Supply as 200mg and 50mg are provided for dose reduction. Patients should be instructed to take the contents of one sachets of BEZ235 twice a day in the morning within 30 minutes after a light meal (breakfast).On stage 1-open label-30 patients will receive BEZ235 . On stage 2-double-blind setting with 99 patients additional patients-only patients randomized under BEZ arm will be treated with study medication.
Placebo Comparator: Placebo
Matching Placebo for stage 2.
|Contact: Novartis Pharmaceuticals||1-888-669-6682|
|Contact: Novartis Pharmaceuticals|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|