Pancreatic Neuroendocrine Tumors (pNET) Clinical Trial
— MACS1938Official title:
Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors
| Verified date | April 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study will estimate the treatment effect of BEZ235 relative to everolimus on progression-free survival (PFS) in patients with advanced progressive pancreatic neuroendocrine tumors.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | September 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor - Progressive disease within the last 12 months - Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic CT Exclusion Criteria: - Prior treatment with mTOR or PI3K inhibitors - Patients with more than 2 prior systemic treatment regimens - Previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4 weeks Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Novartis Investigative Site | Lyon | |
| France | Novartis Investigative Site | Montpellier Cedex 5 | |
| France | Novartis Investigative Site | Paris | |
| France | Novartis Investigative Site | Reims | |
| France | Novartis Investigative Site | Toulouse Cedex 4 | |
| Italy | Novartis Investigative Site | Bologna | BO |
| Italy | Novartis Investigative Site | Pisa | PI |
| Italy | Novartis Investigative Site | Roma | RM |
| Netherlands | Novartis Investigative Site | Amsterdam | |
| Netherlands | Novartis Investigative Site | Groningen | |
| Russian Federation | Novartis Investigative Site | Kazan | |
| Russian Federation | Novartis Investigative Site | Rostov-na-Donu | Russia |
| Spain | Novartis Investigative Site | Barcelona | Catalunya |
| Spain | Novartis Investigative Site | Hospitalet de LLobregat | Catalunya |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Switzerland | Novartis Investigative Site | Luzern | |
| United Kingdom | Novartis Investigative Site | Glasgow | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Manchester | |
| United Kingdom | Novartis Investigative Site | Sheffield | |
| United States | University of Colorado Univ Colorado | Aurora | Colorado |
| United States | Montefiore Medical Center SC | Bronx | New York |
| United States | University of Kentucky Univ Kebtucky | Lexington | Kentucky |
| United States | Cedars Sinai Medical Center SC-3 | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, France, Italy, Netherlands, Russian Federation, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression free survival (PFS) | PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 8 weeks after randomisation | up to approx. 18 months | No |
| Secondary | Type, frequency and severity of adverse events | Safety will be determined by type, frequency and severity of adverse events per CTCAEv4.03 and type, frequency and severity of laboratory toxicities per CTCAEv4.03. Patients will be followed up for the duration of the study | at minimum at each study visit and up to approx. 18 months | Yes |
| Secondary | Objective response rate | Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment | up to approx. 18 months | No |
| Secondary | Overall survival (OS) | Time from randomization to the date of death due to any cause | up to approx. 30 months | No |
| Secondary | Time to treatment failure (TTF) | Time from randomization to the date of the first of the following events:death due to any cause or progressive disease, treatment discontinuation due to toxicity or treatment discontinuation due to patient preference | up to approx. 18 months | No |