BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

Completed · Phase 2

Conditions studied: Pancreatic Neuroendocrine Tumors (pNET)

In brief

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.

Key facts

Study ID

NCT01658436

Run by

Novartis Pharmaceuticals

People needed

31

Starts

2012-11-01

Expected to finish

2015-07-01

Last updated by the study team

2016-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unresectable or metastatic, histologically confirmed low or intermediate grade pancreatic neuroendocrine tumor with radiological evidence of disease progression since last treatment
• Refractory disease to treatment with mTOR inhibitor
• Measurable disease per RECIST Version 1.1 using Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
• Prior or concurrent therapy with SSA is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as a systemic treatment.
• WHO PS ≤ 1
• Adequate bone marrow function or organ function

You may not qualify if…

• Previous treatment with any PI3K or AKT inhibitor
• Discontinuation prior mTOR inhibitor therapy due to toxicity
• Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
• Radiotherapy, or major surgery within 4 weeks prior to study treatment start
• Hepatic artery embolization or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of study treatment start.
• More than 3 prior systemic treatment regimens (including cytotoxic chemotherapy, targeted therapy, immunotherapy)

Where it is running

• Indiana University SC — Indianapolis, Indiana, United States
• Dana Farber Cancer Institute GastrointestionalCancer Clinic — Boston, Massachusetts, United States
• Montefiore Medical Center SC-2 — The Bronx, New York, United States
• Ohio State Comprehensive Cancer Center/James Cancer Hospital SC — Columbus, Ohio, United States
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Florence, FI, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Rotterdam, Netherlands
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — L'Hospitalet de Llobregat, Catalonia, Spain
• Novartis Investigative Site — Madrid, Madrid, Spain
• Novartis Investigative Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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