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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.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Pancreatic Neuroendocrine Tumors (pNET)

Thank you

Trial Information

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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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)

Other protocol defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Stage 1 - Progression Free Survival (PFS) at 16 weeks

Outcome Description:

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

Outcome Time Frame:

16 weeks after the first BEZ235 administration.

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBEZ235F2201

NCT ID:

NCT01658436

Start Date:

November 2012

Completion Date:

March 2015

Related Keywords:

  • Advanced Pancreatic Neuroendocrine Tumors (pNET)
  • pancreatic
  • neuroendocrine tumor
  • Neuroectodermal Tumors, Primitive
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell

Name

Location

Dana Farber Cancer Institute SCBoston, Massachusetts  02115
Oregon Health & Science University Knight Cancer InstitutePortland, Oregon  97239
Ohio State Comprehensive Cancer Center/James Cancer Hospital SCColumbus, Ohio  43210
Montefiore Medical Center SC-2Bronx, New York  10467
Indiana University SCIndianapolis, Indiana  46202