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Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors (MACS1938)

This study is currently recruiting participants.
Verified February 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01628913
First received: June 25, 2012
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pancreatic Neuroendocrine Tumors (pNET)
 Drug: BEZ235
Drug: Everolimus
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: up to approx. 18 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Type, frequency and severity of adverse events [ Time Frame: at minimum at each study visit and up to approx. 18 months ] [ Designated as safety issue: Yes ]
    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

  • Objective response rate [ Time Frame: up to approx. 18 months ] [ Designated as safety issue: No ]
    Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment

  • Overall survival (OS) [ Time Frame: up to approx. 30 months ] [ Designated as safety issue: No ]
    Time from randomization to the date of death due to any cause

  • Time to treatment failure (TTF) [ Time Frame: up to approx. 18 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 140
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BEZ235 Drug: BEZ235
BEZ235 400 mg bid p.o. (by mouth, twice daily)
Active Comparator: Everolimus Drug: Everolimus
Everolimus 10 mg qd p.o. (by mouth, daily)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628913

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 55 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01628913     History of Changes
Other Study ID Numbers: CBEZ235Z2401, CBEZ235Z2401, 2012-000769-19
Study First Received: June 25, 2012
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Pancreatic
Neuroendocrine tumors
PNET
BEZ235
Everolimus

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive
Neuroendocrine Tumors
Adenoma, Islet Cell
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adenoma
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
 Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013