Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET (COOPERATE-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01374451
First received: June 14, 2011
Last updated: May 16, 2015
Last verified: May 2015

June 14, 2011
May 16, 2015
June 2011
February 2015   (final data collection date for primary outcome measure)
Treatment effect on progression-free survival (PFS) per RECIST 1.0 [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: No ]

PFS(progression-free survival) RECIST(Response Evaluation Criteria in Solid Tumors)

80 PFS events are expected after approximately 24 months

Same as current
Complete list of historical versions of study NCT01374451 on ClinicalTrials.gov Archive Site
  • Safety and tolerability profile of Everolimus alone or in combination with Pasireotide LAR [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: Yes ]
    80 PFS events are expected after approximately 24 months.
  • Objective Response Rate (ORR) and Disease Control Rate (DCR) [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: No ]
    80 PFS are expected after approximately 24 months
  • Duration of response (DoR) [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: No ]
    80 PFS are expected after approximately 24 months
  • Overall Survival (OS) [ Time Frame: Once 80 PFS events have occurred ] [ Designated as safety issue: No ]
    80 PFS events expected after approximately 24 months.
  • The treatment effect on PFS and to assess the predictive probability of success in a possible subsequent phase III study once 105 PFS events have been observed [ Time Frame: Once 105 PFS events have occurred ] [ Designated as safety issue: No ]
    105 PFS events expected after approximately 36 months
Same as current
Not Provided
Not Provided
 
Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Islet Cell Tumor
  • Drug: Everolimus
    Everolimus 10 mg,qd p.o. (by mouth, daily)
    Other Name: RAD001
  • Drug: Pasireotide + Everolimus
    Pasireotide LAR 60 mg q28d i.m. ( once every 28 days intramuscularly) and everolimus 10mg. qd p.o. (by mouth, daily)
    Other Name: SOM230 LAR + RAD001
  • Experimental: Paseriotide LAR + Everolimus
    Paseriotide LAR (SOM230 LAR)+ Everolimus (RAD001)
    Intervention: Drug: Pasireotide + Everolimus
  • Experimental: Everolimus
    Intervention: Drug: Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
February 2015
February 2015   (final data collection date for primary outcome measure)

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:

  • Patients currently requiring somatostatin analog treatment
  • Prior therapy with mTOR inhibitors or pasireotide
  • Patients with more than 2 prior systemic treatment regimens
  • Previous cytotoxic chemotherapy, targeted therapy, somatostatin analogs, or biotherapy within the last 4 weeks

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Denmark,   France,   Germany,   Hungary,   Italy,   Japan,   Netherlands,   New Zealand,   Spain,   Sweden,   Thailand,   Turkey,   United Kingdom
 
NCT01374451
CSOM230I2201, 2010-023183-40
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP