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Trial record 31 of 836 for:    Advanced | Neuroendocrine Tumors

Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs (COOPERATE-1)

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ClinicalTrials.gov Identifier: NCT01263353
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE December 16, 2010
First Posted Date  ICMJE December 20, 2010
Last Update Posted Date April 21, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with progressive metastatic GEP-NET [ Time Frame: 3 months ]
Change History Complete list of historical versions of study NCT01263353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2011)
  • Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET [ Time Frame: 15 months ]
  • To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy [ Time Frame: 15 months ]
  • To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy [ Time Frame: 12 months ]
  • To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors [ Time Frame: 15 months ]
  • To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus [ Time Frame: 15 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
  • Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with progressive metastatic GEP-NET [ Time Frame: 15 months ]
  • To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy [ Time Frame: 15 months ]
  • To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy [ Time Frame: 12 months ]
  • To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors [ Time Frame: 15 months ]
  • To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus [ Time Frame: 15 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Official Title  ICMJE An Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study
Brief Summary The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
Intervention  ICMJE
  • Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
  • Drug: Everolimus followed by Pasireotide LAR + Everolimus
Study Arms  ICMJE
  • Experimental: Functional tumors, pre-treated
    Intervention: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
  • Experimental: Functional tumors, treatment naïve
    Intervention: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
  • Experimental: Nonfunctional tumors, pretreated 1
    Intervention: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
  • Experimental: Nonfunctional tumors, pretreated 2
    Intervention: Drug: Everolimus followed by Pasireotide LAR + Everolimus
  • Experimental: Nonfunctional tumors, treatment-naïve 1
    Intervention: Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
  • Experimental: Nonfunctional tumors, treatment-naïve 2
    Intervention: Drug: Everolimus followed by Pasireotide LAR + Everolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2013)
36
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2010)
60
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor
  • Progressive disease within last 12 months (only patients with nonfunctional tumors)
  • Documented liver metastasis
  • Measurable disease per RECIST determined by multiphase MRI or triphasic CT

Exclusion Criteria:

  • Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms
  • Previous treatment with mTOR inhibitors or pasireotide
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01263353
Other Study ID Numbers  ICMJE CSOM230F2102
2010-018895-26 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2016

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