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Trial record 37 of 836 for:    Advanced | Neuroendocrine Tumors

Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs (MACS2002)

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ClinicalTrials.gov Identifier: NCT01590199
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE April 11, 2012
First Posted Date  ICMJE May 2, 2012
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE May 18, 2012
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
  • Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability [ Time Frame: up to 4 years ]
  • Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability [ Time Frame: up to 4 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2012)
  • number of adverse events (AEs) and serious adverse events (SAEs) during the study [ Time Frame: up to 4 years ]
  • summary of laboratory assessments and summary of ECG [ Time Frame: up to 4 years ]
Change History Complete list of historical versions of study NCT01590199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2012)
  • investigator-assessed progression free survival (PFS) [ Time Frame: up to 4 years ]
  • best overall response [ Time Frame: up to 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Official Title  ICMJE Extension Study to the "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 This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Drug: RAD001
    Other Name: Everolimus
  • Drug: SOM230
    Other Name: Paseriotide
Study Arms  ICMJE Experimental: RAD001 + SOM230
Interventions:
  • Drug: RAD001
  • Drug: SOM230
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: May 11, 2018)
18
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2012)
60
Actual Study Completion Date  ICMJE September 11, 2018
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion and Exclusion Criteria:

Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria:

  • The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures
  • Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study
  • No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment).

No intolerable toxicity during combination therapy with pasireotide LAR and everolimus

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 NCT01590199
Other Study ID Numbers  ICMJE CRAD001KDE47
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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 2019

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