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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01590199
Collaborator
(none)
18
Enrollment
3
Locations
1
Arm
75.8
Actual Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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"
Actual Study Start Date :
May 18, 2012
Actual Primary Completion Date :
Sep 11, 2018
Actual Study Completion Date :
Sep 11, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: RAD001 + SOM230

Drug: RAD001
Other Names:
  • Everolimus

    • Drug: SOM230
    Other Names:
  • Paseriotide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability [up to 4 years]

    2. Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability [up to 4 years]

    Secondary Outcome Measures

    1. investigator-assessed progression free survival (PFS) [up to 4 years]

    2. best overall response [up to 4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Bad Berka Germany 99438
    2 Novartis Investigative Site Berlin Germany 13353
    3 Novartis Investigative Site Muenster Germany 48149

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01590199
    Other Study ID Numbers:
    • CRAD001KDE47
    First Posted:
    May 2, 2012
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuroendocrine Tumors
    Everolimus
    Pasireotide

    Study Results

    No Results Posted as of Apr 16, 2019