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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: April 11, 2012
Last updated: May 7, 2017
Last verified: May 2017
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 Intervention Phase
Neuroendocrine Tumors
Drug: RAD001
Drug: SOM230
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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"

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • investigator-assessed progression free survival (PFS) [ Time Frame: up to 4 years ]
  • best overall response [ Time Frame: up to 4 years ]

Enrollment: 17
Actual Study Start Date: May 18, 2012
Estimated Study Completion Date: October 31, 2017
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 + SOM230 Drug: RAD001
Other Name: Everolimus
Drug: SOM230
Other Name: Paseriotide


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01590199

Novartis Investigative Site
Bad Berka, Germany, 99438
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Muenster, Germany, 48149
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01590199     History of Changes
Other Study ID Numbers: CRAD001KDE47
Study First Received: April 11, 2012
Last Updated: May 7, 2017
Individual Participant Data  
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
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on May 25, 2017