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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590199
First Posted: May 2, 2012
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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: 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"

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: May 1, 2020
Estimated Primary Completion Date: May 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 + SOM230 Drug: RAD001
Other Name: Everolimus
Drug: SOM230
Other Name: Paseriotide

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590199


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01590199     History of Changes
Other Study ID Numbers: CRAD001KDE47
First Submitted: April 11, 2012
First Posted: May 2, 2012
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Everolimus
Sirolimus
Pasireotide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists