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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01590199
First received: April 11, 2012
Last updated: June 5, 2014
Last verified: June 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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:

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 ] [ Designated as safety issue: Yes ]
  • Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability [ Time Frame: up to 4 years ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590199

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Germany
Novartis Investigative Site Recruiting
Bad Berka, Germany, 99438
Novartis Investigative Site Active, not recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Muenster, Germany, 48149
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01590199     History of Changes
Other Study ID Numbers: CRAD001KDE47
Study First Received: April 11, 2012
Last Updated: June 5, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 01, 2014