Overview

This trial is active, not recruiting.

Condition neuroendocrine tumors
Treatments rad001, som230
Phase phase 1
Targets mTOR, FKBP-12
Sponsor Novartis Pharmaceuticals
Start date May 2012
End date October 2017
Trial size 17 participants
Trial identifier NCT01590199, CRAD001KDE47

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
rad001 Everolimus
som230 Paseriotide

Primary Outcomes

Measure
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 Outcomes

Measure
investigator-assessed progression free survival (PFS)
time frame: up to 4 years
best overall response
time frame: up to 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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"
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.