COOPERATE-1: Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01263353

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).

Condition or Disease	Intervention/Treatment	Phase
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System	Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus Drug: Everolimus followed by Pasireotide LAR + Everolimus	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An 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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Functional tumors, pre-treated	Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
Experimental: Functional tumors, treatment naïve	Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
Experimental: Nonfunctional tumors, pretreated 1	Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
Experimental: Nonfunctional tumors, pretreated 2	Drug: Everolimus followed by Pasireotide LAR + Everolimus
Experimental: Nonfunctional tumors, treatment-naïve 1	Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
Experimental: Nonfunctional tumors, treatment-naïve 2	Drug: Everolimus followed by Pasireotide LAR + Everolimus

Outcome Measures

Primary Outcome Measures

Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET [3 months]

Secondary Outcome Measures

Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET [15 months]
To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy [15 months]
To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy [12 months]
To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors [15 months]
To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus [15 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor
Progressive disease within last 12 months (only patients with nonfunctional tumors)
Documented liver metastasis
Measurable disease per RECIST determined by multiphase MRI or triphasic CT

Exclusion Criteria:

Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms
Previous treatment with mTOR inhibitors or pasireotide
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novartis Investigative Site	Bad Berka	Germany	99438
2	Novartis Investigative Site	Berlin	Germany	13353
3	Novartis Investigative Site	Marburg	Germany	35039
4	Novartis Investigative Site	Muenster	Germany	48149