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

December 17, 2020 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Berka, Germany, 99438
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Marburg, Germany, 35039
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (ESTIMATE)

December 20, 2010

Study Record Updates

Last Update Posted (ACTUAL)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSOM230F2102
  • 2010-018895-26 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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