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

Primary Purpose

Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Pasireotide LAR followed by Pasireotide LAR + Everolimus
Everolimus followed by Pasireotide LAR + Everolimus
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System focused on measuring Carcinoid tumor,, Gastroenteropancreatic Neuroendocrine Tumors,, Pulmonary Neuroendocrine Tumors,, pasireotide LAR,, SOM230 LAR,, everolimus,, RAD001,, Advanced Neuroendocrine Tumor,, Gastroenteropancreatic System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Functional tumors, pre-treated

Functional tumors, treatment naïve

Nonfunctional tumors, pretreated 1

Nonfunctional tumors, pretreated 2

Nonfunctional tumors, treatment-naïve 1

Nonfunctional tumors, treatment-naïve 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2010
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01263353
Brief Title
Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Acronym
COOPERATE-1
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
Keywords
Carcinoid tumor,, Gastroenteropancreatic Neuroendocrine Tumors,, Pulmonary Neuroendocrine Tumors,, pasireotide LAR,, SOM230 LAR,, everolimus,, RAD001,, Advanced Neuroendocrine Tumor,, Gastroenteropancreatic System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional tumors, pre-treated
Arm Type
Experimental
Arm Title
Functional tumors, treatment naïve
Arm Type
Experimental
Arm Title
Nonfunctional tumors, pretreated 1
Arm Type
Experimental
Arm Title
Nonfunctional tumors, pretreated 2
Arm Type
Experimental
Arm Title
Nonfunctional tumors, treatment-naïve 1
Arm Type
Experimental
Arm Title
Nonfunctional tumors, treatment-naïve 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pasireotide LAR followed by Pasireotide LAR + Everolimus
Intervention Type
Drug
Intervention Name(s)
Everolimus followed by Pasireotide LAR + Everolimus
Primary Outcome Measure Information:
Title
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET
Time Frame
15 months
Title
To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy
Time Frame
15 months
Title
To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy
Time Frame
12 months
Title
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
Title
To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bad Berka
ZIP/Postal Code
99438
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13569
Description
Results for CSOM230F2102 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

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