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

Primary Purpose

Neuroendocrine Tumors

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
RAD001
SOM230
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors

Eligibility Criteria

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

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RAD001 + SOM230

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability
Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability

Secondary Outcome Measures

investigator-assessed progression free survival (PFS)
best overall response

Full Information

First Posted
April 11, 2012
Last Updated
April 13, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01590199
Brief Title
Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Acronym
MACS2002
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"
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 18, 2012 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAD001 + SOM230
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RAD001
Other Intervention Name(s)
Everolimus
Intervention Type
Drug
Intervention Name(s)
SOM230
Other Intervention Name(s)
Paseriotide
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability
Time Frame
up to 4 years
Title
Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability
Time Frame
up to 4 years
Secondary Outcome Measure Information:
Title
investigator-assessed progression free survival (PFS)
Time Frame
up to 4 years
Title
best overall response
Time Frame
up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Muenster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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