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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01590199

Acronym

MACS2002

Enrollment

Registered

2012-05-02

Start date

2012-05-18

Completion date

2018-09-11

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

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

Interventions

DRUGRAD001

DRUGSOM230

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability	up to 4 years
Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability	up to 4 years

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026