NCT01590199

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2012

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

May 18, 2012

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

6.3 years

First QC Date

April 11, 2012

Last Update Submit

April 13, 2019

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • investigator-assessed progression free survival (PFS)

    up to 4 years

  • best overall response

    up to 4 years

Study Arms (1)

RAD001 + SOM230

EXPERIMENTAL
Drug: RAD001Drug: SOM230

Interventions

RAD001DRUG
Also known as: Everolimus
RAD001 + SOM230
SOM230DRUG
Also known as: Paseriotide
RAD001 + SOM230

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Bad Berka, 99438, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Everolimuspasireotide

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2012

First Posted

May 2, 2012

Study Start

May 18, 2012

Primary Completion

September 11, 2018

Study Completion

September 11, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

DE(3)