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

This study is currently recruiting participants.
Verified November 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01263353
First received: December 16, 2010
Last updated: November 12, 2012
Last verified: November 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
 Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
Drug: Everolimus followed by Pasireotide LAR + Everolimus
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
  • To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263353

Contacts
Contact: Novartis Pharmaceuticals +1(800)340-6843

Locations
Germany
Novartis Investigative Site Recruiting
Bad Berka, Germany, 99438
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Withdrawn
Heidelberg, Germany, 69120
Novartis Investigative Site Recruiting
Marburg, Germany, 35039
Novartis Investigative Site Recruiting
Muenster, Germany, 48149
Novartis Investigative Site Recruiting
Tübingen, Germany, 72076
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01263353     History of Changes
Other Study ID Numbers: CSOM230F2102, 2010-018895-26
Study First Received: December 16, 2010
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration
Germany : Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by Novartis:
Carcinoid tumor,
Gastroenteropancreatic Neuroendocrine Tumors,
Pulmonary Neuroendocrine Tumors,
pasireotide LAR,
SOM230 LAR,
 everolimus,
RAD001,
Advanced Neuroendocrine Tumor,
Gastroenteropancreatic System

Additional relevant MeSH terms:
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
 Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013