Efficacy and Safety of AMN107 (Nilotinib)Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib - Extension - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00488150

Purpose

The study will evaluate the long term safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who are intolerant to the first and second line treatments

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: Nilotinib Drug: Best supportive care + imatinib or sunitinib	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Extension to a Randomized, Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib Versus Best Supportive Care With or Without a Tyrosine Kinase Inhibitor (Investigator's Choice) in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Both Imatinib and Sunitinib

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate Sunitinib malate Sunitinib AMN 107

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Overall survival (according to the randomized treatment) [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events (according to the randomized treatment) [ Time Frame: at the end of he study ] [ Designated as safety issue: No ]
Overall survival after treatment crossover [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Progression free survival after treatment crossover according to the investigator's assessment [ Time Frame: at end of the study ] [ Designated as safety issue: No ]
Best overall response after treatment crossover according to the investigator's assessment [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Adverse events after treatment crossover [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Enrollment:	109
Study Start Date:	July 2007
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Nilotinib 400mg twice daily	Drug: Nilotinib Other Name: AMN107
Experimental: BSC + imatinib or sunitinib BSC = Best Supportrive Care	Drug: Best supportive care + imatinib or sunitinib

Eligibility

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

Criteria

Inclusion criteria:

Patients must be enrolled in the Core protocol (CAMN107A2201) and must meet the Extension study entry criteria:

Patients whose tumors have progressed on the control arm and have crossed over to the nilotinib arm
The Core study is stopped due to meeting the primary efficacy endpoint at the interim analysis
Patients who are still being treated at the close of the Core study on the control arm or nilotinib arm (whose tumors have not progressed at the time of the end of the Core study).
Patients must have documented, confirmed stable, partial or complete response as defined at the time of entry into the Extension study with the exception of patients who have progressed on the control arm and crossed over to the nilotinib arm

Exclusion criteria:

Use of other anticancer treatments or investigational drugs (with exception of the study drugs)
Patients with a history of noncompliance with study drug treatment in the Core protocol

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488150

Show 28 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00488150 History of Changes
Other Study ID Numbers:	CAMN107A2201E1
Study First Received:	June 19, 2007
Last Updated:	November 4, 2011
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Czech Republic: State Institute for Drug Control; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Korea: Food and Drug Administration; Italy: The Italian Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Spain: Ministry of Health and Consumption; European Union: European Medicines Agency; Switzerland: Swissmedic; Taiwan: Department of Health; United States: Food and Drug Administration

Keywords provided by Novartis:

GIST
adults
imatinib resistant
sunitinib resistant

AMN107
nilotinib
treatment
Gastrointestinal stromal tumor (GIST)

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Sunitinib
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012