Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00718562

Purpose

This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: nilotinib	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate Sunitinib Sunitinib malate Tyrosine 4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide Malic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib

Further study details as provided by Novartis:

Primary Outcome Measures:

Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitib [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Safety [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
PK profile [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	September 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: nilotinib 400mg b.i.d

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib
At least one measurable site of disease on CT/MRI scan
PS≤2
Normal organ, electrolyte, and bone marrow function

Exclusion Criteria:

Previous treatment with nilotinib or any other drug in this class or other targeted therapy
Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry
Impaired cardiac function
Use of coumarin derivatives (i.e. warfarin)
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: NCT00718562

Contacts

Contact: Novartis Japan	81 3 3797 8748
Contact: Novartis US	862-778-8330

Locations

Japan
Novartis Investigative Site	Recruiting
Hokkaido, Japan
Novartis Investigative Site	Recruiting
Niigata, Japan
Novartis Investigative Site	Recruiting
Chiba, Japan
Novartis Investigative Site	Recruiting
Tokyo, Japan
Novartis Investigative Site	Recruiting
Kyushu, Japan
Novartis Investigative Site	Recruiting
Aichi, Japan
Novartis Investigative Site	Recruiting
Osaka, Japan
Novartis Investigative Site	Recruiting
Shizuoka, Japan

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CAMN107D1201
Study First Received:	July 16, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00718562
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Keywords provided by Novartis:

nilotinib
AMN107
Sunitinib
Sunitinib malate

Imatinib
Imatinib mesylate
Tyrosine
4-Methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide

Study placed in the following topic categories:

Imatinib
Digestive System Diseases
Digestive System Neoplasms
Sunitinib

Gastrointestinal Diseases
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009