Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00441155

Purpose

To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: Nilotinib	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Extension to a Phase I Multicenter, Dose Escalation Study of Nilotinib in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety and tolerability of nilotinib either as single agent or in combination with Imatinib assessed by AE evaluation, incl safety lab and cardiac safety (ECG, cardiac enzymes, ECHO) measures

Secondary Outcome Measures:

To assess any clinical responses in Imatinib-resistant GIST patients. Assessment of tumor response will be made based on modified RECIST criteria - to be assessed at the end of every cycle of treatment

Estimated Enrollment:	60
Study Start Date:	November 2006

Eligibility

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

Criteria

Inclusion criteria

Documented CR, PR, or SD at the time of entry to extension study and/or possible benefit from continuing treatment in the view of the investigator.
Normal organ and marrow function as defined in core protocol (CAMN107A2103).
Extension protocol written informed consent.

Exclusion criteria

Inability to swallow the medication.
Any unresolved adverse events related to participation in the core protocol (CAMN107A2103).
A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.

Other protocol defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441155

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novatis

Novartis

More Information

Study ID Numbers:	CAMN107A2103E1
Study First Received:	February 26, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00441155
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Oncology
Cancer
Imatinib-Resistant Gastrointestinal Stromal Tumors

GIST
Nilotinib
Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)

Study placed in the following topic categories:

Imatinib
Digestive System Diseases
Digestive System Neoplasms

Gastrointestinal Diseases
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009