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

Gastrointestinal Stromal Tumors Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441155
• Other study ID #: CAMN107A2103E1
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2007
• Last updated: May 9, 2013
• Start date: November 2006
• Est. completion date: January 2011

Study information

• Verified date: May 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Documented Complete Response, Partial Response, or Stable Disease 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Nilotinib, Imatinib
Nilotinib 50 mg and 200 mg gelatin capsules and Imatinib 100 mg and 400 mg film-coated tablets in bottles.. Medication labels for each study drug complied with the legal requirements of each country, were printed in the local language.

Locations

Country	Name	City	State
France	Novartis Investigative Site	Lyon Cedex
Italy	Novartis Investigative Site	Milano	MI
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of nilotinib either as single agent or in combination with Imatinib	Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures.	AE monitored continuously from day 1 cycle 1 to the study completion visit; safety laboratory and cardiac safety monitored every 3 treatment cycles (every 3 months) from day 1 cycle 1 to the study completion visit	Yes
Secondary	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	Assessment of tumor response will be made based on modified RECIST criteria.	every 3 months, at completion of every third treatment cycle prior to first dose of next cycle, at study completion visit	No