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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00441155

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Nilotinib, Imatinib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monotherapy: AMN107 initial dose of imatinib (dose level 1) was 400 mg bid was administered orally on a continuous daily schedule and was not escalated during the study	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.
Active Comparator: Combination Therapy: AMN107 + Imatinib six possible doses of Nilotinib (100 mg once daily (qd), 200 mg qd, 400 mg qd, 200 mg bid, 300 mg bid, and 400 mg bid). four possible doses of Imatinib (0 mg, 400 mg qd, 600 mg qd, and 400 mg bid).the initial dose of nilotinib (dose level 1) was 200 mg qd and could have been escalated up to 400 mg bid	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.

Arm

Intervention/Treatment

Experimental: Monotherapy: AMN107

initial dose of imatinib (dose level 1) was 400 mg bid was administered orally on a continuous daily schedule and was not escalated during the study

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.

Active Comparator: Combination Therapy: AMN107 + Imatinib

six possible doses of Nilotinib (100 mg once daily (qd), 200 mg qd, 400 mg qd, 200 mg bid, 300 mg bid, and 400 mg bid). four possible doses of Imatinib (0 mg, 400 mg qd, 600 mg qd, and 400 mg bid).the initial dose of nilotinib (dose level 1) was 200 mg qd and could have been escalated up to 400 mg bid

Drug: Nilotinib, Imatinib

Outcome Measures

Primary Outcome Measures

Safety and tolerability of nilotinib either as single agent or in combination with Imatinib [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]
Assessed by AE evaluation, including safety laboratory 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 [every 3 months, at completion of every third treatment cycle prior to first dose of next cycle, at study completion visit]
Assessment of tumor response will be made based on modified RECIST criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
2	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111-2497
3	Novartis Investigative Site	Lyon Cedex		France	69373
4	Novartis Investigative Site	Milano	MI	Italy	20133