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

NCT ID: NCT00441155

Last Updated: 2013-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2011-01-31

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

Conditions

Gastrointestinal Stromal Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Nilotinib, Imatinib

Intervention Type: DRUG

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.

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

Group Type: ACTIVE_COMPARATOR

Nilotinib, Imatinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

NovartisPharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Novartis Investigative Site

Lyon, , France

Novartis Investigative Site

Milan, MI, Italy

Countries

United States; France; Italy

Other Identifiers

CAMN107A2103E1

Identifier Type: -

Identifier Source: org_study_id