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

Novartis

Status and phase: Completed; Phase 1

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: Nilotinib, Imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441155

CAMN107A2103E1

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Monotherapy: AMN107

Experimental group

Description:

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

Treatment:

Drug: Nilotinib, Imatinib

Combination Therapy: AMN107 + Imatinib

Active Comparator group

Description:

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

Treatment:

Drug: Nilotinib, Imatinib