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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)


Phase 1
N/A
N/A
Not Enrolling
Both
Gastrointestinal Stromal Tumors

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Trial Information

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)

Inclusion 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.

Other protocol defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety and tolerability of nilotinib either as single agent or in combination with Imatinib

Outcome Description:

Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures.

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAMN107A2103E1

NCT ID:

NCT00441155

Start Date:

November 2006

Completion Date:

January 2011

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Oncology
  • Cancer
  • Imatinib-Resistant Gastrointestinal Stromal Tumors
  • GIST
  • Nilotinib
  • Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)
  • Gastrointestinal Stromal Tumors

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Dana Farber Cancer InstituteBoston, Massachusetts  02115