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A Randomized, Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib Versus Best Supportive Care With or Without a Tyrosine Kinase Inhibitor (Investigator's Choice) in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Both Imatinib and Sunitinib


Phase 3
18 Years
N/A
Not Enrolling
Both
Gastrointestinal Stromal Tumors

Thank you

Trial Information

A Randomized, Open-label, Multi-center Study to Evaluate the Efficacy of Nilotinib Versus Best Supportive Care With or Without a Tyrosine Kinase Inhibitor (Investigator's Choice) in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Both Imatinib and Sunitinib

Inclusion Criteria


Inclusion criteria (Core Phase):

- Age ≥18 years

- Radiological confirmation of disease progression during imatinib and sunitinib
therapy OR intolerance to imatinib and/or sunitinib

- At least one measurable site of disease on CT/MRI scan

- Physically fit even if not able to work

- Normal organ, electrolyte, and bone marrow function

Inclusion criteria (Extension Phase):

- Patients whose tumors had progressed on the control arm and had crossed over to the
nilotinib arm.

- The study was stopped due to meeting the primary efficacy endpoint of PFS at the
interim analysis.

- Patients who were still being treated at the close of the Core study on the control
arm or nilotinib arm (whose tumors have not progressed at the time of the end of the
Core study).

- Patients must have had documented, confirmed stable, partial or complete response as
defined by the RECIST criteria at the time of entry into the Extension study with the
exception of patients who had progressed on the control arm.

Exclusion criteria (Core Phase):

- Previous treatment with nilotinib or any other drug in this class or other targeted
therapy

- Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks prior to
study entry

- Impaired cardiac function

- Use of coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)

- Women who are pregnant or lactating

Exclusion criteria (Extension Phase):

- Use of other anticancer treatments or investigational drugs (with exception of the
study drugs)

- Patients with a history of noncompliance with study drug treatment in the Core study
protocol.

Other protocol-defined inclusion/exclusion criteria applied

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) From Central Radiology Review Based on Primary Analysis (Data Cut-off: June, 2008)

Outcome Description:

Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions or the appearance of one or more new lesions.

Outcome Time Frame:

Up to 16 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CAMN107A2201

NCT ID:

NCT00471328

Start Date:

March 2007

Completion Date:

June 2011

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • GIST
  • adults
  • imatinib resistant
  • sunitinib resistant
  • AMN107
  • nilotinib
  • treatment
  • Gastrointestinal stromal tumor (GIST)
  • Gastrointestinal Stromal Tumors

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Washington Hospital Center - Washington Cancer InstituteWashington, District of Columbia  20010
University of Chicago HospitalChicago, Illinois  60637-1470
University of Texas/MD Anderson Cancer CenterHouston, Texas  77030
UCLA's Jonsson Comprehensive Cancer CenterLos Angeles, California  90095-1781
Wayne State University/Wertz Clinical Cancer CenterDetroit, Michigan  48201
Washington University School of Medicine - Siteman Cancer CenterSt. Louis, Missouri  63110