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A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

Phase 3
18 Years
Open (Enrolling)
Gastrointestinal Stromal Tumor (GIST)

Thank you

Trial Information

A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

Inclusion Criteria:

1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic
and either:

- have not received any prior anti-neoplastic therapy other than adjuvant
imatinib. Note: newly diagnosed patients may have received up to 14 days of
treatment with imatinib for disease management while awaiting entry to the study

- recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent
treatment with any other therapies.

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

3. Performance status ≤ 2 (capable of self-care but unable to carry out any work)

4. Normal organ, electrolyte and marrow function

Exclusion Criteria:

1. Any prior anti-neoplastic therapy with the exception of patients who have received
adjuvant imatinib or patients with newly diagnosed metastatic/ unresectable GIST
whose disease requires therapy while awaiting entry to the study.

2. Disease progression during adjuvant therapy with imatinib

3. History of active malignancy (other than GIST) within 10 years prior to study entry
with the exception of previous or concomitant basal cell skin cancer, previous
cervical carcinoma in situ.

4. Impaired cardiac function

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


Study Design:

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

Outcome Measure:

To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST.

Outcome Time Frame:

throughout the study

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

June 2013

Related Keywords:

  • Gastrointestinal Stromal Tumor (GIST)
  • Unresectable GIST
  • metastatic GIST
  • nilotinib
  • AMN107
  • imatinib
  • STI571
  • Gastrointestinal Stromal Tumors



Birmingham Hematology and Oncology Associates Birmingham, Alabama  35235
New York Oncology Hematology, P.C. NYOH Amsterdam Troy, New York  12180
Tyler Cancer Center Dept.ofTylerCancerCtr. (2) Tyler, Texas  75702
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2) San Antonio, Texas  78229
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3) Dallas, Texas  75390-8527
Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer Greenwood Village, Colorado  
Washington Hospital Center Wash Hospital Washington, District of Columbia  20010
Mayo Clinic - Rochester Division of Hematology Rochester, Minnesota  55905
University of Colorado Dept. of Univ. of Colorado Aurora, Colorado  80045
Kootenai Medical Center Dept.ofKootenai Med.Ctr. Coeur d'Alene, Idaho  83814
Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc Flagstaff, Arizona  86001
City of Hope National Medical Center Regulatory Document Duarte, California  91010-3000
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4) Duarte, California  91010-3000
University of California San Diego Dept of Moores Cancer Ctr (2) La Jolla, California  92093-0658
University of California at Los Angeles GI Oncology Program Los Angeles, California  90095
Stanford University Medical Center Stanford Cancer Center Stanford, California  94304
Ocala Oncology Center Dept. of Ocala Oncology Center Ocala, Florida  34474
Northwestern University Clinical Research Office (2) Chicago, Illinois  60611
Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology Boston, Massachusetts  02115
University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6) Ann Arbor, Michigan  48109-0944
Minnesota Oncology Hematology, P.A. SC Minneapolis, Minnesota  55404
New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2) Troy, New York  12180
University of Pennsylvania Medical Center CAMN107G2301 Philadelphia, Pennsylvania  19104-4283
Vanderbilt Univeristy Ingram Cancer Ctr. Nashville, Tennessee  37232
Texas Oncology, P.A. Tex Onc (2) Bedford, Texas  76022
Texas Oncology, P.A. Wichita Falls Dallas, Texas  75246
MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (13) Houston, Texas  77030-4009
University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3) Salt Lake City, Utah  84112