A Study of Nilotinib Versus Imatinib in GIST Patients

Completed · Phase 3

Conditions studied: Gastrointestinal Stromal Tumor (GIST)

In brief

This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).

Key facts

Study ID

NCT00785785

Run by

Novartis Pharmaceuticals

People needed

644

Starts

2009-03-01

Expected to finish

2014-10-01

Last updated by the study team

2016-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 or
• recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other therapies.
• At least one measurable site of disease on CT/MRI scan
• Performance status ≤ 2 (capable of self-care but unable to carry out any work)
• Normal organ, electrolyte and marrow function

You may not qualify if…

• 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.
• Disease progression during adjuvant therapy with imatinib
• 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.
• Impaired cardiac function
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc — Flagstaff, Arizona, United States
• City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4) — Duarte, California, United States
• City of Hope National Medical Center Regulatory Document — Duarte, California, United States
• University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2) — La Jolla, California, United States
• University of California at Los Angeles GI Oncology Program — Los Angeles, California, United States
• Stanford University Medical Center Stanford Cancer Center — Stanford, California, United States
• University of Colorado Dept. of Univ. of Colorado — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer — Greenwood Village, Colorado, United States
• Washington Hospital Center Wash Hospital — Washington D.C., District of Columbia, United States
• Ocala Oncology Center Dept. of Ocala Oncology Center — Ocala, Florida, United States
• Kootenai Medical Center Dept.ofKootenai Med.Ctr. — Coeur d'Alene, Idaho, United States
• Northwestern University Clinical Research Office (2) — Chicago, Illinois, United States
• Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6) — Ann Arbor, Michigan, United States
• Minnesota Oncology Hematology, P.A. SC — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester Division of Hematology — Rochester, Minnesota, United States
• New York Oncology Hematology, P.C. NYOH Amsterdam — Troy, New York, United States
• New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2) — Troy, New York, United States
• University of Pennsylvania Medical Center CAMN107G2301 — Philadelphia, Pennsylvania, United States
• Vanderbilt Univeristy Ingram Cancer Ctr. — Nashville, Tennessee, United States
• Texas Oncology, P.A. Tex Onc (2) — Bedford, Texas, United States
• Texas Oncology Wichita Falls — Dallas, Texas, United States
• University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3) — Dallas, Texas, United States
• University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13) — Houston, Texas, United States
• Birmingham Hematology and Oncology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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