Status:
COMPLETED
A Study of Nilotinib Versus Imatinib in GIST Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Gastrointestinal Stromal Tumor (GIST)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT00785785
Start Date
March 1 2009
End Date
October 1 2014
Last Update
June 16 2016
Active Locations (165)
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1
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States, 35205
2
Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc
Flagstaff, Arizona, United States, 86001
3
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)
Duarte, California, United States, 91010-3000
4
City of Hope National Medical Center Regulatory Document
Duarte, California, United States, 91010-3000