A Study of Nilotinib Versus Imatinib in GIST Patients

Phase 3

Completed

• Conditions: Gastrointestinal Stromal Tumor (GIST)
• Interventions: Drug: imatinib (STI571); Drug: Nilotinib (AMN107)

• Registration Number: NCT00785785
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Study Start: 2009-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-10-21
• Results First Submitted QC: 2016-03-09
• Results First Posted: 2016-04-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 644

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 or
   • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Imatinib	imatinib (STI571)	imatinib 400 mg once daily
Nilotinib	Nilotinib (AMN107)	nilotinib 400 mg twice a day

Primary Outcome Measures

Name	Time	Method
Time to Progression Free Survival (PFS)	up to month 37	PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Trial Locations

Locations (29)

Birmingham Hematology and Oncology Associates; 🇺🇸 Birmingham, Alabama, United States

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, District of Columbia, United States

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