George A. Fisher Jr.
Phase III, Open-Label Study of Nilotinib Versus Imatinib in GIST Patients
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Recruiting Status:
RecruitingStanford Recruiting Status:
Not yet recruitingCondition(s):
Intervention(s):
- Drug: Nilotinib (AMN107)
- Drug: imatinib (STI571)
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
- no prior therapy with imatinib or any investigational therapies (e.g .sunitinib). Note: newly diagnosed patients may have received up to 14 days imatinib treatment for disease management while awaiting study start.
- recurrent GIST after stopping adjuvant treatment with imatinib and no subsequent treatment with any other investigational therapies (for example sunitinib).
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
Key Exclusion Criteria:
1. Prior treatment with nilotinib or any other drug in this class or other targeted therapy agents with the exception of adjuvant imatinib.
2. Disease progression during adjuvant therapy with imatinib
3. Prior or concommitant malignancy that is currently clinically significant or currently requires active intervention.
4. Impaired cardiac function
Other protocol-defined inclusion/exclusion criteria may apply
Additional Study Details
Official Title:
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)Anticipated start date:
3/1/2009Lead Sponsor:
Novartis PharmaceuticalsInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- To compare Progression Free Survival (PFS) of nilotinib and imatinib when used as initial therapy in patents with unresectable and/ or metastatic GIST. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Secondary Outcomes:
- To compare disease control rate (DCR) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- To compare time to treatment failure (TTF) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- To compare overall survival (OS) of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- To compare time to progression (TTP), response rate (RR), time to tumor response and assess duration of response of nilotinib and imatinib [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- To compare safety and tolerability of nilotinib and imatinib [ Time Frame: at month 1 and then every 3 months ] [ Designated as safety issue: Yes ]
Total Number to be Enrolled:
736Total Number to be Enrolled at Stanford:
12More Information
Secondary ID(s):
- CAMN107G2301
- GIST0002
- NCT00785785
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
9/1/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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