Efficacy of Nilotinib in Adult Patients With Gastrointestinal Stromal Tumors Resistant to Imatinib and Sunitinib.
NCT ID: NCT01289028
Last Updated: 2017-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
125 participants
INTERVENTIONAL
2008-11-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nilotinib
nilotinib 400 mg twice daily (bid).
Nilotinib
Interventions
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Nilotinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Radiologically confirmed disease progression during imatinib therapy at a dose of at least 400 mg daily and/or radiologically confirmed disease progression during sunitinib therapy OR documented intolerance to imatinib and/or sunitinib. (Patients with prior additional investigational treatment of GIST prior to study entry can be included.)
* At least one measurable site of disease on CT/MRI as defined by RECIST criteria.
Exclusion Criteria
* Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks (6 weeks for nitrosurea or mitomycin C) prior to Visit 1.
* Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.
* Impaired cardiac function at visit 1
* Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Bad Saarow, , Germany
Novartis Investigative Site
Dresden, , Germany
Novartis Investigative Site
Düsseldorf, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Freiburg im Breisgau, , Germany
Novartis Investigative Site
Halle, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Mannheim, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Genova, GE, Italy
Novartis Investigative Site
Taormina, ME, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Aviano, PN, Italy
Novartis Investigative Site
Torino, TO, Italy
Countries
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Other Identifiers
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2008-000357-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAMN107DDE05
Identifier Type: -
Identifier Source: org_study_id
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