Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2009-12-31
2014-12-31
Brief Summary
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Detailed Description
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Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off.
Treatment with the study drug will continue until tumor progression or unacceptable toxicity.
The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sunitinib
50 mg once daily 6 weeks cycle 4 weeks on and 2 weeks off
Sunitinib
Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks of treatment followed by 2 weeks without treatment.
Interventions
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Sunitinib
Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks of treatment followed by 2 weeks without treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No previous treatment
Exclusion Criteria
* Symptomatic and/or unstable pre-existing brain metastases
* Severe or uncontrolled cardiovascular diseases
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Principal Investigators
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Armando Santoro, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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Istituto Clinco Humanitas
Rozzano, Milano, Italy
Countries
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Other Identifiers
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ONC-2008-004
Identifier Type: -
Identifier Source: org_study_id