Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
NCT ID: NCT00969917
Last Updated: 2015-04-14
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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WITHDRAWN
PHASE2
INTERVENTIONAL
2010-01-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IPI-504
IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment
IPI-504
IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment
Interventions
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IPI-504
IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment
Eligibility Criteria
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Inclusion Criteria
* Histologic diagnosis of dedifferentiated liposarcoma.
* Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading.
* At least one prior chemotherapy regimen for dedifferentiated liposarcoma.
* No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted.
* Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST (version 1.1) with at least one measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
* Life expectancy ≥6 months.
Exclusion Criteria
* Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
* Patients with prior hepatic resections or hepatic-directed therapy
* Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.
18 Years
ALL
No
Sponsors
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Infinity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Infinity Pharmaceuticals
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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IPI-504-09
Identifier Type: -
Identifier Source: org_study_id
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