Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer
NCT ID: NCT01104675
Last Updated: 2014-08-06
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
64 participants
INTERVENTIONAL
2010-04-30
2012-12-31
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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ENMD-2076 treatment
ENMD-2076
275 mg (or 250 mg for BSA \< 1.65) per day in oral capsules in 28 day continuous cycles
Interventions
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ENMD-2076
275 mg (or 250 mg for BSA \< 1.65) per day in oral capsules in 28 day continuous cycles
Eligibility Criteria
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Inclusion Criteria
* Have a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal
* Greater than or equal to 18 years of age
* Have clinically acceptable laboratory screening results
* Have an ECOG performance status of 0 or 1
* Able to tolerate oral medications
Exclusion Criteria
* Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec
* Have active, acute, or chronic clinically significant infections or bleeding
* Have persistent 2+ protein by urinalysis or a history of nephrotic syndrome
18 Years
FEMALE
No
Sponsors
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CASI Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Gannon, MD, MBA
Role: STUDY_DIRECTOR
CASI Pharmaceuticals, Inc.
Locations
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University of Colorado Cancer Center
Aurora, Colorado, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Dana Farber/Partners Cancer Care
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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2076-CL-004
Identifier Type: -
Identifier Source: org_study_id
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