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Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer

Phase 2
Completed
Conditions
Peritoneal Cancer
Fallopian Cancer
Ovarian Cancer
Interventions
Drug: ENMD-2076
Registration Number
NCT01104675
Lead Sponsor
CASI Pharmaceuticals, Inc.
Brief Summary

The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites to be added.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
64
Inclusion Criteria
  • Have histologically documented diagnosis of ovarian, fallopian or peritoneal cancer that is platinum resistant.
  • 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
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Exclusion Criteria
  • Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); require two or more antihypertensive medications to control hypertension (including ACE inhibitors, beta blockers, calcium channel blockers, or diuretics)
  • 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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ENMD-2076 treatmentENMD-2076-
Primary Outcome Measures
NameTimeMethod
Progression free survival rate6 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

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

Princess Margaret Hospital

🇨🇦

Toronto, Ontario, Canada

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

University of Colorado Cancer Center

🇺🇸

Aurora, Colorado, United States

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