Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer
- Conditions
- Peritoneal CancerFallopian CancerOvarian 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ENMD-2076 treatment ENMD-2076 -
- Primary Outcome Measures
Name Time Method Progression free survival rate 6 months
- Secondary Outcome Measures
Name Time Method
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