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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CASI Pharmaceuticals, Inc.

Criteria

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

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