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

CASI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Peritoneal Cancer; Ovarian Cancer; Fallopian Cancer

Treatments: Drug: ENMD-2076

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104675

2076-CL-004

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

ENMD-2076 treatment

Experimental group

Treatment:

Drug: ENMD-2076