Fallopian Cancer, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
ovarian, platinum resistant ovarian cancer
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.
Interventions
DRUGENMD-2076
275 mg (or 250 mg for BSA \< 1.65) per day in oral capsules in 28 day continuous cycles
Sponsors
CASI Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival rate | 6 months |
Countries
Canada, United States
Outcome results
None listed