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A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Cancer, Peritoneal Cancer

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Trial Information

A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival rate

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Carolyn Sidor, MD, MBA

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Ovarian Cancer
  • Fallopian Cancer
  • Peritoneal Cancer
  • ovarian
  • platinum resistant ovarian cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Colorado Cancer Center Denver, Colorado  80262
University of Chicago Medical Center Chicago, Illinois  60637
Indiana University Simon Cancer Center Indianapolis, Indiana  46202
Dana Farber/Partners Cancer Care Boston, Massachusetts  02115