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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Cancer, Peritoneal Cancer

Thank you

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:

Interventional

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:

No

Principal Investigator

Carolyn Sidor, MD, MBA

Investigator Role:

Study Director

Investigator Affiliation:

EntreMed

Authority:

United States: Food and Drug Administration

Study ID:

2076-CL-004

NCT ID:

NCT01104675

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Colorado Cancer CenterDenver, Colorado  80262
University of Chicago Medical CenterChicago, Illinois  60637
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Dana Farber/Partners Cancer CareBoston, Massachusetts  02115