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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01104675
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
CASI Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Cancer Peritoneal Cancer Drug: ENMD-2076 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer
Study Start Date : April 2010
Primary Completion Date : August 2011
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ENMD-2076 treatment Drug: ENMD-2076
275 mg (or 250 mg for BSA < 1.65) per day in oral capsules in 28 day continuous cycles



Primary Outcome Measures :
  1. Progression free survival rate [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104675


Locations
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Dana Farber/Partners Cancer Care
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
Investigators
Study Director: William Gannon, MD, MBA CASI Pharmaceuticals, Inc.

Responsible Party: CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01104675     History of Changes
Other Study ID Numbers: 2076-CL-004
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

Keywords provided by CASI Pharmaceuticals, Inc.:
ovarian
platinum resistant ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders