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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01104675
First received: April 14, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Ovarian Cancer
Fallopian Cancer
Peritoneal Cancer
Drug: ENMD-2076
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by CASI Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression free survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: April 2010
Study Completion Date: December 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: CASI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01104675     History of Changes
Other Study ID Numbers: 2076-CL-004
Study First Received: April 14, 2010
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 18, 2014