Back to resultsStudy of Oral ENMD-2076 Administered to Patients With Ovarian Cancer
Primary Purpose
Ovarian Cancer, Fallopian Cancer, Peritoneal Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ENMD-2076
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian, platinum resistant ovarian cancer
Eligibility 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
Sites / Locations
- University of Colorado Cancer Center
- University of Chicago Medical Center
- Indiana University Simon Cancer Center
- Dana Farber/Partners Cancer Care
- Memorial Sloan-Kettering Cancer Center
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ENMD-2076 treatment
Arm Description
Outcomes
Primary Outcome Measures
Progression free survival rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01104675
First Posted
April 14, 2010
Last Updated
August 4, 2014
Sponsor
CASI Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01104675
Brief Title
Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer
Official Title
A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CASI Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Cancer, Peritoneal Cancer
Keywords
ovarian, platinum resistant ovarian cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ENMD-2076 treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ENMD-2076
Intervention Description
275 mg (or 250 mg for BSA < 1.65) per day in oral capsules in 28 day continuous cycles
Primary Outcome Measure Information:
Title
Progression free survival rate
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Gannon, MD, MBA
Organizational Affiliation
CASI Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dana Farber/Partners Cancer Care
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer
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