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NCT01104675 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01104675
Other study ID # 2076-CL-004
Secondary ID
Status Completed
Phase Phase 2
First received April 14, 2010
Last updated August 4, 2014
Start date April 2010
Est. completion date December 2012

Study information
Verified date August 2014
Source CASI Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date December 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ENMD-2076
275 mg (or 250 mg for BSA < 1.65) per day in oral capsules in 28 day continuous cycles

Locations
Country Name City State
Canada Princess Margaret Hospital Toronto Ontario
United States University of Colorado Cancer Center Aurora Colorado
United States Dana Farber/Partners Cancer Care Boston Massachusetts
United States University of Chicago Medical Center Chicago Illinois
United States Indiana University Simon Cancer Center Indianapolis Indiana
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
CASI Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression free survival rate 6 months
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