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

NCT ID: NCT01104675

Last Updated: 2014-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer Fallopian Cancer Peritoneal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ENMD-2076 treatment

Group Type EXPERIMENTAL

ENMD-2076

Intervention Type DRUG

275 mg (or 250 mg for BSA \< 1.65) per day in oral capsules in 28 day continuous cycles

Interventions

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ENMD-2076

275 mg (or 250 mg for BSA \< 1.65) per day in oral capsules in 28 day continuous cycles

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CASI Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Gannon, MD, MBA

Role: STUDY_DIRECTOR

CASI Pharmaceuticals, Inc.

Locations

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University of Colorado Cancer Center

Aurora, Colorado, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Dana Farber/Partners Cancer Care

Boston, Massachusetts, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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2076-CL-004

Identifier Type: -

Identifier Source: org_study_id

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