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

NCT01104675 | Completed Phase 2

• 1 other identifier: 2076-CL-004
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 6

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.

Conditions

Ovarian Cancer; Fallopian Cancer; Peritoneal Cancer

Keywords

ovarian; platinum resistant ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate

  6 months

Study Arms (1)

ENMD-2076 treatment

EXPERIMENTAL

Drug: ENMD-2076

Interventions

ENMD-2076 DRUG

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

ENMD-2076 treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (6)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Dana Farber/Partners Cancer Care

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

ENMD 2076

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• William Gannon, MD, MBA

  CASI Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

US (5); CA (1)