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

• Sponsor: CASI Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01104675
• Collaborator: (none)
• Enrollment: 64
• Locations: 6
• Arm: 1
• Duration (Months): 32
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer; Fallopian Cancer; Peritoneal Cancer	Drug: ENMD-2076	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Progression free survival rate [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
2	University of Chicago Medical Center	Chicago	Illinois	United States	60637
3	Indiana University Simon Cancer Center	Indianapolis	Indiana	United States	46202
4	Dana Farber/Partners Cancer Care	Boston	Massachusetts	United States	02115
5	Memorial Sloan-Kettering Cancer Center	New York	New York	United States
6	Princess Margaret Hospital	Toronto	Ontario	Canada

Sponsors and Collaborators

• CASI Pharmaceuticals, Inc.

Investigators

• Study Director: William Gannon, MD, MBA, CASI Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CASI Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01104675
• Other Study ID Numbers: 2076-CL-004
• First Posted: Apr 15, 2010
• Last Update Posted: Aug 6, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by CASI Pharmaceuticals, Inc.: ovarian; platinum resistant ovarian cancer
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Aug 6, 2014