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CompletedNCT01104675Updated Aug 6, 2014

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

A Phase 2 interventional study of ENMD-2076 in Ovarian Cancer, Fallopian Cancer and Peritoneal Cancer, sponsored by CASI Pharmaceuticals, Inc.. Completed at 6 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-06.

Sponsored by CASI Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Ovarian Cancer
  • Fallopian Cancer
  • Peritoneal Cancer

Keywords

  • ovarian
  • platinum resistant ovarian cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 64 is close to the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

CASI Pharmaceuticals, Inc. is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    ENMD-2076 treatment

    Drug: ENMD-2076

Interventions

  • DrugENMD-2076

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

06

What researchers measure

Primary outcomes

  1. Progression free survival rate

    Time frame: 6 months

07

Study locations

6 sites
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Indiana University Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • Dana Farber/Partners Cancer Care
    Boston, Massachusetts 02115, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York, United States
  • Princess Margaret Hospital
    Toronto, Ontario, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01104675
Lead sponsor
CASI Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Apr 15, 2010
Start date
Apr 2010
Primary completion
Aug 2011
Completion
Dec 2012
Last update
Aug 6, 2014

Study contacts

William Gannon, MD, MBA
study director · CASI Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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