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Completed

NCT Number: NCT01104675

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENMD-2076

Drug

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

Primary outcomes

  1. Progression free survival rate

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

CASI pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 15, 2010
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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