Study of ENMD-2076 in Patients With Advanced/Metastatic Soft Tissue Sarcoma
Verified June 2013 by University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
First received: October 30, 2012
Last updated: June 27, 2013
Last verified: June 2013
This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma. This study will help to understand how well ENMD-2076 works and how safe and tolerable the drug is in this patient population.
Soft Tissue Sarcoma
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Oral ENMD-2076 Administered to Patients With Advanced/Metastatic Soft Tissue Sarcoma
Primary Outcome Measures:
- Number of patients with no progression of disease at 6 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
ENMD-2076 capsules, 275 mg once daily, by mouth.
ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Women who are pregnant or nursing
- Have active, acute, or chronic clinically significant infections or bleeding.
- Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); or history of congestive heart failure (equal to or greater than Grade 2 classification by New York Heath Association).
- Have active angina pectoris, stroke or recent myocardial infarction (within 6 months).
- Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 480 msec.
- Have additional uncontrolled serious medical or psychiatric illness.
- Require therapeutic doses of anti-coagulation either by virtue of low-molecular weight heparin or coumadin (prophylactic anti-coagulation allowed). Patients with previous history of deep venous thrombosis or pulmonary embolism are also excluded.
- Known CNS metastases
- Have any medical condition that would impair the administration of oral agents including recurrent bowel obstructions, inflammatory bowel disease or uncontrolled nausea, vomiting or diarrhea
- Have 2+ protein by urinalysis. Patients with an ongoing or previous history of nephrotic syndrome will be excluded
- Have an additional malignancy diagnosed within 5 years of study enrollment with the exception of basal or squamous cell skin cancer or cervical cancer in situ
- Require treatment with drugs known to be potent inducers or inhibitors of CYP3A4 that cannot be substituted
- Patients who cannot or refuse to stop herbal medications of illicit drug use will be excluded from the study. Use of medical marijuana is not permissible in this study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719744
|Princess Margaret Cancer Centre
|Toronto, Ontario, Canada, M5G 2M9 |
|Principal Investigator: Malcolm Moore, M.D. |
|Sub-Investigator: Albiruni Razak, M.D. |
University Health Network, Toronto
||Malcolm Moore, M.D.
||Princess Margaret Cancer Centre
No publications provided
||University Health Network, Toronto
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 30, 2012
||June 27, 2013
||Canada: Health Canada
Canada: Ethics Review Committee
Keywords provided by University Health Network, Toronto:
soft tissue sarcoma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2014
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue