Status:
COMPLETED
Bristol-Myers Squibb Dasatinib Src Inhibition in Endometrial Cancer
Lead Sponsor:
University of Virginia
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-90 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to see if the investigators can measure inhibition of a protein, Src (named for Sarcoma), in tissue and blood in patients with a diagnosis of endometrial cancer. Dasatinib...
Detailed Description
Endometrial cancer is the most common of the gynecologic malignancies; affecting 42,160 women in the US in 2009.1 In addition it is often a hormonally driven tumor, expressing in many cases both estro...
Eligibility Criteria
Inclusion
- Women age 18 and older
- Newly diagnosed primary histologically documented endometrioid adenocarcinoma of the endometrium that is being treated surgically with hysterectomy and BSO
- Performance status 0-1
- Agree to pre operative biopsy
- Adequate organ function
- Ability to take oral medication
- Negative serum pregnancy test
Exclusion
- Prior therapy with dasatinib or any other anti-src drug
- Women with positive pregnancy test
- Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s)
- Prisoners or subjects who are involuntarily incarcerated
- Histologic subtypes of endometrial cancer other than endometrioid
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- History of significant bleeding disorder unrelated to cancer
- No previous history of malignancy which required radiotherapy or systemic treatment within the past 5 years
- Pleural or pericardial effusion of any grade
- Cardiac symptoms including but not limited to angina, prolonged QTc interval, significant ventricular arrhythmia
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01482728
Start Date
January 1 2012
End Date
December 1 2015
Last Update
May 13 2016
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908