Bristol-Myers Squibb Dasatinib Src Inhibition in Endometrial Cancer

Completed · Early Phase 1

Conditions studied: Endometrial Cancer

In brief

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 is a drug that blocks the activity of an important protein in cancer cells called Src. The investigators can measure the blocking of Src in the bloodstream. However, the investigators do not know if measures in the bloodstream reflect blockage of Src in cancer tissue. The investigators are doing this study to try and see if the investigators can match what the investigators see in cancer tissue to what the investigators see in the bloodstream. the investigators hope that in the future, the investigators can use blood to measure protein inhibition by dasatinib instead of asking patients to undergo repeat biopsies.

Key facts

Study ID

NCT01482728

Run by

University of Virginia

People needed

12

Starts

2012-01-01

Expected to finish

2015-12-01

Last updated by the study team

2016-05-13

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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