Trial Outcomes & Findings for The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer (NCT NCT00619242)

Results Overview

Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

Two weeks

Results posted on

2014-03-12

Participant Flow

The study was activated and opened to accrual 06/19/2006. the study was terminated 7/17/2009. Subjects were seen in the University of Chicago outpatient clinics.

Subjects must have histologically confirmed Barrett's esophagus with high-grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS) on prior endoscopy within the previous 12 months.

Participant milestones

Participant milestones
Measure	Sorafenib Sorafenib 400mg BID
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib n=3 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Two weeks

Population: The 3 subjects underwent therapy without complications however the study was terminated due to low accrual.

Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.

Outcome measures

Outcome data not reported

Adverse Events

Sorafenib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ezra Cohen, MD

The University of Chicago

Phone: 773/702-4137

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place