Selinexor Combined With Standard Chemoradiation as Neoadjuvant Treatment in Locally Advanced Rectal Cancer

PHASE1UnknownINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

June 30, 2017

Study Completion Date

September 30, 2017

Conditions
Rectal Neoplasms
Interventions
RADIATION

standard dose pelvic radiation therapy

"radiation therapy to pelvis delivered using standard conformal or IMRT techniques.~50.4-55 Gy"

DRUG

standard dose capecitabine

825 mg/m2 twice daily, 5 days a week (max dose 2000mg twice daily), only on days when radiation is delivered

DRUG

dose-escalated selinexor treatment

Selinexor oral drug will be given twice weekly according to the dose escalation schedule described in the protocol. Selinexor will be started on the day radiation begins, until the end of week 6.

Trial Locations (1)

52621

RECRUITING

Sheba Medical Center, Ramat Gan

Sponsors
All Listed Sponsors
collaborator

Karyopharm Therapeutics Inc

INDUSTRY

lead

Sheba Medical Center

OTHER_GOV