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

Sponsor
Sheba Medical Center
Study ID
NCT02137356
Phase
PHASE1
Status
Unknown

Conditions

  • Rectal Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • standard dose pelvic radiation therapy — RADIATION
    radiation therapy to pelvis delivered using standard conformal or IMRT techniques. 50.4-55 Gy
  • standard dose capecitabine — DRUG
    825 mg/m2 twice daily, 5 days a week (max dose 2000mg twice daily), only on days when radiation is delivered
  • dose-escalated selinexor treatment — DRUG
    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.

Study Details

Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This treatment is associated with only a 15-20% pathological complete response. Selinexor (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has demonstrated radiosensitization with in vivo models and has suggested single agent activity against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard chemoradiation combined with Selinexor. We hypothesize that tumors treated with this new combination will demonstrate an increased response rate compared to those treated with capecitabine-radiation alone.

Key Dates

Start date
Dec 31, 2014
Status verified
Sep 2015
Primary completion
Jun 30, 2017
Completion
Sep 30, 2017

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment arm
    standard dose pelvic radiation therapy, standard dose capecitabine, dose-escalated selinexor treatment

Primary Outcome Measure

Number of patients with adverse events [ Time Frame: Six weeks ]

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