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An Open-Label Multicenter Phase 1b Study of E7046 in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Subjects With Rectum Cancer

Clinical Trial Details

This clinical trial is for men and women age ≥ 18 years old who have been diagnosed with advanced rectum cancer. This is a phase 1b study to assess the safety and tolerability of the investigational study drug, E7046, which is manufactured by Eisai Inc., in combination with preoperative radiotherapy and chemotherapy in the short course and long course radiotherapy settings. E7046 is an investigational drug being developed by the Sponsor, Eisai Inc., and is thought to work by allowing your immune system to better fight cancer.

If you choose to participate in the study you will receive either [A] Long Course Chemo-Radiotherapy (LCRT) in combination with E7046 OR [B] Short Course Radiotherapy followed by chemotherapy (SCRT) in combination with E7046. 

   • You will then receive surgery approximately 4-6 weeks after the completion of the study drug.
   • Your participation in the study will last up to 16 weeks of treatment, follow by a 2 year follow up period
   • Extensive safety evaluations will be made each week of your treatment
   • You will continue on treatment as long as you are responding to therapy and not experiencing unacceptable side effects.

Key Eligibility: 

   • Open to men and women, Age ≥18 years at the time of informed consent who have been diagnosed with invasive primary rectal cancer
   • No prior pelvic radiotherapy, chemotherapy, immunotherapy or other anti-cancer treatment for rectal cancer
   • Ability to read and provide signed informed consent. Patients may not be consented by a durable power of attorney.
   • Ability and willingness to comply with scheduled study visits, treatment plans, laboratory tests and other study related procedures 

Additional eligibility criteria reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Sharanya Chandrasekhar
(646) 962-2196
shc2043@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1612017834

ClinicalTrials.gov:

NCT03152370

Status

Open to Enrollment

Age Group

Adult

Sponsor