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An Open-Label Multicenter Phase 1b Study of E7046 in Combination with Radiotherapy/ Chemo radiotherapy (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, in combination with preoperative radiotherapy and chemotherapy in the short course and long course radiotherapy settings. The primary objective of this study is to find a safe dose level of the investigational study drug, E7046 in combination with radiotherapy and chemotherapy. Other objectives of the study are to determine the maximum tolerated dose and/or recommended phase 2 dose of E7046 in combination with preoperative radiotherapy and chemotherapy. Currently available treatments are effective in some patients but many experience side effects. Therefore, there is a need to find more effective treatments with fewer side effects. 

Key Eligibility: 
  • This trial is open to men and women ages 18 and up 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 is acceptable. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Sally Sa
(646) 697-0369
sas9126@med.cornell.edu

Primary Investigator(s)

John Ng  (UES)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1612017834

ClinicalTrials.gov:

NCT03152370

Status

Open to Enrollment

Age Group

Adult

Sponsor