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ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer

NCT02688712 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to see how effective and safe LY2157299, in combination with chemotherapy and radiation therapy, might be in treating rectal cancer. Also as part of this study, research will be done on tumor samples to see if it is possible to predict if patients will respond to treatment, and blood samples to look at the immune system response to study treatment.

About 50 people will take part in this study. The study treatment will be given over an 8 week period and the investigators will continue to collect your health information for up to 5 years, as part of this study

Conditions

  • Rectal Adenocarcinoma

Interventions

DRUG

LY2157299

Small molecule inhibitor of transforming growth factor-beta signaling pathway

DRUG

Capecitabine

Antimetabolite chemotherapy

DRUG

Fluorouracil

Antimetabolite chemotherapy

PROCEDURE

Tumor specific mesorectal excision

Tumor specific mesorectal excision

Sponsors & Collaborators

Principal Investigators

  • Kristina Young, MD, PhD · Providence Health & Services

  • Todd Crocenzi, MD · Providence Health & Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-24
Primary Completion
2026-01-26
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02688712 on ClinicalTrials.gov