ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer

Sponsor: Providence Health & Services

Sponsor score: 40

ClinicalTrials ID:NCT02688712

Provider View

This clinical trial is testing a new treatment, LY2157299, combined with chemotherapy and radiation, to see if it can effectively treat rectal cancer. Researchers will also study tumor and blood samples to understand how patients respond to the treatment.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of LY2157299 when used with chemotherapy and radiation therapy for treating rectal cancer. Researchers will also analyze tumor samples to predict treatment response and blood samples to assess immune system reactions. About 50 participants will be involved, receiving treatment over 8 weeks, with health monitoring continuing for up to 5 years.

Description

This Phase II study is testing LY2157299 with chemotherapy and radiation in patients with rectal adenocarcinoma. The goal is to see if LY2157299 can improve immune cell activity in tumors, leading to better treatment outcomes. Researchers hope this will result in longer survival without disease and overall survival.

The main objectives are:

  1. To determine how well patients with advanced rectal cancer respond to the treatment.
  2. To study changes in immune markers before, during, and after treatment.
  3. To monitor immune responses to identify potential indicators of treatment success.

Eligible patients will have confirmed rectal adenocarcinoma and will undergo a biopsy and MRI for diagnosis. Participants will receive LY2157299 for 14 days, followed by another biopsy and MRI. Then, they will start chemotherapy with either 5-FU or capecitabine, along with radiation therapy. After 14 more days of LY2157299, patients will continue with chemoradiation. Radiation will be given in daily doses over 28-30 sessions, lasting up to 8 weeks. Six to ten weeks after completing treatment, patients will have surgery to remove the tumor and assess the treatment's effectiveness. Patients will be monitored for survival and recurrence. A safety check will be done with the first three patients before enrolling more participants.

Eligibility Criteria

Inclusion Criteria

  • Adults (18+) with confirmed rectal adenocarcinoma, suitable for surgery.
  • Good overall health (ECOG status 0-2).
  • Specific blood test results within normal ranges.
  • Women must not be pregnant and must use contraception during and after treatment. Men must also avoid fathering a child during and after treatment.
  • No active bleeding.
  • Ability to understand and consent to the study.

Exclusion Criteria

  • Active infections needing antibiotics.
  • Autoimmune diseases.
  • Recent history of other cancers (except certain skin cancers).
  • Previous pelvic radiation.
  • Heart conditions or risk factors for aneurysms.
  • Need for immunosuppressive drugs or steroids.
  • Recent participation in other drug studies.
  • Pregnant or breastfeeding women.
  • Other medical or psychiatric conditions that could affect safety.
  • Use of certain medications that affect drug metabolism.

Locations

FACILITYZIPCITYSTATE
Providence Cancer Center97213PortlandOregon

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.