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Antimetabolite

Galunisertib + Chemotherapy for Rectal Cancer

Phase 2

Waitlist Available

Led By Kristina Young, MD, PhD

Research Sponsored by Providence Health & Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically confirmed rectal adenocarcinoma, AJCC Stage IIA-IIIC or AJCC Stage IV appropriate for consideration of primary rectal tumor resection

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Must not have

History of cardiac disease

Concomitant use of strong CYP3A4 inhibitors and inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients should be evaluated for response at surgery and every 3 months for 2 years and then every 6 months at year three and four. all patients will be followed for survival until death or 5 years post-treatment (whichever comes first)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to treat rectal cancer in combination with chemotherapy and radiation. Tissue and blood samples will also be collected to study the effectiveness of the drug and the immune system's response.

Who is the study for?

Adults with confirmed rectal adenocarcinoma stages IIA-IIIC or stage IV suitable for tumor removal can join. They must be in good enough health to undergo treatment, not have serious heart conditions, active infections, autoimmune diseases, or a recent history of other cancers. Participants should not be pregnant and must use approved contraception.

What is being tested?

The ExIST study is testing the safety and effectiveness of LY2157299 combined with chemotherapy (Fluorouracil or Capecitabine) and radiation therapy in treating rectal cancer over an 8-week period. The trial will also analyze tumor and blood samples to predict treatment response.

What are the potential side effects?

Possible side effects include reactions related to the immune system due to LY2157299, typical chemotherapy-related issues like nausea, fatigue, low blood counts leading to increased infection risk, as well as potential impacts from radiation such as skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My rectal cancer is confirmed and considered for surgery.

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I am able to get out of my bed or chair and move around.

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I am not currently experiencing any bleeding.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of heart disease.

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I am not taking strong CYP3A4 inhibitors or inducers.

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I have an aortic aneurysm.

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I have a weak immune system or need medication that affects my immune system.

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I am currently on antibiotics for an infection.

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I have had radiation therapy to my pelvic area before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients should be evaluated for response at surgery and every 3 months for 2 years and then every 6 months at year three and four. all patients will be followed for survival until death or 5 years post-treatment (whichever comes first)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients should be evaluated for response at surgery and every 3 months for 2 years and then every 6 months at year three and four. all patients will be followed for survival until death or 5 years post-treatment (whichever comes first)

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients should be evaluated for response at surgery and every 3 months for 2 years and then every 6 months at year three and four. all patients will be followed for survival until death or 5 years post-treatment (whichever comes first) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluation of pathologic response

Secondary study objectives

Immunologic monitoring parameters

Immunoscore (utilizing tumor tissue)

MRI Parameters

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LY2157299 + Chemoradiation + SurgeryExperimental Treatment4 Interventions

Patients will receive a 14 day course of LY2157299. On day 15 patients will begin chemoradiation treatment with Capecitabine or Fluorouracil. On day 29, patients will undergo another fourteen day course of LY2157299 concurrent with their ongoing chemoradiation treatment. Six to ten weeks after completing their neoadjuvant therapy, patient will undergo a tumor specific mesorectal excision as per standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY2157299

2011

Completed Phase 2

~520

Fluorouracil

2014

Completed Phase 3

~11700