New drug combo aims to wipe out rectal tumors before surgery
NCT ID NCT02688712
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding the experimental drug galunisertib to standard chemoradiation can improve outcomes for people with locally advanced rectal cancer. About 50 participants will receive the combination over 8 weeks, followed by surgery. Researchers will also study tumor and blood samples to understand who responds and how the immune system reacts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Galunisertib (LY2157299)
- What this could lead to
- If successful, this could lead to a more effective treatment for locally advanced rectal cancer, potentially improving the chance of a complete tumor response before surgery.
- What could go wrong
- This is a small, early-phase trial (50 people) and the drug is experimental. It may not work better than standard treatment, and side effects from combining it with chemoradiation are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2016
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients (male and female) 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 * Age 18 years or above. * Laboratory values (performed within 28 days prior to enrollment) as follows: * WBC ≥3.0 109/L * Hgb ≥9g/dl (patients may be transfused to reach this level) * Platelets ≥99 109 /L * Creatinine ≤1.5X upper limit of laboratory normal * AST/ALT ≤5 X upper limit of laboratory normal * Total bilirubin ≤1.5X upper limit of laboratory normal * BNP ≤ 3 times the baseline value and upper limit of laboratory normal * Troponin I ≤ upper limit of laboratory normal * hsCRP ≤ upper limit of laboratory normal * Cystatin ≤ upper limit of laboratory normal * PT/INR ≤1.5X upper limit of laboratory normal * Pre-menopausal women must have a negative pregnancy test on the day treatment starts and must avoid becoming pregnant while on treatment and for 3 months following completion of therapy. Men must avoid fathering a child while on treatment and for 3 months following completion of therapy. This exclusion is required due to the toxicities that chemotherapy, radiation, and LY2157299 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may alter immune function it may limit the treatment efficacy. Women of childbearing potential must agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of LY2157299. Contraceptive methods may include an intrauterine device \[IUD\], birth control pills or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. * No active bleeding. * Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. Exclusion Criteria: * Active infection requiring systemic antibiotics. * Active autoimmune disease as defined by the autoimmune disease assessment tool (see protocol) * Diagnosis of a solid tumor malignancy (excluding non-melanoma skin cancer) within 3 years of enrollment. * History of prior pelvic radiation. * Aortic aneurysm (see protocol) * Abnormal Echocardiogram (see protocol) * Immunodeficiency, need for immunosuppressive medications, or need for chronic steroids. * Participation in any investigational drug study within 28 days of enrollment. * Pregnant or lactating women, as treatment involves risks to the embryo or fetus. * Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol. * History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart. * Concomitant use of strong CYP3A4 inhibitors and inducers
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Providence Cancer Center
Portland, Oregon, 97213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New injectable drug tested against Hard-to-Treat solid tumors
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- Can Pre-Surgery radiation stop rectal cancer from returning?