ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer

Phase 2 Active not recruiting 50 enrolled Providence Health & Services Eli Lilly and Company · collab

NaSingle-groupOpen-labelTreatment

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

Timeline

Start: 2016-03-24
Primary completion: 2026-01-26
Completion: 2026-12

Outcome

Met primary endpoint

paper In total, 12 (32% [one-sided 95% CI ≥19%]) of 38 patients had a complete response. PMID 35952709 ↗

paper The addition of galunisertib to neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer improved the complete response rate to 32%, was well tolerated, and warrants further assessment in randomised trials. PMID 35952709 ↗

Publications

Yamazaki T, Gunderson AJ, Gilchrist M, Whiteford M, Kiely MX, Hayman A, O'Brien D, Ahmad R, Manchio JV, Fox N, McCarty K, Phillips M, Brosnan E, Vaccaro G, Li R, Simon M, Bernstein E, McCormick M, Yamasaki L, Wu Y, Drokin A, Carnahan T, To Y, Redmond WL, Lee B, Louie J, Hansen E, Solhjem MC, Cramer J, Urba WJ, Gough MJ, Crittenden MR, Young KH. Galunisertib plus neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer: a single-arm, phase 2 trial. Lancet Oncol. 2022 Sep;23(9):1189-1200. doi: 10.1016/S1470-2045(22)00446-6. Epub 2022 Aug 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Galunisertib	Small molecule	150 mg	Oral
Background	Capecitabine	Small molecule	825 mg/m2	Oral
Background	Capecitabine	Small molecule	1000 mg/m2	Oral
Background	fluorouracil	Small molecule	225 mg/m2	Intravenous
Background	fluorouracil	Small molecule	400 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2400 mg/m2	Intravenous