A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

Phase 2 Completed 106 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

Timeline

Start: 2017-01-12
Primary completion: 2018-04-20
Completion: 2018-11-09

Outcome

Missed primary endpoint

paper In patients with pretreated metastatic PDAC, abemaciclib-based therapy did not improve DCRs or PFS compared with SOC chemotherapy. PMID 37840530 ↗

Publications

Chiorean EG, Picozzi V, Li CP, Peeters M, Maurel J, Singh J, Golan T, Blanc JF, Chapman SC, Hussain AM, Johnston EL, Hochster HS. Efficacy and safety of abemaciclib alone and with PI3K/mTOR inhibitor LY3023414 or galunisertib versus chemotherapy in previously treated metastatic pancreatic adenocarcinoma: A randomized controlled trial. Cancer Med. 2023 Oct;12(20):20353-20364. doi: 10.1002/cam4.6621. Epub 2023 Oct 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abemaciclib	Small molecule	—	Oral
Subject	Capecitabine	Small molecule	—	Oral
Subject	Gemcitabine	Small molecule	—	Intravenous
Subject	Samotolisib	Small molecule	—	Oral