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

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

Inclusion Criteria

Histological or cytological diagnosis of ductal adenocarcinoma of the pancreas.

Metastatic disease with documented disease progression following previous treatment with at least one, but no more than 2 prior therapies, with one of the prior therapies having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant and/or adjuvant therapies for localized resectable or unresectable PDAC each count as a line of therapy if multiagent chemotherapy regimens were administered (and neoadjuvant regimen was different than adjuvant regimen) and if the participant progressed with metastatic disease while taking or within 6 months of completion of (neo)adjuvant therapy.

Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

See 6 more

Treatment Details

Interventions

Abemaciclib (CDK4/6 Inhibitor)
Capecitabine (Anti-metabolites)
Gemcitabine (Anti-metabolites)
LY3023414 (Other)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Standard of Care (Gemcitabine or Capecitabine)Experimental Treatment2 Interventions

Gemcitabine given intravenously (IV) OR capecitabine given orally.

Group II: Abemaciclib + LY3023414Experimental Treatment2 Interventions

Abemaciclib given orally and LY3023414 given orally.

Group III: AbemaciclibExperimental Treatment1 Intervention

Abemaciclib given orally.

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Verzenio for:

Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for: