Clinical Trials /

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer

NCT04071262

Description:

The purpose of this study is to see if the study drug abemaciclib in combination with other anti-cancer therapies is safe in Japanese participants with advanced cancer.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Therapies in Japanese Participants With Advanced Cancer
  • Official Title: A Phase 1 Study of Abemaciclib in Combination With Other Anti-Cancer Therapy in Japanese Patients With Advanced Cancer

Clinical Trial IDs

  • ORG STUDY ID: 17229
  • SECONDARY ID: I3Y-JE-JPCQ
  • NCT ID: NCT04071262

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
AbemaciclibLY2835219Abemaciclib + Abiraterone Acetate + Prednisolone
Abiraterone AcetateAbemaciclib + Abiraterone Acetate + Prednisolone
PrednisoloneAbemaciclib + Abiraterone Acetate + Prednisolone

Purpose

The purpose of this study is to see if the study drug abemaciclib in combination with other anti-cancer therapies is safe in Japanese participants with advanced cancer.

Trial Arms

NameTypeDescriptionInterventions
Abemaciclib + Abiraterone Acetate + PrednisoloneExperimentalAbemaciclib, abiraterone acetate and prednisolone given orally.
  • Abemaciclib
  • Abiraterone Acetate
  • Prednisolone

Eligibility Criteria

        Inclusion Criteria:

          -  Participant with histologically confirmed adenocarcinoma of the prostate.

          -  Participant with metastatic disease documented by positive bone scan and/or measurable
             soft tissue metastatic lesions by computed tomography (CT) or magnetic resonance
             imagining (MRI).

          -  Participant who has serum testosterone level is ≤1.73 nanomoles per liter (nmol/L) (50
             nanograms per deciliter).

          -  Participant who has progressive disease at study entry demonstrated during continuous
             androgen-deprivation therapy (ADT)/post orchiectomy.

          -  Participant with adequate organ function.

          -  Participant with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

        Exclusion Criteria:

          -  Participant who was treated with cytochrome P450 (CYP)17 inhibitors (including
             abiraterone acetate, TAK-700, TOK-001, and ketoconazole).

          -  Participant who was treated with abemaciclib or any cyclin dependent kinase 4 and 6
             (CDK4 and 6) inhibitors.

          -  Participant who has prior cytotoxic chemotherapy for metastatic castration-resistant
             prostate cancer (mCRPC), prior radiopharmaceuticals for prostate cancer (PCa), or
             prior sipuleucel-T.

          -  Participant who has gastrointestinal disorder affecting absorption or inability to
             swallow large pills.

          -  Participant who has clinically active or chronic liver disease, moderate/severe
             hepatic impairment, ascites, or bleeding disorders secondary to hepatic dysfunction.

          -  Participant who has known or suspected central nervous system metastatic disease.

          -  Participant who was treated with drugs known to be strong inhibitors, or strong or
             moderate inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be
             discontinued or switched prior to starting study treatment.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame:Baseline through Cycle 1 (28 Day Cycle)
Safety Issue:
Description:Number of Participants with DLTs

Secondary Outcome Measures

Measure:Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: AUC of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone
Measure:PK: Maximum Concentration (Cmax) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone
Time Frame:Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)
Safety Issue:
Description:PK: Cmax of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

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