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Completed

NCT Number: NCT04071262

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

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abemaciclib

Drug

Administered orally

Other names: LY2835219

Abiraterone Acetate

Drug

Administered orally

Prednisolone

Drug

Administered orally

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: Baseline through Cycle 1 (28 Day Cycle)

    Number of Participants with DLTs

Secondary outcomes

  1. 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)

    PK: AUC of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone

  2. 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)

    PK: Cmax of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1 Study of Abemaciclib in Combination With Other Anti-Cancer Therapy in Japanese Patients With Advanced Cancer

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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