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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2021-08-30

Brief Summary

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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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Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abemaciclib + Abiraterone Acetate + Prednisolone

Abemaciclib, abiraterone acetate and prednisolone given orally.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally

Abiraterone Acetate

Intervention Type DRUG

Administered orally

Prednisolone

Intervention Type DRUG

Administered orally

Interventions

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Abemaciclib

Administered orally

Intervention Type DRUG

Abiraterone Acetate

Administered orally

Intervention Type DRUG

Prednisolone

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2835219

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No