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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071262
• Other study ID #: 17229
• Secondary ID: I3Y-JE-JPCQ
• Status: Completed
• Phase: Phase 1
• Start date: December 20, 2019
• Est. completion date: August 30, 2021

Study information

• Verified date: September 15, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 30, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• Abemaciclib
Administered orally
• Abiraterone Acetate
Administered orally
• Prednisolone
Administered orally

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicities (DLTs)	Number of Participants with DLTs	Baseline through Cycle 1 (28 Day Cycle)
Secondary	Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone	PK: AUC of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone	Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)
Secondary	PK: Maximum Concentration (Cmax) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone	PK: Cmax of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone	Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)