NCT04071262

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 20, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 15, 2021

Enrollment Period

1.2 years

First QC Date

August 26, 2019

Last Update Submit

September 20, 2021

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Dose Limiting Toxicities (DLTs)

    Number of Participants with DLTs

    Baseline through Cycle 1 (28 Day Cycle)

Secondary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone

    Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)

  • PK: Maximum Concentration (Cmax) of Abemaciclib in Combination with Abiraterone Acetate plus Prednisolone

    Predose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles)

Study Arms (1)

Abemaciclib + Abiraterone Acetate + Prednisolone

EXPERIMENTAL

Abemaciclib, abiraterone acetate and prednisolone given orally.

Drug: AbemaciclibDrug: Abiraterone AcetateDrug: Prednisolone

Interventions

AbemaciclibDRUG

Administered orally

Also known as: LY2835219
Abemaciclib + Abiraterone Acetate + Prednisolone
Abiraterone AcetateDRUG

Administered orally

Abemaciclib + Abiraterone Acetate + Prednisolone
PrednisoloneDRUG

Administered orally

Abemaciclib + Abiraterone Acetate + Prednisolone

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Center Hospital East

Kashiwa, Chiba, 277 8577, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

Location

MeSH Terms

Interventions

abemaciclibAbiraterone AcetatePrednisolone

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsPregnadienesPregnanes

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

December 20, 2019

Primary Completion

February 12, 2021

Study Completion

August 30, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09-15

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)