A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma

NCT ID: NCT02178358

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-08
• Study Completion Date: 2021-02-18

Brief Summary

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY2157299 in participants with hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

150 milligram (mg) Galunisertib Monotherapy

150 mg galunisertib administered orally, twice daily (BID) for 14 days followed by 14 days with no study drug (28 days cycle).

Group Type: EXPERIMENTAL

LY2157299

Intervention Type: DRUG

Administered orally

150 mg Galunisertib + 400 mg Sorafenib Therapy

150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).

400 mg sorafenib administered orally BID for 28 days.

Group Type: EXPERIMENTAL

LY2157299

Intervention Type: DRUG

Administered orally

Sorafenib

Intervention Type: DRUG

Administered orally

400 mg Sorafenib + Placebo Therapy

Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle).

400 mg sorafenib administered orally BID for 28 days.

Group Type: PLACEBO_COMPARATOR

Sorafenib

Intervention Type: DRUG

Administered orally

Placebo

Intervention Type: DRUG

Administered orally

Interventions

LY2157299

Administered orally

Intervention Type: DRUG

Sorafenib

Administered orally

Intervention Type: DRUG

Placebo

Administered orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have histological evidence of a diagnosis of HCC not amenable to curative surgery.
• Have Child-Pugh Class A.
• Have the presence of measurable disease.
• Have adequate organ function.
• Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• If male or female with reproductive potential, must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
• If females with childbearing potential, must have had a negative serum pregnancy test 7 days prior to the first dose of study drug.
• Are able to swallow capsules or tablets.
• Have available diagnostic or biopsy tumor tissue.

Exclusion Criteria

• Have received previous systemic treatment for advanced disease.
• Have known HCC with fibro-lamellar or mixed histology.
• Have presence of clinically relevant ascites.
• Have had a liver transplant.
• Have moderate or severe cardiac disease.
• Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C virus infection.
• Have experienced Grade 3 or 4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion or endoscopic or operative intervention.
• Have esophageal or gastric varices that require immediate intervention or represent a high bleeding risk.
• Had major surgery within 4 weeks prior to the study randomization.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Beijing, , China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bengbu, , China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Changchun, , China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hangzhou, , China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hefei, , China

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hong Kong, , Hong Kong

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kowloon, , Hong Kong

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Incheon, , South Korea

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seoul, , South Korea

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Gwei Shan Township, , Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Liouying/Tainan, , Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Puzih City, , Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tainan City, , Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taipei, , Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taoyuan District, , Taiwan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bangkok, , Thailand

Countries

China; Hong Kong; South Korea; Taiwan; Thailand

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H9H-MC-JBAS

Identifier Type: OTHER

Identifier Source: secondary_id

15065

Identifier Type: -

Identifier Source: org_study_id