A Study of LY2157299 in Participants With Unresectable Hepatocellular Cancer (HCC)

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase 1b Study of LY2157299 in Combination With Sorafenib in Patients With Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240433
• Other study ID #: 14856
• Secondary ID: H9H-JE-JBAP
• Status: Completed
• Phase: Phase 1
• Start date: November 12, 2014
• Est. completion date: December 25, 2019

Study information

• Verified date: February 1, 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate safety and tolerability of LY2157299 when combined with sorafenib in Japanese hepatocellular carcinoma (HCC) participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 25, 2019
• Est. primary completion date: July 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Have histological evidence of a diagnosis of HCC (except HCC with fibrolamellar or mixed histology) not amenable to curative surgery.

• Have Child-Pugh Class A.

• Have the presence of measurable or evaluable lesion as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A measurable or evaluable lesion showing demonstrable progression after locoregional therapy could be also included.

• Have not received sorafenib prior to enrollment.

• Have resolution to Grade less than or equal 1 by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 of all clinically significant toxic effects of prior locoregional therapy, surgery, chemoembolization, systemic chemotherapy.

• Have a performance status of less than or equal 1 on the Eastern Cooperative Oncology Group (ECOG) scale.

Exclusion Criteria:

• Are currently enrolled, or discontinued within 28 days prior to enrollment from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

• Have undergone major surgery within 28 days prior to enrollment.

• Have undergone hepatic locoregional therapy (including radiation, surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, cryoablation, percutaneous ethanol injection, or percutaneous microwave coagulation therapy) within 28 days prior to enrollment.

• Have moderate or severe cardiac disease.

• Myocardial infarction within 6 months prior to enrollment, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension.

• Documented major electrocardiogram (ECG) abnormalities at the investigator's discretion within 28 days prior to enrollment.

• Major abnormalities documented by echocardiography with Doppler at investigator's direction within 28 days prior to enrollment.

• Have persistently elevated brain natriuretic peptide (BNP) or elevated troponin I within 14 days prior to enrollment.

• Predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress.

• Have a history of cardiac or aortic surgery.

• Have undergone liver transplant.

• Are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• LY2157299
LY2157299 administered orally
• Sorafenib
Sorafenib administered orally

Locations

Country	Name	City	State
Japan	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.	Chiba
Japan	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.	Kanagawa
Japan	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.	Suita-shi

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 LY2157299 Dose-Limiting Toxicities (DLT)		Cycle 1 (28 days)
Secondary	Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve (AUC) of LY2157299		Cycle 1 Day1: predose through 6 hours post dose; Cycle1 Day14: predose through 24 hours post dose
Secondary	PK: Maximum Observed Plasma Concentration (Cmax) of LY2157299		Cycle 1 Day 1: Predose through 6 hours post dose; Cycle 1 Day 14: Predose through 24 hours post dose
Secondary	Time to Progression (TTP)		Baseline to objective progressive disease (estimated as 6 months)
Secondary	Progression-free Survival (PFS)		Baseline to objective progressive disease or death (estimated as 6 months)
Secondary	The Number of Participants with Best Response of Partial Response (PR), Complete Response (CR), Stable Disease (SD), or Progressive Disease (PD)		Baseline to objective progressive disease (estimated as 6 months)