Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments ly2157299, sorafenib
Phase phase 1
Targets PDGF, RAF, TGFBR1, VEGF, FLT-3, KIT
Sponsor Eli Lilly and Company
Start date November 2014
End date December 2016
Trial size 9 participants
Trial identifier NCT02240433, 14856, H9H-JE-JBAP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
LY2157299 will be administered orally twice daily for 14 days, followed by 14 days with no study drug per 28-day cycle. Sorafenib will be administered orally twice daily for 28 days, in each cycle.
ly2157299
LY2157299 administered orally
sorafenib
Sorafenib administered orally

Primary Outcomes

Measure
Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)
time frame: Cycle 1 (28 days)

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title A Phase 1b Study of LY2157299 in Combination With Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.