Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments ly2157299, sorafenib, placebo
Phase phase 2
Targets RAF, TGFBR1, FLT-3, KIT, PDGF, VEGF
Sponsor Eli Lilly and Company
Start date August 2014
End date October 2017
Trial size 120 participants
Trial identifier NCT02178358, 15065, H9H-MC-JBAS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
150 milligrams (mg) LY2157299 administered orally, twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles).
ly2157299
Administered orally
(Experimental)
80 or 150 mg LY2157299 administered orally, BID for 14 days followed by 14 days with no study drug (28 day cycles). 400 mg sorafenib administered orally BID for 28 days.
ly2157299
Administered orally
sorafenib
Administered orally
(Placebo Comparator)
Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 day cycles). 400 mg sorafenib administered orally BID for 28 days.
sorafenib
Administered orally
placebo
Administered orally

Primary Outcomes

Measure
Overall Survival (OS)
time frame: Baseline to Date of Death from Any Cause (Estimated up to 33 Months)

Secondary Outcomes

Measure
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY2157299 and LY2157299 in Combination with Sorafenib
time frame: Cycle 1: Day 14 Predose up to 24 Hours Postdose on Day 15
Time to Tumor Progression
time frame: Baseline to Date of Objective Progression (Estimated up to 33 Months)
Progression Free Survival
time frame: Baseline to Objective Progression or Death from Any Cause (Estimated up to 33 Months)
Objective Response Rate
time frame: Baseline to Objective Progression or Death from Any Cause (Estimated up to 33 Months)
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score
time frame: Baseline to Objective Disease Progression or Participants Stop Study (Estimated up to 33 Months)
Change from Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score
time frame: Baseline to Objective Disease Progression or Participants Stop Study (Estimated up to 33 Months)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Randomized Phase 2 Study of LY2157299 Versus LY2157299 - Sorafenib Combination Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.