Phase 2
N=132
A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02178358 ↗Enrolled (actual)
132
Serious AEs
36.4%
Results posted
Dec 2020
Primary outcome: Primary: Overall Survival (OS): Number of Events — 15; 58; 31 Participants with events — p=0.837
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2157299 (Drug); Sorafenib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS): Number of Events |
15; 58; 31 | 0.837 |
| SECONDARY Population Pharmacokinetics (PopPK): Mean Population Clearance of Galunisertib |
33.6 | — |
| SECONDARY Population Pharmacokinetics (PopPK): Steady State Apparent Volume of Distribution (Vss) of Galunisertib |
192 | — |
| SECONDARY Time to Tumor Progression (TTP) |
1.41; 2.86; 4.14 | — |
| SECONDARY Progression-Free Survival (PFS) |
1.41; 2.86; 4.14 | — |
| SECONDARY Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) |
0.05; 0.027; 0.158 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score |
43.42; 55.90; 58.57; 84.56; 82.87; 80.95 | — |
| SECONDARY Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score |
24.56; 32.82; 27.62; 28.07; 58.97; 46.08 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02178358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.