A Study of LY2157299 in Participants With Advanced Hepatocellular Carcinoma

Lilly

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Sorafenib; Drug: Placebo; Drug: LY2157299

Study type: Interventional

Funder types: Industry

Identifiers

NCT02178358

15065

H9H-MC-JBAS (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

132 participants in 3 patient groups, including a placebo group

150 milligram (mg) Galunisertib Monotherapy

Experimental group

Description:

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

Treatment:

Drug: LY2157299

150 mg Galunisertib + 400 mg Sorafenib Therapy

Experimental group

Description:

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.

Treatment:

Drug: Sorafenib

Drug: LY2157299

400 mg Sorafenib + Placebo Therapy

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sorafenib

Drug: Placebo