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

Lilly

Status and phase: Completed; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: LY2157299; Drug: Sorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02240433

14856

H9H-JE-JBAP (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

LY2157299 + Sorafenib

Experimental group

Description:

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.

Treatment:

Drug: LY2157299

Drug: Sorafenib