Skip to main content
OpenTrials
Completed

NCT Number: NCT02240433

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY2157299

Drug

LY2157299 administered orally

Sorafenib

Drug

Sorafenib administered orally

Primary outcomes

  1. Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)

    Time frame: Cycle 1 (28 days)

Secondary outcomes

  1. 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

  2. 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

  3. Time to Progression (TTP)

    Time frame: Baseline to objective progressive disease (estimated as 6 months)

  4. Progression-free Survival (PFS)

    Time frame: Baseline to objective progressive disease or death (estimated as 6 months)

  5. 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)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1b Study of LY2157299 in Combination With Sorafenib in Patients With Unresectable Hepatocellular Carcinoma

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Sep 15, 2014
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.