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

NCT02240433 | Completed Phase 1 DMC

• 2 other identifiers: 14856H9H-JE-JBAP
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  Cycle 1 (28 days)

Secondary Outcomes (5)

• Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve (AUC) of LY2157299

  Cycle 1 Day1: predose through 6 hours post dose; Cycle1 Day14: predose through 24 hours post dose

• PK: Maximum Observed Plasma Concentration (Cmax) of LY2157299

  Cycle 1 Day 1: Predose through 6 hours post dose; Cycle 1 Day 14: Predose through 24 hours post dose

• Time to Progression (TTP)

  Baseline to objective progressive disease (estimated as 6 months)

• Progression-free Survival (PFS)

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

• The Number of Participants with Best Response of Partial Response (PR), Complete Response (CR), Stable Disease (SD), or Progressive Disease (PD)

  Baseline to objective progressive disease (estimated as 6 months)

Study Arms (1)

LY2157299 + Sorafenib

EXPERIMENTAL

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.

Drug: LY2157299; Drug: Sorafenib

Interventions

LY2157299 DRUG

LY2157299 administered orally

LY2157299 + Sorafenib

Sorafenib DRUG

Sorafenib administered orally

LY2157299 + Sorafenib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

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, 277 8577, Japan

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.

Kanagawa, 241-8515, Japan

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.

Suita-shi, 565-0871, Japan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

LY-2157299; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: November 12, 2014
• Primary Completion: July 19, 2017
• Study Completion: December 25, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02-01

Locations

JP (3)