NCT02240433CompletedPhase 1
A Phase 1b Study of LY2157299 in Combination With Sorafenib in Patients With Unresectable Hepatocellular Carcinoma
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
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.
Intervention: LY2157299 (Drug)
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.
Intervention: Sorafenib (Drug)
Outcomes
Primary Outcomes
Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)
Time Frame: Cycle 1 (28 days)
Secondary Outcomes
- 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))
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study of LY2157299 in Participants With Pancreatic Cancer That is Advanced or Has Spread to Another Part of the BodyPancreatic NeoplasmsNCT02154646Eli Lilly and Company6
Unknown
Phase 1
A Phase 1b Study of LY2157299 in Combination With Gemcitabine in Patients With Advanced or Metastatic Unresectable Pancreatic Cancer (H9H-JE-JBAO)Pancreatic NeoplasmsJPRN-jRCT2080222513Eli Lilly Japan K.K.
Completed
Phase 1
A Phase 1b Study of LY2157299 in Combination with Sorafenib in Patients with Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaJPRN-jRCT2080222658Eli Lilly Japan K.K.
Terminated
Phase 1
Phase Ib/II Study of LY2780301 in Combination With Weekly PACLITAXEL in HER2-metastatic Breast CancerBreast CancerNCT01980277Institut Paoli-Calmettes68
Completed
Phase 1
A Drug Interaction Study of LY3154207 in Healthy ParticipantsHealthyNCT03942029Eli Lilly and Company36