Randomized Phase 2 Study of LY2157299 in Patients with Hepatocellular Carcinoma who Have Had DiseaseProgression on Sorafenib or Are Not Eligible to Receive Sorafenib - ND
- Conditions
- Hepatocellular CarcinomaMedDRA version: 13.1Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-022338-10-IT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 204
Have histological evidence of a diagnosis of HCC not amenable to curative surgery
[2] Child-Pugh Stage A
[3] Serum AFP =1.5 upper limit of normal (ULN)
[4] Have the presence of measurable disease as defined by the RECIST 1.1 (Eisenhauer et al. 2009; . A lesion that has been previously treated by local therapy will
qualify as a measurable or evaluable lesion if there was demonstrable progression following
locoregional therapy.
[5] Age >18 years
[6] Have given written informed consent prior to any study-specific procedures
[7] Have adequate organ function including:
- Hematologic: absolute neutrophil count (ANC) >1.5 x 109/L, platelets >75 x 109/L, and hemoglobin >8 g/dL
- Hepatic: bilirubin =2.5 times ULN); alanine aminotransaminase (ALT) and aspartate aminotransaminase (AST) <5ULN. Prothrombin time international normalized ratio, <2.3; or
prothrombin time, <6 seconds above control).
- Renal: Serum creatinine <1.5 times ULN or calculated creatinine clearance >45 mL/min
[8] Have a performance status of =1 on the Eastern Cooperative Oncology Group (ECOG) scale
[9] Have either:
- received sorafenib and have progressed or were intolerant to sorafenib, or
- are ineligible for sorafenib treatment (at the investigator’s discretion)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an
investigational drug or device or not approved use of a drug or device, or concurrently enrolled in any
other type of medical research judged not to be scientifically or medically compatible with this study
[16] Known HCC with fibro-lamellar or mixed histology
[17] Presence of clinically relevant ascites
[18] History of liver transplant
[19] Have received >1 line of systemic treatment
[20] Have moderate or severe cardiac disease: (see Section 8.2)
[21] Have serious preexisting medical conditions that, in the opinion of the investigator, cannot be
adequately controlled with appropriate therapy or would preclude participation in this study
[22] Females who are pregnant or lactating.
[23] Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the
cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years
[24] Have active infection that would interfere with the study objectives or influence study compliance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method