A Study of LY2157299 in Patients With Liver Cancer
- Conditions
- Carcinoma, hepatocellularMedDRA version: 20.0Level: LLTClassification code 10019829Term: Hepatocellular carcinoma recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022338-10-DE
- 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
- Have serum alpha fetoprotein:
• =1.5 Upper Limit of Normal (Part A)
• <1.5 Upper Limit of Normal (Part B)
- Child-Pugh Class:
• Parts A and B: A or B7
• Part C: A
- Have the presence of measurable disease as defined by the Response
Evaluation Criteria in Solid Tumors (RECIST 1.1). 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
- Age =18 years
- Have given written informed consent prior to any study-specific
procedures
- Have adequate hematologic, hepatic and renal function
- Have a performance status of =1 on the Eastern Cooperative Oncology
Group (ECOG) scale
- Have received sorafenib and have progressed or were intolerant to
sorafenib or are ineligible for sorafenib treatment (Parts A and B)
- Have not received previous systemic treatment (Part C)
- Are reliable and willing to make themselves available for the duration
of the study and are willing to follow study procedures
- Males and females with reproductive potential must agree to use
medically approved contraceptive precautions during the trial and for 3
months following the last dose of study drug
- Females with childbearing potential must have had a negative serum
pregnancy test =7 days prior to the first dose of study drug
- Are able to swallow capsules or tablets
- Child-Pugh Class:
• Parts A and B: A or B7
• Part C: A
- Have the presence of measurable disease as defined by the Response
Evaluation Criteria in Solid Tumors (RECIST 1.1). 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
- Age =18 years
- Have given written informed consent prior to any study-specific
procedures
- Have adequate hematologic, hepatic and renal function
- Have a performance status of =1 on the Eastern Cooperative Oncology
Group (ECOG) scale
- Have received sorafenib and have progressed or were intolerant to
sorafenib or are ineligible for sorafenib treatment (Parts A and B)
- Have not received previous systemic treatment (Part C)
- Are reliable and willing to make themselves available for the duration
of the study and are willing to follow study procedures
- Males and females with reproductive potential must agree to use
medically approved contraceptive precautions during the trial and for 3
months following the last dose of study drug
- Females with childbearing potential must have had a negative serum
pregnancy test =7 days prior to the first dose of study drug
- Are able to swallow capsules or tablets
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 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
- 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 (other than the study drug 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
- Known HCC with fibro-lamellar or mixed histology
- Presence of clinically relevant ascitis
- Liver transplant requiring increased immunosuppressive therapy.
(Patients on maintenance immunosuppressive therapy after liver
transplant are eligible for Parts A and B. Rapamycin analogues are not
allowed.)
- Have received > 1 line of systemic treatment (Parts A and B)
- Have moderate or severe cardiac disease:
a. Have the presence of cardiac disease, including a myocardial
infarction within 6 months prior to study entry, unstable angina pectoris,
New York Heart Association (NYHA) Class III/IV congestive heart
failure, or uncontrolled hypertension
b. Have documented major ECG abnormalities at the investigator's
discretion
c. Have major abnormalities documented by echocardiography with
Doppler.
d. Have predisposing conditions that are consistent with development of
aneurysms of the ascending aorta or aortic stress
- Have serious preexisting medical conditions that, in the opinion of the
investigator, that cannot be adequately controlled with appropriate
therapy or would preclude participation in this study
- Females who are pregnant or lactating
- Have a history of any other cancer (except non-melanoma 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. At the discretion of
the investigator, hormone-refractory prostate cancer patients who are
stable on GnRH agonist therapy and breast cancer patients who are
stable on antiestrogen therapy (for example, an aromatase inhibitor)
may have that treatment continued while they are enrolled in this study.
- Have active infection that would interfere with the study objectives or
influence study compliance
- For Part C, have a known hypersensitivity to sorafenib or its excipients
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