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Randomized Phase 2 Study of LY2157299 in Patients With Hepatocellular Carcinoma Who Have Had Disease Progression on Sorafenib or Are Not Eligible to Receive Sorafenib


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Hepatocellular

Thank you

Trial Information

Randomized Phase 2 Study of LY2157299 in Patients With Hepatocellular Carcinoma Who Have Had Disease Progression on Sorafenib or Are Not Eligible to Receive Sorafenib


Inclusion Criteria:



- Have histological evidence of a diagnosis of HCC not amenable to curative surgery

- Part A: Serum alpha fetoprotein greater than or equal to 1.5 Upper Limits of Normal,
Part B: Serum alpha fetoprotein less than 1.5 Upper Limits of Normal

- Child-Pugh Stage A or B7

- 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

- Have given written informed consent prior to any study-specific procedures

- Have adequate hematologic, hepatic and renal function

- Have a performance status of equal to or less than 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

- 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
less than or equal to 7 days prior to the first dose of study drug

- Are able to swallow capsules or tablets

Exclusion Criteria:

- 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

- History of liver transplant requiring increased immunosuppressive therapy.
(Participants on maintenance immunosuppressive therapy after liver transplant are
eligible)

- Have received more than 1 line of systemic treatment

- Have moderate or severe cardiac disease:

1. 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

2. Have documented major electrocardiogram (ECG) abnormalities at the
investigator's discretion

3. Have major abnormalities documented by echocardiography with Doppler. For
additional details

4. 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 participants who are stable on GnRH agonist
therapy and breast cancer participants who are stable on antiestrogen therapy may
have that treatment continued

- Have active infection that would interfere with the study objectives or influence
study compliance

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relationship of change in response biomarker to clinical benefit

Outcome Time Frame:

Baseline through discontinuation from any cause

Safety Issue:

No

Principal Investigator

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

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13665

NCT ID:

NCT01246986

Start Date:

March 2011

Completion Date:

May 2015

Related Keywords:

  • Carcinoma
  • Hepatocellular
  • Carcinoma
  • Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

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.Manhassaet, New York  
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.Greenbrae, California  94904
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.Chicago, Illinois  60674
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.Indianapolis, Indiana  46227
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.Dunmore, Pennsylvania  18512
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.Little Rock, Arkansas  72205
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.Washington, District of Columbia  20007