Status:
COMPLETED
Study of IMC-1121B (Ramucirumab) in Participants With Liver Cancer Who Have Not Previously Been Treated With Chemotherapy
Lead Sponsor:
Eli Lilly and Company
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A study to determine how long ramucirumab (IMC-1121B) will stop cancer from growing in participants with liver cancer that cannot be treated with surgery.
Detailed Description
Inhibition of angiogenesis is considered a promising approach to the treatment of cancer. Members of the vascular endothelial growth factor (VEGF) family and the VEGF receptor-2 (VEGFR-2) are importan...
Eligibility Criteria
Inclusion
- The participant must have histologically-confirmed, unresectable HCC
- The participant has at least one unidimensionally-measurable target lesion \[≥ 2 centimeters (cm) with conventional techniques, or ≥ 1 cm by spiral computed tomography (CT) or magnetic resonance imaging (MRI)\], as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. If a target lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion
- The participant has a Cancer of the Liver Italian Programme (CLIP) score of 0-3
- The participant has a Child-Pugh Classification score of A or B (liver dysfunction)
- The participant has provided signed informed consent
Exclusion
- The participant has received prior systemic chemotherapy, biologic or anti-angiogenic therapy, or investigational systemic therapy for HCC
- The participant has had bleeding from esophageal or gastric varices during the 3 months prior to study participation. Note: If the participant has any history of known esophageal varices, or evidence of esophageal varices on CT/MRI, the participant must undergo endoscopic evaluation prior to study entry (minimally invasive capsule esophageal endoscopy is an acceptable initial modality). The participant with endoscopically detected esophageal varices is eligible provided he/she meets all other entry criteria. The participant with any history or current evidence of esophageal varices must receive oral beta-blocker therapy throughout participation while on study, he/she may receive optimal endoscopic therapy as determined by the consulting gastroenterologist or hepatologist, and must undergo regular endoscopic follow-up throughout participation while on study
- The participant has acute hepatitis
- The participant has central nervous system (CNS) metastases or carcinomatous meningitis
- The participant has poorly-controlled hypertension \[in other words (ie), blood pressure in abnormal range despite medical management\]
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00627042
Start Date
February 1 2008
End Date
May 1 2011
Last Update
October 8 2014
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
ImClone Investigational Site
Los Angeles, California, United States, 90095
2
ImClone Investigational Site
Chicago, Illinois, United States, 60611
3
ImClone Investigational Site
Metairie, Louisiana, United States, 70006
4
ImClone Investigational Site
Boston, Massachusetts, United States, 02114