Study of IMC-1121B (Ramucirumab) in Participants With Liver Cancer Who Have Not Previously Been Treated With Chemotherapy

Completed · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT00627042

Run by

Eli Lilly and Company

People needed

42

Starts

2008-02-01

Expected to finish

2011-05-01

Last updated by the study team

2014-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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]

Where it is running

• ImClone Investigational Site — Los Angeles, California, United States
• ImClone Investigational Site — Chicago, Illinois, United States
• ImClone Investigational Site — Metairie, Louisiana, United States
• ImClone Investigational Site — Boston, Massachusetts, United States
• ImClone Investigational Site — Burlington, Massachusetts, United States
• ImClone Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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