Know Cancer

forgot password

An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B as First Line Monotherapy in Patients With Unresectable Hepatocellular Cancer.

Phase 2
18 Years
Not Enrolling
Hepatocellular Carcinoma

Thank you

Trial Information

An Open Label, Multicenter, Phase 2 Study Evaluating the Safety and Efficacy of IMC-1121B as First Line Monotherapy in Patients With Unresectable Hepatocellular Cancer.

Inhibition of angiogenesis is considered a promising approach to the treatment of cancer.
Members of the VEGF family and the VEGFR-2 are important mediators of angiogenesis and are
likely important therapeutic targets in advanced HCC.

Angiogenesis appears integral to HCC development and pathogenesis. Angiogenesis inhibition
has been efficacious in both in vitro and in vivo HCC models and results of clinical studies
also suggest potential to inhibit disease growth.

Ramucirumab is a fully human MAb that specifically binds to the extracellular domain of
VEGFR-2 with high affinity. Phase 1 studies currently nearing completion have demonstrated
safety and tolerability at clinically relevant doses, with preliminary evidence of clinical
efficacy in a variety of human cancers.

Inclusion Criteria:

1. The patient must have histologically-confirmed, unresectable HCC

2. The patient has at least one unidimensionally-measurable target lesion (≥ 2 cm with
conventional techniques, or ≥ 1 cm by spiral CT or MRI), as defined by Response
Evaluation Criteria in Solid Tumors (RECIST).[61] 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

3. The patient has a Cancer of the Liver Italian Programme (CLIP) score of 0-3 (see
Section 3.2.1)

4. The patient has a Child-Pugh Classification score of A or B (liver dysfunction, see
Section 3.2.1)

5. The patient has provided signed informed consent

Exclusion Criteria:

1. The patient has received prior systemic chemotherapy, biologic or anti-angiogenic
therapy, or investigational systemic therapy for HCC

2. The patient has had bleeding from esophageal or gastric varices during the 3 months
prior to study participation. Note: If the patient has any history of known
esophageal varices, or evidence of esophageal varices on CT/MRI, the patient must
undergo endoscopic evaluation prior to study entry (minimally invasive capsule
esophageal endoscopy is an acceptable initial modality). The patient with
endoscopically detected esophageal varices is eligible provided he/she meets all
other entry criteria. The patient 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

3. The patient has acute hepatitis

4. The patient has central nervous system (CNS) metastases or carcinomatous meningitis

5. The patient has poorly-controlled hypertension (ie, blood pressure in abnormal range
despite medical management)

Type of Study:


Study Design:

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

Outcome Measure:

Progression free survival (PFS) in patients with unresectable hepatocellular cancer treated with the monoclonal antibody ramucirumab.

Outcome Time Frame:

Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response.

Safety Issue:


Principal Investigator

E-mail: ClinicalTrials@

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

May 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver disease
  • Neoplasms
  • Liver neoplasms
  • Carcinoma, Hepatocellular
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site New Orleans, Louisiana  70121
ImClone Investigational Site Philadelphia, Pennsylvania  19107
ImClone Investigational Site Boston, Massachusetts  02135