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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00627042
First received: February 18, 2008
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

A study to determine how long ramucirumab will stop cancer from growing in patients with liver cancer that cannot be treated with surgery.


Condition Intervention Phase
Hepatocellular Carcinoma
Biological: Ramucirumab (IMC-1121B)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression free survival (PFS) in patients with unresectable hepatocellular cancer treated with the monoclonal antibody ramucirumab. [ Time Frame: Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response. ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response. ] [ Designated as safety issue: Yes ]
  • Objective response rate [ Time Frame: Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response. ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response. ] [ Designated as safety issue: Yes ]
  • Serum Anti-Ramucirumab Antibody Assessment [ Time Frame: Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response. ] [ Designated as safety issue: Yes ]
  • Summary Listing of Participants Reporting Treatment-Emergent Adverse Events [ Time Frame: Every 6 weeks, with confirmatory assessment at least 4 weeks subsequent to initial objective response. ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: February 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab (IMC-1121B) Biological: Ramucirumab (IMC-1121B)
Patients will receive ramucirumab (IMC-1121B) at 8 mg/kg administered over 1 hour every other week (every 14 days). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met.
Other Names:
  • IMC-1121B
  • LY3009806

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627042

Locations
United States, California
ImClone Investigational Site
Los Angeles, California, United States, 90095
United States, Illinois
ImClone Investigational Site
Chicago, Illinois, United States, 60611
United States, Louisiana
ImClone Investigational Site
Metairie, Louisiana, United States, 70006
United States, Massachusetts
ImClone Investigational Site
Boston, Massachusetts, United States, 02114
ImClone Investigational Site
Burlington, Massachusetts, United States, 01805
United States, Pennsylvania
ImClone Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00627042     History of Changes
Other Study ID Numbers: 13922, CP12-0710, I4T-IE-JVBQ
Study First Received: February 18, 2008
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Liver disease
Neoplasms
Liver neoplasms
Carcinoma, Hepatocellular

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on April 16, 2014