Study of IMC-1121B (Ramucirumab) in Patients With Liver Cancer Who Have Not Previously Been Treated With Chemotherapy
This study has been completed.
Sponsor:
ImClone LLC
Information provided by (Responsible Party):
ImClone LLC
ClinicalTrials.gov Identifier:
NCT00627042
First received: February 18, 2008
Last updated: August 23, 2012
Last verified: August 2012
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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 ImClone LLC:
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:
|
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:
- The patient must have histologically-confirmed, unresectable HCC
- 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
- The patient has a Cancer of the Liver Italian Programme (CLIP) score of 0-3 (see Section 3.2.1)
- The patient has a Child-Pugh Classification score of A or B (liver dysfunction, see Section 3.2.1)
- The patient has provided signed informed consent
Exclusion Criteria:
- The patient has received prior systemic chemotherapy, biologic or anti-angiogenic therapy, or investigational systemic therapy for HCC
- 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
- The patient has acute hepatitis
- The patient has central nervous system (CNS) metastases or carcinomatous meningitis
- 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
ImClone LLC
Investigators
| Study Director: | E-mail: ClinicalTrials@ ImClone.com | ImClone LLC |
More Information
No publications provided
| Responsible Party: | ImClone LLC |
| 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 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ImClone LLC:
|
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 May 19, 2013