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

NCT00627042 | Completed Phase 2 Results

• 3 other identifiers: 13922CP12-0710I4T-IE-JVBQ
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 6

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.

Conditions

Hepatocellular Carcinoma

Keywords

Liver disease; Neoplasms; Liver neoplasms; Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer Treated With the Monoclonal Antibody Ramucirumab

  PFS was defined as the time from the first day of therapy to the first evidence of disease progression or death from any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, disease progression was having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Participants who were alive and without disease progression and participants who did not progress and were subsequently lost to follow-up were censored at the last objective tumor assessment.

  First dose to date of progressive disease or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]

Secondary Outcomes (6)

• Time to Progression

  First dose to date of PD [every 3 cycles up to 18 months (1 cycle=2 weeks)]

• Overall Survival

  First dose to death due to any cause up to 37.5 months

• Percentage of Participants With Complete Response or Partial Response (Objective Response Rate)

  First dose to date of objective progressive disease (PD) or death up to 18 months

• Duration of Response

  Time of first response (CR or PR) to disease progression, or death due to any cause [every 3 cycles up to 18 months (1 cycle=2 weeks)]

• Number of Participants With Serum Anti-Ramucirumab Antibodies

  Prior to dosing at baseline, Cycles 4 and 7, and 30 days after end of therapy (1 cycle=2 weeks)

Study Arms (1)

Ramucirumab (IMC-1121B)

EXPERIMENTAL

Biological: Ramucirumab (IMC-1121B)

Interventions

Ramucirumab (IMC-1121B) BIOLOGICAL

Participants will receive ramucirumab (IMC-1121B) at 8 milligrams per kilogram (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.

Also known as: Ramucirumab, IMC-1121B, LY3009806

Ramucirumab (IMC-1121B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[in other words (ie), blood pressure in abnormal range despite medical management\]

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

ImClone Investigational Site

Los Angeles, California, 90095, United States

Location

ImClone Investigational Site

Chicago, Illinois, 60611, United States

Location

ImClone Investigational Site

Metairie, Louisiana, 70006, United States

Location

ImClone Investigational Site

Boston, Massachusetts, 02114, United States

Location

ImClone Investigational Site

Burlington, Massachusetts, 01805, United States

Location

ImClone Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Diseases; Neoplasms; Liver Neoplasms

Interventions

Ramucirumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The duration of response results should be interpreted with caution since the sample size for this analysis was very small (2 participants).

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 8, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-09

Locations

US (6)