A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma

Completed · Phase 2

Conditions studied: Metastatic Malignant Melanoma

In brief

The primary objective of this study is to determine the progression-free survival (PFS) of participants with previously untreated metastatic malignant melanoma when treated with IMC-1121B (ramucirumab) alone or in combination with dacarbazine.

Key facts

Study ID

NCT00533702

Run by

Eli Lilly and Company

People needed

106

Starts

2007-11-01

Expected to finish

2011-05-01

Last updated by the study team

2014-08-01

Who can join

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

You may qualify if…

• The participant has histologically or cytologically confirmed melanoma that is stage IV (metastatic)
• The participant has an Eastern Cooperative Oncology Performance Status (ECOG PS) of 0-1
• The participant has completed any prior radiotherapy, biologic/immunotherapy or vaccine therapy (for adjuvant or advanced disease) at least six weeks prior to the first dose of study therapy
• The participant has adequate hematological functions [absolute neutrophil count (ANC) ≥ 1500 cells/microliter (μL), hemoglobin ≥ 9 grams/deciliter (g/dL) and platelets ≥ 100,000 cells/μL].
• The participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal (ULN), or ≤ 5.0 times the ULN if the transaminase elevation is due to liver metastases]
• The participant has serum creatinine ≤ 1.5 x ULN [or a calculated creatinine clearance > 60 milliliters/minute (mL/min)]
• The participant's urinary protein ≤ 1+ on dipstick or routine urinalysis [(UA); if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study]
• The participant must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 1.5 X ULN

You may not qualify if…

• The participant has mucosal or intra-ocular melanoma
• The participant has known or suspected brain or leptomeningeal metastases
• The participant has had prior cytotoxic chemotherapy for metastatic malignant melanoma
• The participant has had more than one line of biologic, immunologic or vaccine-based therapy for metastatic malignant melanoma (including therapy for adjuvant or advanced disease)
• The participant has a nonhealing wound or ulcer
• The participant has a known alcohol or drug dependency
• The participant is pregnant or breastfeeding
• The participant has a coexisting medical or psychiatric problem of sufficient severity to limit compliance with the study and/or increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results
• The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator

Where it is running

• ImClone Investigational Site — Decatur, Alabama, United States
• ImClone Investigational Site — Scottsdale, Arizona, United States
• ImClone Investigational Site — Scottsdale, Arizona, United States
• ImClone Investigational Site — Fresno, California, United States
• ImClone Investigational Site — San Francisco, California, United States
• ImClone Investigational Site — Aurora, Colorado, United States
• ImClone Investigational Site — Jacksonville, Florida, United States
• ImClone Investigational Site — Orlando, Florida, United States
• ImClone Investigational Site — Oxford, Mississippi, United States
• ImClone Investigational Site — Missoula, Montana, United States
• ImClone Investigational Site — Buffalo, New York, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — Willow Grove, Pennsylvania, United States
• ImClone Investigational Site — Dallas, Texas, United States
• ImClone Investigational Site — Houston, Texas, United States
• ImClone Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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