Melanoma Clinical Trial

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

Summary

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.

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Full Description

The purpose of this study is to determine the antitumor activity and safety profile of IMC-1121B (ramucirumab) when used alone or in combination with dacarbazine in participants with metastatic melanoma who have not received prior chemotherapy for this disease.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

106

Study ID:

NCT00533702

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 17 Locations for this study

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ImClone Investigational Site
Decatur Alabama, 35601, United States
ImClone Investigational Site
Scottsdale Arizona, 85258, United States
ImClone Investigational Site
Scottsdale Arizona, 85260, United States
ImClone Investigational Site
Fresno California, 93720, United States
ImClone Investigational Site
San Francisco California, 94109, United States
ImClone Investigational Site
Aurora Colorado, 80045, United States
ImClone Investigational Site
Jacksonville Florida, 32256, United States
ImClone Investigational Site
Orlando Florida, 32806, United States
ImClone Investigational Site
Oxford Mississippi, 38655, United States
ImClone Investigational Site
Missoula Montana, 59806, United States
ImClone Investigational Site
Buffalo New York, 14263, United States
ImClone Investigational Site
New York City New York, 10016, United States
ImClone Investigational Site
New York New York, 10021, United States
ImClone Investigational Site
Willow Grove Pennsylvania, 19090, United States
ImClone Investigational Site
Dallas Texas, 75230, United States
ImClone Investigational Site
Houston Texas, 77030, United States
ImClone Investigational Site
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

106

Study ID:

NCT00533702

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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