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COMPLETEDPHASE2

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

Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma

NCT00533702•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (17)

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

Key Dates

Start Date

November 1, 2007

Primary Completion Date

May 1, 2011

Completion Date

May 1, 2011

Last Updated

August 1, 2014

Enrollment

106

ACTUAL participants

Conditions

Metastatic Malignant Melanoma

Interventions

IMC-1121B (ramucirumab)

BIOLOGICAL

Dacarbazine

DRUG

Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma

NCT02617849

Metastatic Malignant Melanoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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