A Study of Ramucirumab With or Without Dacarbazine in Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00533702
First received: September 17, 2007
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Metastatic Malignant Melanoma
Biological: IMC-1121 (ramucirumab )
Drug: Dacarbazine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Randomized, Open-Label Study of IMC-1121B With or Without Dacarbazine in Patients With Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression Free survival (PFS) [ Time Frame: Approximately 18 weeks ] [ Designated as safety issue: Yes ]
    PFS is defined as the time from randomization to the first evidence of progression as defined by RECIST or death from any cause.


Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Approximately 18 weeks ] [ Designated as safety issue: Yes ]
  • Overall response rate (ORR) [ Time Frame: Approximately 18 weeks ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Approximately 18 weeks ] [ Designated as safety issue: No ]
  • Proportion of Participants Stable disease (SD) at 6-weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Proportion of Participants Stable disease (SD) at 12-weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Response rate at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) [ Time Frame: Day 1 (cycle 1,2, 3, 4, 5, and 6) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) [ Time Frame: Day 7 (cycle 1) ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) [ Time Frame: Day 14 (cycle 1) ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: November 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMC-1121B
IMC-1121B
Biological: IMC-1121 (ramucirumab )
10 mg/kg i.v. every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Other Name: ramucirumab
Active Comparator: IMC-1121B + dacarbazine
IMC-1121 + dacarbazine
Biological: IMC-1121 (ramucirumab )
10 mg/kg i.v. every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Other Name: ramucirumab
Drug: Dacarbazine
1000 mg/m2 i.v. every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
Other Names:
  • DIC
  • Imidazole
  • Carboxamide

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has histologically or cytologically confirmed melanoma that is stage IV (metastatic)
  • The patient has an ECOG PS of 0-1
  • The patient 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 patient has adequate hematological functions (absolute neutrophil count [ANC]≥ 1500 cells/μL, hemoglobin ≥ 9 g/dL and platelets ≥ 100,000 cells/μL).
  • The patient 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 patient has serum creatinine ≤ 1.5 x ULN (or a calculated creatinine clearance > 60 mL/min)
  • The patient'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 mg of protein in 24 hours to allow participation in the study)
  • The patient 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 patient has mucosal or intra-ocular melanoma
  • The patient has known or suspected brain or leptomeningeal metastases
  • The patient has had prior cytotoxic chemotherapy for metastatic malignant melanoma
  • The patient 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 patient has a nonhealing wound or ulcer
  • The patient has a known alcohol or drug dependency
  • The patient is pregnant or breastfeeding
  • The patient 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 patient 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533702

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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00533702     History of Changes
Other Study ID Numbers: 13920, CP12-0604, I4T-IE-JVBO
Study First Received: September 17, 2007
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Phase II
Melanoma
IMC-1121B
ImClone

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014