Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.

November 6, 2019 updated by: Celgene

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma Whose Disease Has Progressed on Treatment With DTIC, IL-2, or IFN Based Therapy

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Camperdown, New South Wales, Australia, 2145
        • Sydney cancer centre
      • Newcastle, New South Wales, Australia, 2300
        • Royal Newcastle Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Roayl Brisbane Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7001
        • Royal Hobart Hospital
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6009
        • Mount HospitalOncology
  • Estonia
      • Tallinn, Estonia, 11619
        • North-Estonian Regional Hospital
      • Tartu, Estonia, 51003
        • Tartu University Clinics Onkology & Haematology Clinic
  • Germany
      • Berlin, Germany, D-10117
        • Klinick fur Dermatologie
      • Bochum, Germany, 44791
        • Dermatologie Klinik der Ruhr Universitat Bochum- St. Joseph's Hospital
      • Bonn, Germany, 53105
        • Klinick fur Dermatolgie
      • Freiburg, Germany, 79104
        • Universitatsklinikum Freiburg
      • Hamburg, Germany, D-20246
        • Universitätsklinik Eppendorf
      • Kiel, Germany, D-24105
        • Kinkum der Christian-Albrecht-Universitat KielDepartment of Dermatologie
      • Mannheim, Germany, D-68135
        • Klinik fur DermatologieVenerologie und Allergologie
  • Latvia
      • Riga, Latvia, LV-1079
        • Latvian Onkology Centre
  • Lithuania
      • Klaipeda, Lithuania, LT-5808
        • Klaipeda Hospital
      • Vilnius, Lithuania, LT-2600
        • Vilnius University Onkology Institute
  • Netherlands
      • Rotterdam, Netherlands
        • Daniel DenHoed Kliniek
  • South Africa
      • Cape Town, South Africa, 7506
        • Panorama Medi-Clinic / Panorama Oncology Unit
      • Durban, South Africa, 4001
        • Addington Hospital
      • Hatfield, Pretoria, South Africa, 0028
        • Wilgers Hospital / Wilgers Oncology Centre
      • Morningside, Johannesburg, South Africa
        • Sandton Oncology Centre
      • Port Elizabeth, South Africa, 6001
        • St. Georges Hospital
      • Pretoria, South Africa, 0002
        • Little Company of Mary / Mary Potter Oncology Centre
      • Pretoria, South Africa
        • Pretoria Academic Hospital / Department Medical Oncology
      • Westridge, Durban, South Africa, 4001
        • Durban Oncology Centre
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Dnipropetrovsk State Medical Academy
      • Kharkov, Ukraine, 61070
        • Kharkov Postgraduate Medical Academy, Kharkov Regional Clinical Oncology Center
      • Kiev, Ukraine, 03022
        • Scientific Research Institute of OncologySoft Tissue Department
      • Kiev, Ukraine, 3115
        • Kiev City Oncology Hospital
      • Lviv, Ukraine, 79010
        • Lviv State Medical University Regional Oncology Centre
      • Odessa, Ukraine, 65055
        • Odessa Regional Oncology DispensaryChemotherapy Dept
      • Uzhgorod, Ukraine, 88000
        • Uzhgorod Regional Oncology Diepensary
  • United Kingdom
      • Glasgow, United Kingdom, G11 6NT
        • Beatson Oncology CentreWestern InfirmaryOncology
      • Leeds, United Kingdom, LS9 7TF
        • Cancer Research BldgDivsion of Cancer Medicine Research
      • London, United Kingdom, SW17 0QT
        • St. George's Hospital
      • London, United Kingdom
        • Royal Marsden Hospital
      • London, United Kingdom, NW3 2QG
        • Roayl Free Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital Department of Oncology
      • Newcastle, United Kingdom, NE4 6BE
        • Newcastle GeneralOncology
    • Birmingham
      • Egbaston, Birmingham, United Kingdom, B15 2TH
        • Cancer Centre
    • Manchester
      • Withington, Manchester, United Kingdom, M2O 4BX
        • Christies Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Understand and voluntarily sign an informed consent form
  • Able to adhere to the study visit schedule and other protocol requirements
  • Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
  • Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ICON Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2002

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2003

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-5013-MEL-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings