A Rollover Study for Patients Who Received CP-675,206 in Other Protocols, to Allow the Patients Access to CP-675,206 Until This Agent Becomes Commercially Available or Development is Discontinued.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00378482
Recruitment Status : Active, not recruiting
First Posted : September 20, 2006
Last Update Posted : December 6, 2017
Information provided by (Responsible Party):

Brief Summary:
This study is intended to provide access to CP-675,206 for patients who have previously received CP-675,206 in a clinical trial.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Melanoma Prostatic Neoplasms Renal Cell Carcinoma Neoplasms Patients Who Have/Have Had Melanoma and Other Tumors Drug: CP-675,206 (Tremelimumab) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Rollover Protocol For Patients Who Received CP-675,206 In Other Protocols
Actual Study Start Date : March 1, 2008
Estimated Primary Completion Date : January 11, 2019
Estimated Study Completion Date : January 11, 2019

Arm Intervention/treatment
Experimental: 1
Drug: CP-675,206 (Tremelimumab)
Drug: CP-675,206 (Tremelimumab)
15 mg/kg IV every 3 months as long as required
Other Name: anti-CTLA4 human monoclonal antibody

Primary Outcome Measures :
  1. Safety Endpoints: • Serious adverse events • Grade 3 or 4 CP-675,206-related adverse events • Immune-mediated adverse events • Hypersensitivity reactions to CP-675,206 [ Time Frame: as long as required ]
  2. Efficacy Endpoints: • Tumor status: alive with disease (AWD) or no evidence of disease (NED) • Survival [ Time Frame: as long as required ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject must have already received CP-675,206 in another protocol
  • Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
  • Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00378482

United States, Alabama
Research Site
Birmingham, Alabama, United States, 35223
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72205
United States, California
Research Site
Los Angeles, California, United States, 90095
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, Florida
Research Site
Tampa, Florida, United States, 33612
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46202
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48109
United States, New York
Research Site
New York, New York, United States, 10016
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53792
Research Site
Meldola, FC, Italy, 47014
United Kingdom
Research Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Responsible Party: AstraZeneca Identifier: NCT00378482     History of Changes
Other Study ID Numbers: D4881C00024
A3671024 ( Other Identifier: Pfizer study code )
First Posted: September 20, 2006    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017

Keywords provided by AstraZeneca:
Melanoma and other tumors

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Colorectal Neoplasms
Prostatic Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genital Neoplasms, Male
Genital Diseases, Male