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.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00378482
First received: September 19, 2006
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Rollover Protocol For Patients Who Received CP-675,206 In Other Protocols

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Efficacy Endpoints: • Tumor status: alive with disease (AWD) or no evidence of disease (NED) • Survival [ Time Frame: as long as required ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: March 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378482

Locations
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
Italy
Research Site
Meldola, FC, Italy, 47014
United Kingdom
Research Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Ramy Ibrahim, Senior Director MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00378482     History of Changes
Other Study ID Numbers: D4881C00024, A3671024
Study First Received: September 19, 2006
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
Melanoma and other tumors

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Renal Cell
Colorectal Neoplasms
Melanoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
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
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Genital Neoplasms, Male
Genital Diseases, Male

ClinicalTrials.gov processed this record on August 26, 2014