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:
MedImmune LLC
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00378482
First received: September 19, 2006
Last updated: September 14, 2012
Last verified: September 2012
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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
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 14, 2012 |
| 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 May 19, 2013