Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00431275
First received: February 2, 2007
Last updated: June 5, 2012
Last verified: June 2012
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Purpose
This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: CP-675,206 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Pharmacokinetics: maximum plasma concentration of CP-675,206 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Pharmacokinetics: AUC, defined as the area under the concentration -time curve [ Time Frame: Time 0 to Day 85 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Human-anti-human antibodies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Safety laboratory tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Proportion of patients alive and free of disease at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 85 |
| Study Start Date: | June 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Commercial Formulation
Commercial Formulation
|
Drug: CP-675,206
CP-675,206 15 mg/kg iv single dose on Day 1
Other Name: anti-CTLA4 human monoclonal antibody
|
|
Experimental: Current Formulation
Current Formulation
|
Drug: CP-675,206
CP-675,206 15 mg/kg iv single dose on Day 1
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Stage III or Stage IV melanoma
- No evidence of disease following resection of melanoma lesions
- Recovered from all prior surgical or adjuvant treatment-related toxicities
Exclusion Criteria:
- History of chronic inflammatory or autoimmune disease
- History of inflammatory bowel disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431275
Locations
| United States, Arizona | |
| Research Site | |
| Scottsdale, Arizona, United States, 85260 | |
| United States, Colorado | |
| Research Site | |
| Aurora, Colorado, United States, 80010 | |
| United States, Florida | |
| Research Site | |
| Aventura, Florida, United States, 33180 | |
| Research Site | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Georgia | |
| Research Site | |
| Atlanta, Georgia, United States, 30322 | |
| United States, New York | |
| Research Site | |
| New York, New York, United States, 10016 | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Research Site | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
Sponsors and Collaborators
AstraZeneca
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00431275 History of Changes |
| Other Study ID Numbers: | A3671011 |
| Study First Received: | February 2, 2007 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013