Clinical trial · Interventional
Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody
An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations
NCT00431275CI-TRIAL-00007086completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CP-675,206 | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Commercial Formulation
- description
- Commercial Formulation
- interventionNames
- Drug: CP-675,206
- type
- EXPERIMENTAL
- label
- Current Formulation
- description
- Current Formulation
- interventionNames
- Drug: CP-675,206
Primary outcomes (2)
- measure
- Pharmacokinetics: maximum plasma concentration of CP-675,206
- timeFrame
- 1 hour
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.