Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Bristol-Myers Squibb Medarex |
---|---|
Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00796991 |
The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine
Condition | Intervention | Phase |
---|---|---|
Advanced Melanoma |
Drug: Ipilimumab Drug: Carboplatin Drug: Paclitaxel Drug: Dacarbazine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Parallel, 3-Arm Study to Characterize the Effect of Ipilimumab + Chemotherapy in Patients With Untreated Advanced Melanoma |
Estimated Enrollment: | 60 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm A: Active Comparator |
Drug: Ipilimumab
Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks
Drug: Carboplatin
Solution, intravenous, AUC=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
Drug: Paclitaxel
Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
|
Arm B: Active Comparator |
Drug: Ipilimumab
Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks
Drug: Dacarbazine
Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
|
Arm C: Active Comparator |
Drug: Ipilimumab
Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
United States, California | |
Local Institution | |
Los Angeles, California, United States, 90025 | |
United States, Florida | |
Local Institution | |
Tampa, Florida, United States, 33612 | |
United States, New York | |
Local Institution | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Local Institution | |
Charlotte, North Carolina, United States, 28204 | |
United States, Oregon | |
Local Institution | |
Bethlehem, Oregon, United States, 18015 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA184-078 |
Study First Received: | November 20, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00796991 |
Health Authority: | United States: Food and Drug Administration |
Untreated Advanced Melanoma |
Neuroectodermal Tumors Dacarbazine Paclitaxel Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Carboplatin Nevus Neuroendocrine Tumors Melanoma |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Mitosis Modulators Antimitotic Agents Pharmacologic Actions |
Neoplasms Therapeutic Uses Tubulin Modulators Nevi and Melanomas Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic Alkylating Agents |