DDI - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb Medarex
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00796991

Purpose

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

MedlinePlus related topics: Melanoma

Drug Information available for: Carboplatin Dacarbazine Paclitaxel Ipilimumab

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Pharmacokinetic parameters [Cmax, Tmax, AUC, T-HALF, and Clearence] will be derived from plasma concentration versus time for Ipilimumab, Paclitaxel and Dacarbazine [ Time Frame: Within the 7 weeks (after 3rd dose) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: Safety will be evaluated for all treated subjects using NCI Common Terminology Criteria for Adverse events v3.0 criteria [ Time Frame: Up to Week 48 ] [ Designated as safety issue: Yes ]
Efficacy: Tumor response evaluations will be based on both mWHO criteria and immune-related Response criteria [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
Pharmacodynamic: Pre- and post-treatment immune response will be assessed using absolute lymphocyte count [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologic diagnosis of advanced malignant melanoma
ECOG performances status 0-1
Measurable/evaluable disease as per mWHO criteria

Exclusion Criteria:

Evidence of active brain metastases
Prior treatment with anti-CTLA-4 or anti-CD137 antibody
Total Bilirubin > 1.5 x ULN and AST or ALT > 2.5 x ULN
Prior Autoimmune disease
Use of immunosuppressing therapies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796991

Contacts

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.

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Medarex

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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

Keywords provided by Bristol-Myers Squibb:

Untreated Advanced Melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Dacarbazine
Paclitaxel
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Carboplatin
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 15, 2009