Study to Compare Two Formulations of CP-675,206 Monoclona... | NCT00431275

Studies
Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody

NCT00431275

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 6, 2012Estimated

Enrollment

85Actual

Phase

Phase 1

Conditions

Melanoma

Interventions

CP-675,206
CP-675,206

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Feb 2, 2007

First Submission Date that Met QC Criteria

Feb 2, 2007

First Posted Date

Feb 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2012

Last Update Posted Date

Jun 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Commercial Formulation	Experimental	Commercial Formulation	Drug: CP-675,206
Current Formulation	Experimental	Current Formulation	Drug: CP-675,206

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CP-675,206	Drug	CP-675,206 15 mg/kg iv single dose on Day 1	Commercial Formulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics: maximum plasma concentration of CP-675,206		1 hour
Pharmacokinetics: AUC, defined as the area under the concentration -time curve		Time 0 to Day 85

Secondary Outcomes

Measure	Description	Time Frame
Human-anti-human antibodies		1 year
Adverse events		1 year
Safety laboratory tests

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Scottsdale	Arizona	85260	United States
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C520704	tremelimumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided