Use of 852A in Metastatic Cutaneous Melanoma. | NCT00189332

Studies
Use of 852A in Metastatic Cutaneous Melanoma.

NCT00189332

Sponsor

Pfizer

Status

Completed

Last Update Posted

Oct 27, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Melanoma
Unresectable Metatstatic Cutaneous Melanoma

Interventions

852A

Countries

France
Germany
Switzerland

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

Oct 2008

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

Feb 2005

Primary Completion Date

Aug 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

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

Oct 24, 2008

Last Update Posted Date

Oct 27, 2008Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
852A	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
assessing antitumor activity of 852A intravenous bolus injection administered 3 times a week for 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
to assess the safety of the dosage regiment over 12 weeks
to obtain preliminary data regarding the safety and long term efficacy of 852A in subjects treated with the drug for more than 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced melanoma not responding to 1st line chemotherapy
Histological evidence of melanoma
Measurable disease according to RECIST criteria
ECOG performance status less than or equal to 2
Life expectancy 6 months or more
Normal organ and bone marrow function as defined by hematological and serum chemistry limits
Adequate contraception for females of childbearing potential

Exclusion Criteria:

Stage IV disease which has previously progressed during interferon treatment.
Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
History of uncontrolled seizure disorders
Uncontrolled coagulation disorders.
History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
History of uncontrolled intercurrent or chronic illness
Concurrent malignancies.
Brain metastases.
HIV positive.
Prolonged QTc interval
Uncontrolled intercurrent or chronic illnesses.
Pregnant or lactating women

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

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Hotel Dieu, 1, Pace de l' Hôpital,		Lyon			France
Hôpital Ste Marguerite,Service de Dermatologie

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma
D009369	Neoplasms

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