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Use of 852A in Metastatic Cutaneous Melanoma.

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NCT00189332

Last updated on November 21, 2019
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FOR MORE INFORMATION
Study Location
Hôpital Hotel Dieu, 1, Pace de l' Hôpital,
Lyon, , France
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Melanoma, Unresectable Metatstatic Cutaneous Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00189332
Pfizer
Completed
Use of 852A in Metastatic Cutaneous Melanoma.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE Use of 852A in Metastatic Cutaneous Melanoma.
Official Title  ICMJE Pilot Phase II, Open Label, Multicenter, Efficacy and Safety Study of 852A Administered Intravenously to Subjects With Unresectable Metastatic Cutaneous Melanoma.
Brief SummaryPilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Unresectable Metatstatic Cutaneous Melanoma
Intervention  ICMJE Drug: 852A
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)		28
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2006
Actual Primary Completion DateAugust 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00189332
Other Study ID Numbers  ICMJE 1527-852A
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountPfizer
Verification DateOctober 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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