Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

NCT ID: NCT00037791

Last Updated: 2006-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2002-09-30

Brief Summary

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Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.

Detailed Description

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Conditions

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Neoplasms Thrombocytopenia Multiple Myeloma Lymphoma, Malignant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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(PN-152,243)/PN-196,444

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support

Exclusion Criteria

* Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Berkeley, California, United States

Site Status

Pfizer Investigational Site

La Jolla, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

New Orleans, Louisiana, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Pfizer Investigational Site

Mexico City, Mexico City, Mexico

Site Status

Countries

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United States Argentina Mexico

Related Links

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Other Identifiers

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98-OTPO-005

Identifier Type: -

Identifier Source: org_study_id