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

Primary Purpose

Neoplasms, Thrombocytopenia, Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
(PN-152,243)/PN-196,444
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

To evaluate the effectiveness of two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.

Secondary Outcome Measures

Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and the number of platelet transfusions
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle
Assess the safety of multiple intravenous doses of rhTPO
Determine the occurrence and clinical implications of any anti-rhTPO antibodies
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Evaluate the impact of rhTPO administration on patient quality of life

Full Information

First Posted
May 21, 2002
Last Updated
November 8, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00037791
Brief Title
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Official Title
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Patients Receiving Myelosuppressive Treatment Regimens Requiring Platelet Transfusion Support.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Thrombocytopenia, Multiple Myeloma, Lymphoma, Malignant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
(PN-152,243)/PN-196,444
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.
Secondary Outcome Measure Information:
Title
Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and the number of platelet transfusions
Title
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis
Title
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
Title
Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle
Title
Assess the safety of multiple intravenous doses of rhTPO
Title
Determine the occurrence and clinical implications of any anti-rhTPO antibodies
Title
Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
Title
Evaluate the impact of rhTPO administration on patient quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
1114
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
1406
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Mexico City
State/Province
DF
ZIP/Postal Code
02990
Country
Mexico

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=98-OTPO-005&StudyName=Safety+and+Efficacy+of+%28PN%2D152%2C243%29%2FPN%2D196%2C444+in+the+Prevention+of+Thrombocytopenia+
Description
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Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia

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