Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
1 other identifier
interventional
180
3 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 1999
Typical duration for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
CompletedFirst Submitted
Initial submission to the registry
May 21, 2002
CompletedFirst Posted
Study publicly available on registry
May 22, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2002
CompletedNovember 9, 2006
September 1, 2006
May 21, 2002
November 8, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (9)
Pfizer Investigational Site
Berkeley, California, 94704, United States
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
Los Angeles, California, 90033-0804, United States
Pfizer Investigational Site
Los Angeles, California, 90067, United States
Pfizer Investigational Site
New Orleans, Louisiana, 70115, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., 1114, Argentina
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., 1406, Argentina
Pfizer Investigational Site
Mexico City, Mexico City, 02990, Mexico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 21, 2002
First Posted
May 22, 2002
Study Start
December 1, 1999
Study Completion
September 1, 2002
Last Updated
November 9, 2006
Record last verified: 2006-09