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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00037791

Purpose

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.

Condition	Intervention	Phase
Neoplasms Thrombocytopenia Multiple Myeloma Lymphoma, Malignant	Drug: (PN-152,243)/PN-196,444	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Blood Transfusion and Donation Cancer Lymphoma Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Pfizer:

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

Estimated Enrollment:	180
Study Start Date:	December 1999
Estimated Study Completion Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037791

Locations

United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90067
Pfizer Investigational Site
Los Angeles, California, United States, 90033-0804
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Berkeley, California, United States, 94704
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Argentina, Capital Federal
Pfizer Investigational Site
Buenos Aires, Capital Federal, Argentina, 1406
Pfizer Investigational Site
Buenos Aires, Capital Federal, Argentina, 1114
Mexico, DF
Pfizer Investigational Site
Mexico City, DF, Mexico, 02990

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	98-OTPO-005
Study First Received:	May 21, 2002
Last Updated:	November 8, 2006
ClinicalTrials.gov Identifier:	NCT00037791
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma

Thrombocytopathy
Lymphatic Diseases
Hemorrhagic Disorders
Thrombocytopenia
Multiple myeloma
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009