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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00037791
First received: May 21, 2002
Last updated: November 8, 2006
Last verified: September 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Pfizer Investigational Site
Berkeley, California, United States, 94704
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Los Angeles, California, United States, 90067
Pfizer Investigational Site
Los Angeles, California, United States, 90033-0804
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Argentina
Pfizer Investigational Site
Buenos Aires, Capital Federal, Argentina, 1406
Pfizer Investigational Site
Buenos Aires, Capital Federal, Argentina, 1114
Mexico
Pfizer Investigational Site
Mexico City, DF, Mexico, 02990
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Thrombocytopenia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Blood Platelet Disorders

ClinicalTrials.gov processed this record on August 28, 2014