Skip to main content
OpenTrials
Completed

NCT Number: NCT00038311

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

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 an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy

Exclusion criteria

  • Patients must not have active bleeding (exclusions do apply) or history of platelet disorder

Treatment and study plan

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

Drug

Primary outcomes

  1. To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.

Secondary outcomes

  1. Identify the effect of rhTPO on the number of platelet transfusions.

  2. Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO prophylaxis.

  3. Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia.

  4. Assess the likelihood that patients were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.

  5. Assess the safety of multiple IV doses of rhTPO.

  6. Determine the occurrence and clinical implications of any anti-TPO antibodies.

  7. Assess the antitumor activity of AI chemotherapy.

  8. Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.

  9. Evaluate the impact of rhTPO prophylaxis on patient quality of life.

  10. Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia Administered to Patients With High-Risk Sarcoma Receiving Intensive Chemotherapy (Adriamycin and Ifosfamide (AI))

Important dates

Study start
2000
Study completion
2003
First posted
May 31, 2002
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.