Know Cancer

or
forgot password

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))


Phase 3
13 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

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))


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

444-ONC-0003-020

NCT ID:

NCT00038311

Start Date:

September 2000

Completion Date:

March 2003

Related Keywords:

  • Sarcoma
  • Thrombocytopenia
  • Sarcoma

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535