NCT00038311

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2000

Geographic Reach
1 country

6 active sites

Status
completed

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

September 1, 2000

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

First QC Date

May 30, 2002

Last Update Submit

April 30, 2015

Conditions

Sarcoma

Outcome Measures

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 (10)

  • Identify the effect of rhTPO on 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 were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.

  • Assess the safety of multiple IV doses of rhTPO.

  • +5 more secondary outcomes

Interventions

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

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pfizer Investigational Site

Los Angeles, California, 90067, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60637, United States

Location

Pfizer Investigational Site

Park Ridge, Illinois, 60068, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19106, United States

Location

Pfizer Investigational Site

Radnor, Pennsylvania, 19087, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

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 30, 2002

First Posted

May 31, 2002

Study Start

September 1, 2000

Study Completion

March 1, 2003

Last Updated

May 4, 2015

Record last verified: 2015-04

Locations

US(6)