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PN-152, 243/PN-196, 444

Phase 3

Sarcoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 4, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

PN-152, 243/PN-196, 444 · 1 trial · 1 indication

Phase 3 1
NCT00038311Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of ThrombocytopeniaSarcoma
COMPLETED120 Analytics
PHASE3COMPLETED
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
SarcomaUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
PN-152,243)/PN-196,444DRUG -
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Eligibility Criteria

Age Range13 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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

Countries:United States
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Frequently asked questions about PN-152, 243/PN-196, 444

What is PN-152,243/PN-196,444 used for?

PN-152,243/PN-196,444 is an investigational small molecule being studied for the prevention of thrombocytopenia in patients with sarcoma. It is being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 3 clinical development.

Who makes PN-152,243/PN-196,444?

PN-152,243/PN-196,444 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and efficacy in preventing thrombocytopenia in patients with sarcoma.

What phase is PN-152,243/PN-196,444 in?

PN-152,243/PN-196,444 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial has been completed to assess its safety and efficacy in preventing thrombocytopenia in sarcoma patients.

What clinical trials is PN-152,243/PN-196,444 in?

PN-152,243/PN-196,444 has one completed Phase 3 clinical trial, NCT00038311, titled "Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia." The trial enrolled 120 participants with sarcoma in the United States and was completed.

Is PN-152,243 the same as PN-196,444?

PN-152,243 and PN-196,444 are both names used for the same investigational drug, referred to as PN-152,243/PN-196,444. This drug is being studied for the prevention of thrombocytopenia in patients with sarcoma.