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PN-196, 444

Phase 3

Neoplasms | Unknown | Oncology |Pfizer, Inc.|Last Updated: May 4, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

PN-196, 444 · 2 trials · 6 indications

Phase 3 2
NCT00039910Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of ThrombocytopeniaNon-Hodgkin Lymphoma
COMPLETED240 Analytics
NCT00037791Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of ThrombocytopeniaNeoplasms
COMPLETED180 Analytics
PHASE3COMPLETED
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Non-Hodgkin LymphomaUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the effectiveness of primary prophylaxis with intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy-induced thrombocytopenia.
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 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 -
(PN-152,243)/PN-196,444DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Patients must have recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL) or Hodgkin's disease and be scheduled for a minimum of 2 cycles of DHAP (Dexamethasone, high-dose Cytarabine and Cisplatin) chemotherapy Exclusion Criteria:...

Countries:United StatesAustraliaFranceGreeceHong KongPolandRussiaSingaporeArgentinaMexico
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Frequently asked questions about PN-196, 444

What is 1 mg, 5 mg, 10 mg used for?

1 mg, 5 mg, 10 mg is an investigational drug being developed by Pfizer, Inc. (PFE). It is being studied for use in neoplasms, non-Hodgkin lymphoma, meningococcal vaccine, growth disorder, hypercholesterolemia, and non-squamous lung cancer. The drug is currently in Phase 1 clinical development.

Who makes 1 mg, 5 mg, 10 mg?

1 mg, 5 mg, 10 mg is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for multiple indications including neoplasms and growth disorder.

What phase is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for conditions such as neoplasms, non-Hodgkin lymphoma, and growth disorder.

What clinical trials is 1 mg, 5 mg, 10 mg in?

1 mg, 5 mg, 10 mg has been studied in clinical trials including NCT00037791 and NCT00039910, which evaluated its safety and efficacy in preventing thrombocytopenia in patients with neoplasms and lymphoma. These trials were Phase 3 and have been completed.

Is 1 mg, 5 mg, 10 mg the same as PN-152,243?

1 mg, 5 mg, 10 mg is associated with the investigational drug PN-152,243, also referred to as PN-196,444. Clinical trials such as NCT00037791 and NCT00039910 studied the safety and efficacy of PN-152,243/PN-196,444 in preventing thrombocytopenia.