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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 Lymphoma
NCT00039910240
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PHASE3COMPLETED
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia
Neoplasms
NCT00037791180
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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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Competitive Landscape -Myeloproliferative Neoplasms 52 trials (matched to "Neoplasms")

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY5PHASE3Luspatercept, Fedratinib, BMS-986158
AbbVie, Inc.ABBV4PHASE3Navitoclax, ABBV-744, IMGN632
Novartis AG Sponsored ADRNVS3PHASE3Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor
Geron CorporationGERN2PHASE3Imetelstat
Incyte CorporationINCY9PHASE2Ruxolitinib, INCB160058, INCB057643, INCA033989, INCB000928
Merck & Co., Inc.MRK1PHASE3Bomedemstat
GSK plc Sponsored ADRGSK2PHASE2Momelotinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Elritercept
Eli Lilly and CompanyLLY1PHASE1LY3410738
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Damora Therapeutics, Inc.DMRA1PHASE2GB2064
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
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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 studied for use in meningococcal vaccine, non-Hodgkin lymphoma, growth disorder, acute otitis media, hypogonadism, and healthy volunteers. It 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. (NYSE: PFE). The drug is currently in Phase 1 clinical development.

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 and has not been approved by regulatory authorities.

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, NCT00039910, NCT00174421, and NCT01163851. These trials have investigated its use in conditions such as thrombocytopenia, non-Hodgkin lymphoma, growth disorder, and hypercholesterolemia.

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

1 mg, 5 mg, 10 mg is also known as PN-152,243 and PN-196,444 in clinical trials. These names refer to the same investigational drug being developed by Pfizer.