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Palifermin 6 x 60 μg/kg/day

Phase 1

Leukemia | Small molecule | Oncology |Amgen Inc.|Last Updated: Oct 24, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

Palifermin 6 x 60 μg/kg/day · 1 trial · 3 indications

Phase 1 1
NCT00070616Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell SupportLeukemia
COMPLETED25 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

To characterize the PK profile of 3 daily intravenous (IV) doses of rHuKGF before total body irradiation (TBI) / high-dose chemotherapy conditioning treatment and after PBPC transplantation

Secondary Endpoints

To assess the safety and tolerability of rHuKGF in subjects with hematologic malignancies undergoing TBI and high-dose chemotherapy followed by PBPC transplantation.
To assess oral mucositis in subjects receiving rHuKGF.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Palifermin 6 x 60 μg/kg/dayEXPERIMENTALThe first 3 consecutive daily doses were administered before the initiation of conditioning therapy (study days -11, -10, and -9); 3 additional consecutive daily doses were administered after administration of radiotherapy, chemotherapy and PBPC transplantation (study days 0, 1, and 2).
Palifermin 2 x 180 μg/kg/dayEXPERIMENTALThe first dose was administered on study day -11, 3 days before the initiation of conditioning therapy, and the second dose was given on day 0 after administration of radiotherapy, chemotherapy and the PBPC infusion

Interventions

NameTypeDescription
Palifermin 6 x 60 μg/kg/dayDRUG -
Palifermin 2 x 180 μg/kg/dayDRUG -
radiotherapyRADIATION -
ChemotherapyDRUG -
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Eligibility Criteria

Age Range18 Years to 76 Years
SexALL
Healthy VolunteersNo

* Patients diagnosed with Non-Hodgkin's Lymphoma, Hodgkin's Disease, Leukemia and Myeloma. - Eligible for treatment with radiation therapy and chemotherapy followed by blood stem cell support.

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Competitive Landscape -Leukemia 327 trials

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CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN8PHASE3Blinatumomab, Low-intensity chemotherapy regimen
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BeOne Medicines Ltd. Sponsored ADRONC13PHASE3Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab
AbbVie, Inc.ABBV24PHASE3Venetoclax
AstraZeneca PLCAZN18PHASE3Acalabrutinib, Rituximab, Chlorambucil
Merck & Co., Inc.MRK7PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
Johnson & JohnsonJNJ12PHASE3Ibrutinib, Venetoclax, Chlorambucil, Obinutuzumab
Novartis AG Sponsored ADRNVS21PHASE3Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
Kura Oncology, Inc.KURA5PHASE3Ziftomenib, Venetoclax, Azacitidine, Daunorubicin, Cytarabine
Nurix Therapeutics, Inc.NRIX5PHASE3NX-5948, Pirtobrutinib
Syndax Pharmaceuticals IncSNDX4PHASE3Revumenib, Intensive Chemotherapy Regimen
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE3Ponatinib, Imatinib, Vincristine, Dexamethasone, Cytarabine
SELLAS Life Sciences Group, Inc.SLS1PHASE3Galinpepimut-S, Azacitidine, Venetoclax, Decitabine, Cytarabine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
Bristol-Myers Squibb CompanyBMY7PHASE2Azacitidine
Pfizer Inc.PFE6PHASE2Gemtuzumab ozogamicine- Cytarabine- Gilteritinib
Ascentage Pharma Group International Unsponsored ADRAAPG11PHASE3Olverembatinib
Tango Therapeutics, Inc.TNGX7PHASE3AG-120, Azacitidine
Incyte CorporationINCY6PHASE2Ruxolitinib
Actinium Pharmaceuticals, Inc. (Delaware)ATNM2PHASE3Iomab-B, Conventional Care
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Frequently asked questions about Palifermin 6 x 60 μg/kg/day

What is Palifermin 6 x 60 μg/kg/day used for?

Palifermin 6 x 60 μg/kg/day is an investigational small molecule being studied for use in leukemia. It is also being evaluated in patients with lymphoma and myeloma. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes Palifermin 6 x 60 μg/kg/day?

Palifermin 6 x 60 μg/kg/day is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with blood cancers.

What phase is Palifermin 6 x 60 μg/kg/day in?

Palifermin 6 x 60 μg/kg/day is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed for this drug.

What clinical trials is Palifermin 6 x 60 μg/kg/day in?

Palifermin 6 x 60 μg/kg/day has one completed clinical trial, NCT00070616, titled 'Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support.' This Phase 1 study enrolled 25 participants aged 18 years and older with leukemia, lymphoma, or myeloma.

Is Palifermin 6 x 60 μg/kg/day the same as Palifermin?

Palifermin 6 x 60 μg/kg/day is a specific dosing regimen of palifermin, which is the drug's active ingredient. The name indicates a dose of 60 micrograms per kilogram per day, administered six times. The drug is being studied for its effects in patients with blood cancers.