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Idarubincin and Amufostine

Phase 1

Leukemia | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 29, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00086099Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid LeukemiaPHASE1 COMPLETED 54Jul 1, 2004Feb 1, 2006Jan 29, 200919 United States, Israel
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Study Endpoints
Primary Endpoints
Clinically significant hematologic and non-hematologic toxicities associated with idarubicin administration
30 days after last dose
Incidence rate of amifostine-associated hypotension results in amifostine dose reduction, discontinuation of amifostine, or causes the development of serious cardiovascular or cerebrovascular events will be estimated
30 days after last dose
Secondary Endpoints
Duration of Complete Remission
Estimated by analysis cohort using Kaplan-Mier Method
Overall Survival
19 mos. after last patient entered or randomized (whichever was earlier).
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALIdarubicin plus amifostine
2EXPERIMENTALIdarubincin
Interventions
NameTypeDescription
Idarubincin and Amufostine (Ethyol)DRUGStarting doses of Idarubincin(12,18 mg/m2 to 21 mg/m2), ara-C, plus amofostine (N-36)
IdarubincinDRUGIdarubincin (12mg/m2) and ara-C(N-18)
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Adult men and women of at least 60 years of age at the time of entry or randomization; * Histologically proven AML with at least 20% myeloblasts based on bone marrow aspiration and biopsy performed within 5 days prior to entry or randomization; History of prior MDS allowed pro...

Countries:United StatesIsrael
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Competitive Landscape -Leukemia 332 trials
CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN8PHASE3Blinatumomab, Low-intensity chemotherapy regimen, HyperCVAD, Omitted Doxorubicin, Omitted Vincristine+Dexamethasone pulses
Eli Lilly and CompanyLLY10PHASE3Pirtobrutinib, Idelalisib, Bendamustine, Rituximab, Venetoclax
AstraZeneca PLCAZN20PHASE3Acalabrutinib, Rituximab, Chlorambucil, Venetoclax, Obinutuzumab
Merck & Co., Inc.MRK7PHASE3Nemtabrutinib, Fludarabine, Cyclophosphamide, Bendamustine, Rituximab
BeOne Medicines Ltd. Sponsored ADRONC14PHASE3Sonrotoclax, Zanubrutinib, Venetoclax, Obinutuzumab, Bendamustine
AbbVie, Inc.ABBV24PHASE3Venetoclax, Acalabrutinib, Obinutuzumab, Fludarabine, Cytarabine
Novartis AG Sponsored ADRNVS21PHASE3Imatinib, Nilotinib, Bosutinib, Dasatinib, Asciminib
Johnson & JohnsonJNJ12PHASE3Ibrutinib, Venetoclax, Chlorambucil, Obinutuzumab, Bleximenib
Nurix Therapeutics, Inc.NRIX5PHASE3NX-5948, Pirtobrutinib, venetoclax, rituximab, obinutuzumab
Kura Oncology, Inc.KURA5PHASE3Ziftomenib, Venetoclax, Azacitidine, Daunorubicin, Cytarabine
Syndax Pharmaceuticals IncSNDX4PHASE3Revumenib, Intensive Chemotherapy Regimen, revumenib, cobicistat, SNDX-5613
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, CC-486, AG-120, AG-221, BMS-986497
Pfizer Inc.PFE6PHASE2Gemtuzumab ozogamicine - Cytarabine - Gilteritinib, Inotuzumab ozogamicin, ALLR3, SEA-CD70, azacitidine
Incyte CorporationINCY6PHASE2Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C, Conditioning Regimen D
Tango Therapeutics, Inc.TNGX7PHASE3AG-120, Azacitidine, Ivosidenib, Ivosidenib + azacitidine, BN104 monotherapy
Ascentage Pharma Group International Unsponsored ADRAAPG11PHASE3Olverembatinib, Imatinib, Lisaftoclax, Acalabrutinib, Fludarabine
Actinium PharmaceuticalsATNM2PHASE3Iomab-B, Conventional Care, 131I-apamistamab, Fludarabine, Cyclophosphamide
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