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Idarubincin and Amufostine

Phase 1

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

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Idarubincin and Amufostine · 1 trial · 2 indications

Phase 1 1
NCT00086099Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid LeukemiaLeukemia
COMPLETED54 Analytics
PHASE1COMPLETED
Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia
LeukemiaUnlock trial analytics

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 to 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 327 trials

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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 Idarubincin and Amufostine

What is Idarubincin and Amufostine used for?

Idarubincin and Amufostine is an investigational combination therapy being studied for the treatment of leukemia, specifically acute myeloid leukemia, in older patients aged 60 years and above. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Idarubincin and Amufostine?

Idarubincin and Amufostine is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate this combination therapy for the treatment of leukemia.

What phase is Idarubincin and Amufostine in?

Idarubincin and Amufostine is in Phase 1 clinical development. It is an investigational drug combination that has not yet received regulatory approval. The Phase 1 trial has been completed, and the therapy remains under investigation for its safety and efficacy in treating leukemia.

What clinical trials is Idarubincin and Amufostine in?

Idarubincin and Amufostine has been studied in one clinical trial with the identifier NCT00086099. This Phase 1 study evaluated the addition of amifostine to idarubicin and cytosine arabinoside in older patients with acute myeloid leukemia. The trial was completed and enrolled 54 participants in the United States and Israel.

Is Idarubincin and Amufostine the same as amifostine and idarubicin?

Idarubincin and Amufostine refers to a combination therapy that includes amifostine and idarubicin, along with cytosine arabinoside. The clinical trial NCT00086099 evaluated the addition of amifostine to a regimen of idarubicin and cytosine arabinoside in older patients with acute myeloid leukemia.