Recent Updates
Recently added Catalysts

Idarubincin and Amufostine

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Idarubincin and Amufostine clinical trials

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).
Unlock Study Endpoints

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)
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Leukemia 435 trials

Unlock Competitive Intelligence

Frequently asked questions about Idarubincin and Amufostine

What is idarubincin and amufostine used for?

Idarubincin and amufostine is an investigational combination being studied in leukemia, specifically acute myeloid leukemia. It pairs idarubicin, a small molecule chemotherapy agent, with amifostine, also known as Ethyol. The combination was evaluated in older patients with acute myeloid leukemia, a blood cancer affecting the bone marrow.

Who is developing idarubincin and amufostine?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of the idarubincin and amufostine combination. The company sponsored the clinical research evaluating this regimen in leukemia. AstraZeneca is a global pharmaceutical company with an oncology portfolio that includes both chemotherapy and supportive care agents.

What phase is idarubincin and amufostine in?

Idarubincin and amufostine is in Phase 1 clinical development. The single registered trial of this combination was a Phase 1 study, and it has been completed. The drug combination is investigational and has not been approved by the FDA for any indication.

What clinical trials is idarubincin and amufostine in?

Idarubincin and amufostine has been studied in one clinical trial, NCT00086099, titled a study evaluating the addition of amifostine (Ethyol) to idarubicin and cytosine arabinoside in older patients with acute myeloid leukemia. The Phase 1 trial enrolled 54 patients, was controlled and randomized, and was conducted in the United States and Israel.

Is idarubincin and amufostine the same as Ethyol?

Amufostine is also known as amifostine, sold under the brand name Ethyol. Idarubincin and amufostine is the combination of idarubicin with amifostine, so Ethyol refers to only one component of the regimen, not the combination itself. Searches for idarubincin and amufostine (Ethyol) refer to this same drug combination.

What was studied in the idarubincin and amufostine trial?

The completed Phase 1 trial NCT00086099 evaluated adding amifostine, also called Ethyol, to idarubicin and cytosine arabinoside in older patients with acute myeloid leukemia. It enrolled 54 patients aged 60 years and older, included both sexes, and was a controlled, randomized study conducted in the United States and Israel.