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ARRY-520, KSP inhibitor;

Phase 1

Advanced MDS | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Feb 8, 2021

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00637052A Study of ARRY-520 in Patients With Advanced Myeloid LeukemiaPHASE1 COMPLETED 36 — — Mar 18, 2008Jun 21, 2010Feb 8, 20212 United States
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Study Endpoints
Primary Endpoints
Establish the maximum tolerated dose (MTD) of the study drug.
Part 1
Characterize the pharmacokinetics (PK) of the study drug.
Part 1
Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations.
Part 1 and Part 2
Assess the efficacy of the study drug in terms of incidence of complete remission (CR) and hematologic improvement (CRp).
Part 3
Secondary Endpoints
Assess the efficacy of the study drug in terms of incidence of CR and CRp.
Part 1 and Part 2
Characterize the safety profile of the study drug in terms of adverse events, dose limiting toxicity, clinical laboratory tests, weight, electrocardiograms and physical examinations.
Part 3
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Study Design & Arms
AllocationNON_RANDOMIZED
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARRY-520EXPERIMENTAL -
Interventions
NameTypeDescription
ARRY-520, KSP(Eg5) inhibitor; intravenousDRUGPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
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Eligibility Criteria
Age Range17 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria (Part 2): * Patients with either Intermediate-2 or High risk MDS or with AML (\>20% bone marrow blasts) with stable low or normal white blood cell count (WBC). Patients should have failed one prior chemotherapy regimen which should have included a hypomethylating agent. * Eas...

Countries:United States
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