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ARRY-520, KSP inhibitor

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

ARRY-520, KSP inhibitor · 4 trials · 6 indications

Phase 1 4
NCT01248923A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple MyelomaMultiple Myeloma, Plasma Cell Leukemia
COMPLETED55 Analytics
NCT00821249A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple MyelomaMultiple Myeloma
COMPLETED55 Analytics
NCT00637052A Study of ARRY-520 in Patients With Advanced Myeloid LeukemiaAdvanced MDS
COMPLETED36 Analytics
NCT00462358A Study of ARRY-520 in Patients With Advanced CancerAdvanced Solid Tumors
COMPLETED41 Analytics
PHASE1COMPLETED
A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Plasma Cell LeukemiaUnlock trial analytics
PHASE1COMPLETED
A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
Multiple MyelomaUnlock trial analytics
PHASE1COMPLETED
A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
Advanced MDSUnlock trial analytics
PHASE1COMPLETED
A Study of ARRY-520 in Patients With Advanced Cancer
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1
Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF.
Part 1
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of best overall response
Part 2
Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.
Part 1
Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate.
Part 2 and Part 3
Characterize the safety profile of the study drug in combination with dexamethasone in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 3
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
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1 and Part 2

Secondary Endpoints

Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of duration of response, time to progression, treatment-free interval and time to next treatment.
Part 1 and Part 2
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 2
Assess the pharmacokinetic (PK) drug interactions between ARRY-520 and bortezomib in terms of plasma concentration-time profiles.
Part 2
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARRY-520 (Schedule 1) + bortezomib + G-CSFEXPERIMENTAL -
ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSFEXPERIMENTAL -
ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSFEXPERIMENTAL -
ARRY-520EXPERIMENTAL -
ARRY-520 + G-CSF supportEXPERIMENTAL -
ARRY-520 + dexamethasone + G-CSF supportEXPERIMENTAL -

Interventions

NameTypeDescription
ARRY-520, KSP(Eg5) inhibitor; intravenousDRUGPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Bortezomib, proteasome inhibitor; intravenous or subcutaneousDRUGPart 1: standard of care; Part 2: standard of care determined in Part 1.
Dexamethasone, steroid; oralDRUGPart 1: standard of care; Part 2: standard of care determined in Part 1.
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousDRUGPart 1: standard of care; Part 2: standard of care.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Key Inclusion Criteria (Part 1 and Part 2): * Confirmed relapsed or refractory MM (measurable disease) or PCL. * Prior treatment regimens for Part 1: Patients should have received at least 2 prior treatment regimens. Prior treatment must have included at least one full cycle of a proteasome inhibit...

Countries:United States
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Frequently asked questions about ARRY-520, KSP inhibitor

What is ARRY-520 used for?

ARRY-520 is an investigational small molecule being studied for the treatment of multiple myeloma, advanced solid tumors, plasma cell leukemia, and advanced MDS. It is being developed by Pfizer, Inc. (NYSE: PFE) and is currently in Phase 1 clinical development for these oncology indications.

What does ARRY-520 target?

ARRY-520 targets the kinesin spindle protein (KSP), a motor protein essential for cell division. By inhibiting KSP, ARRY-520 is designed to disrupt mitosis in cancer cells. This mechanism is being evaluated in Phase 1 trials for multiple myeloma and other advanced cancers.

Who makes ARRY-520?

Pfizer, Inc. (NYSE: PFE) is developing ARRY-520. The drug is an investigational small molecule currently in Phase 1 clinical trials for oncology indications including multiple myeloma and advanced solid tumors.

What phase is ARRY-520 in?

ARRY-520 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Multiple Phase 1 trials have been completed, studying the drug in patients with advanced solid tumors, advanced myeloid leukemia, and multiple myeloma.

What clinical trials is ARRY-520 in?

ARRY-520 has been studied in several completed Phase 1 trials, including NCT00462358 in advanced solid tumors, NCT00637052 in advanced MDS and acute myeloid leukemia, NCT00821249 in relapsed or refractory multiple myeloma, and NCT01248923 combining ARRY-520 with bortezomib and dexamethasone in multiple myeloma.

Is ARRY-520 the same as filanesib?

ARRY-520 is also known as filanesib. It is a kinesin spindle protein inhibitor being developed by Pfizer for multiple myeloma and other cancers. The drug has been evaluated in Phase 1 clinical trials under both names.