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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 in oncology for advanced myelodysplastic syndromes (MDS), advanced solid tumors, multiple myeloma, and plasma cell leukemia. It has been evaluated in Phase 1 clinical trials in patients with these advanced or relapsed/refractory hematologic and solid tumor cancers.

What does ARRY-520 target?

ARRY-520 is a KSP inhibitor, also known as an Eg5 inhibitor. KSP (Eg5) is a kinesin spindle protein required for mitotic spindle formation and cell division. By inhibiting KSP, ARRY-520 interferes with mitosis in cancer cells. It is a small molecule administered intravenously.

Who is developing ARRY-520?

ARRY-520 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The compound originated as a kinesin spindle protein (KSP/Eg5) inhibitor and is being advanced by Pfizer in 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 investigational and has not been approved by the FDA. The Phase 1 program has evaluated the agent in patients with relapsed or refractory multiple myeloma, plasma cell leukemia, advanced myeloid leukemia, advanced MDS, and advanced solid tumors.

What clinical trials is ARRY-520 in?

ARRY-520 has been studied in completed Phase 1 trials including NCT01248923 (with bortezomib and dexamethasone in relapsed/refractory multiple myeloma), NCT00821249 (relapsed or refractory multiple myeloma), NCT00637052 (advanced myeloid leukemia), and NCT00462358 (advanced solid tumors). All were conducted in the United States.

Is ARRY-520 the same as the KSP(Eg5) inhibitor?

Yes. ARRY-520 is also known as a KSP(Eg5) inhibitor and is given intravenously. KSP, or Eg5, is a kinesin spindle protein targeted by the drug. These names refer to the same investigational small molecule compound developed by Pfizer.