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Filanesib, KSP inhibitor

Phase 2

Advanced Multiple Myeloma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 19, 2020

Target and mechanism

Molecular targetKIF11
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment231

FDA Designations

No designations recorded

Clinical trial landscape

Filanesib, KSP inhibitor · 2 trials · 1 indication

Phase 2 2
NCT02092922A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)Advanced Multiple Myeloma
COMPLETED154 Analytics
NCT01989325A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple MyelomaAdvanced Multiple Myeloma
COMPLETED77 Analytics
PHASE2COMPLETED
A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
Advanced Multiple MyelomaUnlock trial analytics
PHASE2COMPLETED
A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
Advanced Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

In patients with low Baseline alpha 1-acid glycoprotein (AAG), assess the efficacy of the study drug in terms of objective response rate.
up to 2 years
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
18 months

Secondary Endpoints

In patients with high Baseline AAG, assess the efficacy of the study drug in terms of objective response rate.
up to 2 years
In all patients, assess the efficacy of the study drug in terms of duration of response.
up to 2 years
In all patients, assess the efficacy of the study drug in terms of progression-free survival.
up to 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FilanesibEXPERIMENTAL -
Carfilzomib + FilanesibEXPERIMENTALSingle agent + Carfilzomib arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information. Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
CarfilzomibEXPERIMENTALSingle agent arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.

Interventions

NameTypeDescription
Filanesib, KSP (Eg5) inhibitor; intravenousDRUGmultiple dose, single schedule
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneousDRUGstandard of care
Carfilzomib, proteasome inhibitor; intravenousDRUGmultiple dose, single schedule
Filanesib, KSP(Eg5) inhibitor; intravenousDRUGmultiple dose, single schedule
Dexamethasone, steroid; oral or intravenousDRUGas indicated, per the carfilzomib prescribing information
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites60

Key Inclusion Criteria: * Patients with confirmed multiple myeloma whose treatment history must include all of the following: 1. Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy). 2. Received at l...

Countries:United StatesBelgiumCanadaFranceGermanyGreeceSpainUnited Kingdom
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Frequently asked questions about Filanesib, KSP inhibitor

What is filanesib used for?

Filanesib is an investigational small molecule being studied for advanced multiple myeloma. It has been evaluated in Phase 2 clinical trials in patients with relapsed or refractory disease. It is not approved for commercial use and remains in clinical development.

What does filanesib target?

Filanesib targets KIF11, also known as kinesin spindle protein or Eg5. It acts as an inhibitor of this target. KIF11 is involved in mitotic spindle formation, and inhibiting it disrupts cell division in dividing cells such as myeloma cells.

Who is developing filanesib?

Pfizer, Inc. is the developer of filanesib. The company trades on the New York Stock Exchange under the ticker PFE. Pfizer has sponsored the Phase 2 clinical trials evaluating filanesib in advanced multiple myeloma.

What phase is filanesib in?

Filanesib is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Two Phase 2 trials have been completed, and no trials are currently active.

What clinical trials is filanesib in?

Filanesib has been studied in two completed Phase 2 trials. NCT02092922, the AfFIRM trial, evaluated filanesib in relapsed or refractory multiple myeloma with 154 patients across the United States and Europe. NCT01989325 studied filanesib with carfilzomib in 77 patients in the United States.

Is filanesib the same as ARRY-520?

Yes, filanesib is also known as ARRY-520. It is additionally referred to as a KSP inhibitor or KSP (Eg5) inhibitor, and formulations described as intravenous. These names refer to the same investigational agent targeting KIF11.