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ARRY-382, cFMS inhibitor

Phase 1

Metastatic Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 21, 2020

Target and mechanism

Molecular targetCSF1R
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

ARRY-382, cFMS inhibitor · 1 trial · 1 indication

Phase 1 1
NCT01316822A Study of ARRY-382 in Patients With Selected Advanced or Metastatic CancersMetastatic Cancer
COMPLETED26 Analytics
PHASE1COMPLETED
A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers
Metastatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms.
Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
Establish the maximum tolerated dose (MTD) of study drug.
The MTD will be based on Cycle 1 (28 days).
Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites.
Safety will be characterized for the duration of time that each patient stays on study; estimated one year.

Secondary Endpoints

Assess the efficacy of study drug in terms of incidence of response rate and duration of response.
All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARRY-382EXPERIMENTAL -

Interventions

NameTypeDescription
ARRY-382, cFMS inhibitor; oralDRUGmultiple dose, escalating
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * A histologically or cytologically confirmed diagnosis of advanced or metastatic solid cancer refractory to standard treatment, for which no standard therapy is available or for which the patient refuses standard therapy. * Measurable disease or evaluable, nonmeasurable dis...

Countries:United States
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Competitive Landscape -Cancer 5 trials (matched to "Metastatic Cancer")

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Frequently asked questions about ARRY-382, cFMS inhibitor

What is ARRY-382 used for?

ARRY-382 is an investigational oral small molecule being studied in patients with selected advanced or metastatic cancers. It was evaluated in a Phase 1 study in adults with metastatic cancer. It is not an approved therapy and remains in clinical development for oncology indications.

What does ARRY-382 target?

ARRY-382 targets CSF1R, also known as cFMS, the colony stimulating factor 1 receptor. It is a small molecule inhibitor of that receptor. Targeting CSF1R is intended to affect signaling pathways involved in the tumor microenvironment and macrophage biology in advanced or metastatic cancers.

Who is developing ARRY-382?

ARRY-382 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer holds the development program for this oral CSF1R inhibitor, which has been studied in patients with selected advanced or metastatic cancers.

What phase is ARRY-382 in?

ARRY-382 is in Phase 1 development. It is an investigational agent and has not been approved by the FDA. The single Phase 1 study of ARRY-382 has been completed, and no trials are currently listed as active.

What clinical trials is ARRY-382 in?

ARRY-382 was studied in one Phase 1 trial, NCT01316822, titled A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers. That trial enrolled 26 patients in the United States, was uncontrolled, and has been completed. No active trials are listed.

Is ARRY-382 the same as cFMS inhibitor?

Yes. ARRY-382 is also referred to as a cFMS inhibitor, and the oral formulation is described as ARRY-382, cFMS inhibitor; oral. cFMS is another name for CSF1R, the molecular target of this small molecule. These names refer to the same investigational compound developed by Pfizer.