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ARRY-382, cFMS inhibitor

Phase 1

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

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 Cancer
NCT0131682226
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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")

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Frequently asked questions about ARRY-382, cFMS inhibitor

What is ARRY-382 used for?

ARRY-382 is an investigational small molecule being studied for the treatment of metastatic cancer. It was evaluated in a Phase 1 clinical trial in patients with selected advanced or metastatic cancers. The drug is not approved and remains in clinical development.

What does ARRY-382 target?

ARRY-382 targets the colony-stimulating factor-1 receptor (cFMS), a protein involved in tumor growth and metastasis. By inhibiting cFMS, the drug aims to disrupt signaling pathways that support cancer progression. This mechanism was the focus of its Phase 1 investigation in metastatic cancer.

Who makes ARRY-382?

Pfizer, Inc. (NYSE: PFE) is the developer of ARRY-382. The company sponsored the Phase 1 clinical trial of this investigational small molecule for metastatic cancer. The study has been completed.

What phase is ARRY-382 in?

ARRY-382 is in Phase 1 clinical development. It has completed a Phase 1 trial in patients with advanced or metastatic cancers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ARRY-382 in?

ARRY-382 was studied in one completed Phase 1 trial, NCT01316822, titled "A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers." The trial enrolled 26 patients in the United States and was uncontrolled, non-randomized, and open-label.