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ARRY-380, HER2 inhibitor

Phase 1

Cancer | Small Molecules | Oncology |Pfizer, Inc.|Trials Updated: May 7, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

ARRY-380, HER2 inhibitor clinical trials

ARRY-380, HER2 inhibitor · 1 trial · 1 indication

Phase 1 1
NCT00650572A Study of ARRY-380 in Patients With Advanced HER2+ CancerCancer
COMPLETED50 Analytics
PHASE1COMPLETED
A Study of ARRY-380 in Patients With Advanced HER2+ Cancer
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
Part 1, one year
Characterize the pharmacokinetics of the study drug.
Part 2, one year
Assess amplification/expression of HER2 in archival and tumor tissues.
Part 2, one year

Secondary Endpoints

Characterize the pharmacokinetics of the study drug.
Part 1, one year
Assess changes in tumor markers.
Part 1, one year
Assess the efficacy of study drug in terms of tumor response and duration of response.
Part 1, one year; Part 2, one year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARRY-380EXPERIMENTAL -

Interventions

NameTypeDescription
ARRY-380, HER2 inhibitor; oralDRUGPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria (Part 1 and Part 2): * Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2). * Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standar...

Countries:United StatesCanada
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Competitive Landscape -Cancer 14 trials

Frequently asked questions about ARRY-380, HER2 inhibitor

What is ARRY-380 used for?

ARRY-380 is an investigational small molecule being studied for the treatment of advanced HER2-positive cancer. It is being developed by Pfizer, Inc. (ticker: PFE) and is currently in Phase 1 clinical development. The drug is designed to target HER2, a protein that is overexpressed in certain cancers, and is being evaluated in patients with advanced HER2+ tumors.

What does ARRY-380 target?

ARRY-380 targets HER2, a receptor tyrosine kinase that is overexpressed in some cancers. By inhibiting HER2, ARRY-380 may block signaling pathways that drive tumor growth. This mechanism is being explored in patients with advanced HER2-positive cancer as part of its clinical development.

Who is developing ARRY-380?

ARRY-380 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is responsible for the clinical development of this oral HER2 inhibitor, which is currently in Phase 1 testing for advanced HER2-positive cancer.

What phase is ARRY-380 in?

ARRY-380 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial, NCT00650572, has been completed and enrolled 50 patients with advanced HER2-positive cancer.

What clinical trials is ARRY-380 in?

ARRY-380 has been studied in one completed Phase 1 clinical trial, NCT00650572, titled "A Study of ARRY-380 in Patients With Advanced HER2+ Cancer." The trial enrolled 50 patients across the United States and Canada and was an uncontrolled, non-randomized study in adults with advanced HER2-positive cancer.

Is ARRY-380 the same as ARRY-380, HER2 inhibitor?

Yes, ARRY-380 is also known as ARRY-380, HER2 inhibitor, and is sometimes referred to as oral ARRY-380. These names refer to the same investigational drug candidate being developed by Pfizer for advanced HER2-positive cancer.