Recent Updates
Recently added Catalysts

ARRY-380, HER2 inhibitor

Phase 1

Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 7, 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Cancer 5 trials

Unlock Competitive Intelligence

Frequently asked questions about ARRY-380, HER2 inhibitor

What is ARRY-380?

ARRY-380 is an oral small molecule HER2 inhibitor being developed by Pfizer for the treatment of cancer. It is an investigational agent that has been studied in patients with advanced HER2-positive cancer. ARRY-380 is also known as an oral HER2 inhibitor.

What is ARRY-380 used for?

ARRY-380 is being studied for use in cancer, specifically in patients with advanced HER2-positive cancer. It is an investigational therapy and has not been approved for any indication. Its development is focused on oncology.

What does ARRY-380 target?

ARRY-380 targets HER2, a receptor tyrosine kinase that is overexpressed in certain cancers. By inhibiting HER2, ARRY-380 may block signaling pathways that drive tumor growth. It is an oral small molecule designed to selectively inhibit HER2.

Who is developing ARRY-380?

ARRY-380 is being developed by Pfizer, Inc. (ticker: PFE). Pfizer is responsible for the clinical development of this oral HER2 inhibitor.

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 has been completed.

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 in the United States and Canada.