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ARRY-380, HER2 inhibitor

Phase 1

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

Success Probability

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Market & Valuation

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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
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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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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 cancer, specifically in patients with advanced HER2-positive cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does ARRY-380 target?

ARRY-380 is a HER2 inhibitor, meaning it targets the HER2 receptor, which is involved in the growth of certain cancer cells. By inhibiting HER2, the drug aims to interfere with cancer cell proliferation in HER2-positive tumors.

Who is developing ARRY-380?

Pfizer, Inc. (NYSE: PFE) is the developer of ARRY-380. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced HER2-positive cancer.

What phase is ARRY-380 in?

ARRY-380 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The drug is still being studied in early-stage clinical trials to assess its safety and tolerability.

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." This trial enrolled 50 participants and was conducted in the United States and Canada.