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ARRY-334543, EGFR/ErbB2 inhibitor

Phase 1

Advanced Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 14, 2020

Success Probability

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Trial Design

UNCONTROLLED
Total Trials5
Total Enrollment203

FDA Designations

No designations recorded

Clinical trial landscape

ARRY-334543, EGFR/ErbB2 inhibitor · 5 trials · 2 indications

Phase 1 5
NCT00862524A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic CancerAdvanced Cancer
COMPLETED20 Analytics
NCT00833326A Study of ARRY-334543 and Docetaxel in Patients With Advanced CancerAdvanced Cancer
COMPLETED27 Analytics
NCT00710736A Study of ARRY-334543 and Capecitabine in Patients With Advanced CancerAdvanced Cancer
COMPLETED29 Analytics
NCT00637702A Study of ARRY-334543 in Patients With Advanced CancerAdvanced Cancer
COMPLETED31 Analytics
NCT00278902A Study of ARRY-334543 in Patients With Advanced CancerAdvanced Cancer
COMPLETED96 Analytics
PHASE1COMPLETED
A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer
Advanced CancerUnlock trial analytics
PHASE1COMPLETED
A Study of ARRY-334543 and Docetaxel in Patients With Advanced Cancer
Advanced CancerUnlock trial analytics
PHASE1COMPLETED
A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer
Advanced CancerUnlock trial analytics
PHASE1COMPLETED
A Study of ARRY-334543 in Patients With Advanced Cancer
Advanced CancerUnlock trial analytics
PHASE1COMPLETED
A Study of ARRY-334543 in Patients With Advanced Cancer
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.
Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1
Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite.
Part 1
Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks.
Part 2
Establish the maximum tolerated dose (MTD) of study drug in combination with docetaxel.
Duration of study
Characterize the safety profile of study drug in combination with docetaxel in terms of adverse events, clinical laboratory tests and electrocardiograms.
Duration of study
Characterize the pharmacokinetics (PK) of study drug and docetaxel.
Duration of study
Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine.
Duration of study
Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Duration of study
Characterize the pharmacokinetics (PK) of study drug and capecitabine.
Duration of study
Characterize the safety profile of the new formulation of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Duration of study
Establish the maximum tolerated dose (MTD) of the new formulation of study drug.
Duration of study
Characterize the pharmacokinetics (PK) of the new formulation of study drug (in terms of plasma concentrations) when administered in a fed versus fasted state.
Day 1 and Day 8
Assess the exposure of the new formulation of study drug in terms of plasma concentrations.
Duration of study
Establish the maximum tolerated dose (MTD) of study drug.
Part 1
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Part 1 and Part 2

Secondary Endpoints

Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response.
Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 2
Assess the efficacy of the study drug in combination with docetaxel in terms of tumor response.
Duration of study
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARRY-334543 + gemcitabineEXPERIMENTAL -
ARRY-334543 + docetaxel + prophylactic growth factorsEXPERIMENTAL -
ARRY-334543 + capecitabineEXPERIMENTAL -
ARRY-334543EXPERIMENTAL -

Interventions

NameTypeDescription
ARRY-334543, EGFR/ErbB2 inhibitor; oralDRUGmultiple dose, escalating
Gemcitabine, nucleoside analogue; intravenousDRUGmultiple dose, single schedule
Docetaxel, mitotic inhibitor; intravenousDRUGmultiple dose, single schedule
Prophylactic growth factors; subcutaneousDRUGstandard of care
Capecitabine, 5-fluorouracil prodrug; oralDRUGmultiple dose, single schedule
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria (Part 1): * Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine. * No more than 3 prior anticancer regimens for advanced disease. * Measurable or evaluable, nonmeasurable disease. * Eastern Cooperative Oncology Group (E...

Countries:United StatesCanada
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about ARRY-334543, EGFR/ErbB2 inhibitor

What is ARRY-334543 used for?

ARRY-334543 is an investigational small molecule being studied for the treatment of advanced cancer. It is a targeted therapy that inhibits EGFR and ErbB2, two proteins involved in cancer cell growth. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.

What does ARRY-334543 target?

ARRY-334543 targets EGFR and ErbB2, which are receptor tyrosine kinases involved in cell signaling and tumor growth. By inhibiting these targets, the drug aims to block pathways that drive cancer cell proliferation. This mechanism is being evaluated in patients with advanced cancer.

Who is developing ARRY-334543?

Pfizer, Inc. (NYSE: PFE) is developing ARRY-334543. The company has sponsored multiple Phase 1 clinical trials of the drug in patients with advanced cancer. As of now, the drug remains in early-stage clinical development.

What phase is ARRY-334543 in?

ARRY-334543 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Five Phase 1 trials have been completed, all of which were uncontrolled and non-randomized, with a total enrollment of 203 patients.

What clinical trials has ARRY-334543 been in?

ARRY-334543 has been studied in five completed Phase 1 trials. These include NCT00278902 and NCT00637702, which evaluated the drug alone in advanced cancer, and NCT00710736 and NCT00833326, which tested it in combination with capecitabine and docetaxel, respectively. All trials enrolled adults with advanced cancer.

Is ARRY-334543 the same as EGFR/ErbB2 inhibitor?

Yes, ARRY-334543 is an EGFR/ErbB2 inhibitor. This means it is designed to block the activity of EGFR and ErbB2, two proteins that can promote cancer growth. The drug is being investigated as a potential treatment for advanced cancer, though it remains in early clinical testing.