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ARRY-334543, EGFR/ErbB2 inhibitor

Phase 1/2

Advanced Cancer | Small Molecules | Oncology |Pfizer, Inc.|Trials Updated: Oct 14, 2020

Success Probability

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Trial Design

UNCONTROLLEDBiomarker
Total Trials5
Total Enrollment203

FDA Designations

No designations recorded

ARRY-334543, EGFR/ErbB2 inhibitor clinical trials

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

Phase 1/2 1Phase 1 4
NCT00862524A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic CancerAdvanced Cancer
COMPLETED20 Analytics
PHASE1/PHASE2COMPLETED
A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic 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 14 trials (matched to "Advanced Cancer")

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

What is ARRY-334543?

ARRY-334543 is an oral small molecule drug being developed by Pfizer for the treatment of advanced cancer. It is an EGFR/ErbB2 inhibitor that has been studied in Phase 1 clinical trials, both as a single agent and in combination with chemotherapy agents, in patients with advanced solid tumors.

What does ARRY-334543 target?

ARRY-334543 targets EGFR and ErbB2, also known as HER2. It is an EGFR/ErbB2 inhibitor, meaning it is designed to block signaling through these two receptor tyrosine kinases. The trials for ARRY-334543 were biomarker-selected, enrolling patients based on relevant molecular characteristics.

Who is developing ARRY-334543?

Pfizer, Inc. is the developer of ARRY-334543. Pfizer trades on the New York Stock Exchange under the ticker PFE. The drug is an oral small molecule EGFR/ErbB2 inhibitor being evaluated in oncology.

What phase is ARRY-334543 in?

ARRY-334543 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All five of its recorded trials are Phase 1 studies, and all five are listed as completed, with no active trials currently reported.

What clinical trials is ARRY-334543 in?

Five Phase 1 trials of ARRY-334543 have been conducted, all completed. These include NCT00862524 with gemcitabine in advanced cancer and pancreatic cancer, NCT00833326 with docetaxel, NCT00710736 with capecitabine, and NCT00637702 as a single agent. Total enrollment across the trials was 203 patients.

Is ARRY-334543 the same as ARRY-334543 oral?

Yes. ARRY-334543 and ARRY-334543 oral refer to the same drug. ARRY-334543 is an orally administered small molecule EGFR/ErbB2 inhibitor developed by Pfizer for advanced cancer, so the oral designation describes its route of administration rather than a separate product.