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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials5
Total Enrollment203
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00862524A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic CancerPHASE1 COMPLETED 20 — — Mar 1, 2009Feb 1, 2011Oct 4, 20126 United States
NCT00833326A Study of ARRY-334543 and Docetaxel in Patients With Advanced CancerPHASE1 COMPLETED 27 — — Jan 1, 2009Jul 1, 2010Oct 6, 20203 United States
NCT00710736A Study of ARRY-334543 and Capecitabine in Patients With Advanced CancerPHASE1 COMPLETED 29 — — Jun 1, 2008Apr 1, 2011Oct 6, 20204 United States, Canada
NCT00637702A Study of ARRY-334543 in Patients With Advanced CancerPHASE1 COMPLETED 31 — — Feb 1, 2008Oct 1, 2012Oct 8, 20202 Canada
NCT00278902A Study of ARRY-334543 in Patients With Advanced CancerPHASE1 COMPLETED 96 — — Jan 1, 2006Jun 1, 2009Oct 14, 20205 United States, Canada
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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 — 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
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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