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ZD-1839

Phase 2

Head and Neck Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 27, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00242762ZD1839 (IRESSA™) in Combination With Docetaxel & Cisplatin in Subjects With Metastatic Head & Neck CancerPHASE2 COMPLETED 36 — — Jul 1, 2003Mar 1, 2006Jan 27, 20114 Spain
NCT00185835Cisplatin and ZD1839 + Re-Irradiation in Recurrent Squamous Cell Cancer of the Head and NeckPHASE1 COMPLETED 10 — — Jun 1, 2002 -Mar 29, 20101 United States
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Study Endpoints
Primary Endpoints
Objective tumour response (CR and PR) at study closure based on the Response Evaluation Criteria in Solid Tumours (RECIST)
To determine safety profile of the epidermal growth factor receptor (EGFR) antagonist, ZD 1839 in combination with cisplatin and radiation therapy in patients with local-regional recurrent squamous cell cancer of the head and neck
no known
Secondary Endpoints
PFS
Overall survival
Incidence of DLT during the first cycle of study treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ZD1839 (IRESSA™)DRUG -
DocetaxelDRUG -
CisplatinDRUG -
ZD-1839DRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Male or female, aged 18 and 70 years, inclusive 2. Histologically- or cytologically-confirmed recurrent and/or metastatic SCCHN 3. Primary tumour site of oral cavity, oropharynx, hypopharynx or larynx 4. At least one uni-dimensionally measurable lesion according to the RECIST...

Countries:SpainUnited States
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Competitive Landscape -Head and Neck Cancer 156 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN9PHASE3Monalizumab, Cetuximab, volrustomig, Volrustomig, Cisplatin
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Remzistotug, Niraparib
Merck & Co., Inc.MRK3PHASE3Pembrolizumab, Cisplatin /m^2, pembrolizumab, Cisplatin, Docetaxel
Johnson & JohnsonJNJ4PHASE3JNJ-90301900, Cetuximab, Amivantamab, Pembrolizumab, Carboplatin
Pfizer Inc.PFE6PHASE2tisotumab vedotin, pembrolizumab, carboplatin, cisplatin, Palbociclib
Regeneron Pharmaceuticals, Inc.REGN4PHASE2cemiplimab, Platinum Doublet, fianlimab, fianlimab+cemiplimab, Cemiplimab
PDS Biotechnology Corp.PDSB1PHASE3Combination Treatment of PDS0101 and Pembrolizumab, Pembrolizumab Monotherapy
Exelixis, Inc.EXEL4PHASE2Zanzalintinib, Pembrolizumab, cabozantinib, atezolizumab, Nivolumab
Merus B.V.MRUS4PHASE3Petosemtamab, Pembrolizumab, MCLA-129, Osimertinib, Chemotherapy
Bristol-Myers Squibb CompanyBMY3PHASE2Nivolumab, Relatlimab, Ipilimumab, Intratumoral Ipilimumab, BMS-986340
Bicara Therapeutics Inc.BCAX3PHASE2Ficerafusp alfa, Nivolumab, Pembrolizumab, BCA101
Gilead Sciences, Inc.GILD2PHASE2Domvanalimab, Zimberelimab, Paclitaxel, Carboplatin
Inhibrx Biosciences, Inc.INBX2PHASE2INBRX-106, Pembrolizumab, INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5
Incyte CorporationINCY1PHASE2Retifanlimab, INCAGN02385, INCAGN02390
BioNTech SE Sponsored ADRBNTX1PHASE2BNT113, Pembrolizumab
Coherus Oncology, Inc.CHRS4PHASE2Toripalimab, Carboplatin, Cisplatin, Paclitaxel, Docetaxel
ALX Oncology Holdings, Inc.ALXO3PHASE2evorpacept, pembrolizumab, Cisplatin/Carboplatin; 5FU, ALX2004
ImmunityBio IncIBRX2PHASE2N-803 + Pembrolizumab, PD-L1 t-haNK, Cetuximab, NAI
Summit Therapeutics IncSMMT2PHASE3Ivonescimab /kg, Ligufalimab, Pembrolizumab, Ivonescimab
IO Biotech, Inc.IOBT1PHASE2IO102-IO103, Pembrolizumab KEYTRUDA
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