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ZD6474

Phase 3

Thyroid Cancer | Small molecule | Oncology |Sanofi|Last Updated: Sep 24, 2025

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
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDBiomarker
Total Trials3
Total Enrollment390
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00410761An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid CancerPHASE3 COMPLETED 331 — — Nov 23, 2006Jul 26, 2024Sep 24, 2025127 United States, Australia +22
NCT00358956A Study To Assess ZD6474 (ZACTIMA™) Monotherapy In Locally Advanced or Metastatic Hereditary Medullary Thyroid CancerPHASE2 COMPLETED 19 — — Aug 1, 2006May 1, 2014Jan 30, 20179 United States, Australia +6
NCT00098345Efficacy and Tolerability of ZD6474 in Patients With Thyroid CancerPHASE2 COMPLETED 40 — — Nov 1, 2004Apr 19, 2017May 7, 20186 United States, France
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Study Endpoints
Primary Endpoints
Progression-Free Survival(PFS)
RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent.

Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.

Objective Response Rate (ORR)
RECIST assessed at screening (up to 3 weeks prior to first dose), then every 12 weeks (± 2 weeks), from date of first dose to objective progression, up to and including discontinuation of study treatment.

The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 12 weeks, progressive disease (PD) or NE.

Objective Response Rate
Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.

The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.

Secondary Endpoints
Objective Response Rate (ORR)
RECIST assessments performed at screening (within 3 weeks before randomisation), then every 12 weeks. For patients with objective response of CR or PR, an additional confirmatory scan was performed ≥4 weeks following the date of first response.
Disease Control Rate (DCR)
RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent
Duration of Response (DoR)
RECIST tumour assessments were performed at screening (within 3 weeks before date of randomisation), then once every 12 weeks up to and including discontinuation of blinded study treatment, unless patients had withdrawn consent
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1NO_INTERVENTIONPlacebo vandetanib
2EXPERIMENTALVandetanib
Caprelsa (vandetanib) 300 mgEXPERIMENTALDaily oral dose of Caprelsa (vandetanib) 300mg
Interventions
NameTypeDescription
ZD6474 (Vandetanib)DRUGonce daily oral tablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites127

Inclusion Criteria: * Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer. * Presence of measurable tumor * Able to swallow medication Exclusion Criteria: * Major surgery within 4 weeks before randomization * Last dose of prior chemo...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaCzechiaDenmarkFranceGermanyHungaryIndiaItalyMexicoNetherlandsPolandPortugalRomaniaRussiaSerbiaSouth KoreaSpainSwedenSwitzerland
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Competitive Landscape -Thyroid Cancer 36 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY5PHASE3Selpercatinib, Cabozantinib, Vandetanib, LOXO-260, LOXO-292
Novartis AG Sponsored ADRNVS2PHASE3Dabrafenib, Trametinib, KFA115, pembrolizumab
Exelixis, Inc.EXEL2PHASE3Cabozantinib, cabozantinib, atezolizumab
Merck & Co., Inc.MRK1PHASE2pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Pfizer Inc.PFE2PHASE1PF-07799933, binimetinib, cetuximab, midazolam, fluorouracil
Sensei Biotherapeutics, Inc.SNSE1PHASE1SNS-101, Cemiplimab
Novo Nordisk A/S Sponsored ADR Class BNVO1 — Undisclosed
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
OPKO Health, Inc.OPK1PHASE1MDX2001
Precision BioSciences, Inc.DTIL1PHASE1CD70-targeted CAR-T cells
Tango Therapeutics, Inc.TNGX1PHASE1S241656, FOLFOX6/FOLFOX7, FOLFIRI, Cetuximab, Panitumumab
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