Recent Updates
Recently added Catalysts

XL184

Phase 3

Thyroid Cancer | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Apr 20, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment330
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00704730Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid CancerPHASE3 COMPLETED 330 — — Jun 1, 2008Sep 1, 2020Apr 20, 2021113 United States, Austria +22
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS)
Treatment period consisted of 4-week cycles with radiologic tumor assessment every 12 weeks from date of randomization until date of first documented PD or date of death from any cause, whichever came first, assessed up to 34 months.

The duration of Progression-Free Survival (PFS) using progression events as determined by Independent Review Committee (IRC) per mRECIST, or death due to any cause. The analysis was conducted after at least 315 subjects were randomized and at least 138 events were observed.

Secondary Endpoints
Overall Survival (OS) With XL184 Compared With Placebo
The pre-specified interim analysis of Overall Survival (OS) was assessed at 44% of required events. Includes data up to 15June2011. As of this date, the number of deaths required to conduct the primary analysis had not been reached.
Objective Response Rate (ORR)
Assessed at the same time as primary analysis of Progression Free Survival (PFS) data. Assessed at baseline and every 12 weeks until Progressive Disease (PD) up to 34 months.
Duration of Objective Response (OR): Independent Radiology Committee (IRC) Determined
From time of first documentation of Objective Response (OR), confirmed at a later visit ≥28 days later as Progressive Disease (PD) as defined by mRECIST or death due to any cause, assessed up to 34 months.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
XL184DRUGGelatin capsules supplied in 25-mg and 100-mg strengths administered orally daily
PlaceboDRUGGelatin capsules color and size-matched to XL184 capsules administered orally daily
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites113

Inclusion Criteria: * The subject has a histologically confirmed diagnosis of MTC that cannot be removed by surgery, is locally advanced, or has spread in the body. * The subject is at least 18 years old. * The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2. * The s...

Countries:United StatesAustriaBelgiumBrazilCanadaChileDenmarkFranceGermanyGreeceIndiaIsraelItalyNetherlandsPeruPolandPortugalRussiaSaudi ArabiaSouth KoreaSpainSwedenSwitzerlandUnited Kingdom
Unlock Eligibility Criteria
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
Unlock Competitive Intelligence