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Cabozantinib S-

Phase 2

Poorly Differentiated Thyroid Gland Carcinoma | Small molecule | Oncology |Exelixis, Inc.|Last Updated: Apr 3, 2018

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01811212Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid CancerPHASE2 COMPLETED 25 — — May 8, 2013Oct 9, 2017Apr 3, 20187 United States
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Study Endpoints
Primary Endpoints
Objective Response Rate, Defined as the Proportion of Patients Who Have Had a PR or CR as Assessed by the RECIST Version (v)1.1
Up to 6 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary Endpoints
Bone Turnover, as Measured by Serum and Urinary Markers of Bone Turnover
Up to 2 months
Duration of Objective Response as Assessed by the RECIST v1.1
From date of documentation of response to the date of progression or death, assessed up to 1 year
Expression Levels of Predictive Biomarkers of Response by Immunohistochemistry in Archived Tumor Tissue
Baseline
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment (cabozantinib-s-malate)EXPERIMENTALPatients receive cabozantinib-s-malate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
NameTypeDescription
Cabozantinib S-malateDRUGGiven PO
Laboratory Biomarker AnalysisOTHERCorrelative studies
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Patients must have histologically or cytologically confirmed papillary thyroid cancer, follicular thyroid cancer or hurthle cell thyroid cancer (cancer, follicular variant of papillary thyroid cancers or any of the above mixed histology will be allowed; these patients will be ...

Countries:United States
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