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Thyrogen

Phase 3

Differentiated Thyroid Cancer | Small molecule | Oncology |Sanofi|Last Updated: Mar 18, 2015

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 Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00295763A New Study to Follow-up Thyroid Cancer Patients Who Participated in a Previous Study, Which Compared the Success of Destruction of the Thyroid Remnant Using Standard Treatment or Thyrogen.PHASE3 COMPLETED 61May 1, 2006Sep 1, 2006Mar 18, 20159 United States, Canada +3
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Study Endpoints
Primary Endpoints
To confirm the status of thyroid remnant ablation by using Thyrogen stimulated radioiodine whole body scans (WBS) in patients previously treated in THYR-008-00.
Duration of study
To learn if there was recurrence of thyroid cancer in any of the patients previously treated in the THYR-008-00 study.
Duration of study
To assess Thyrogen-stimulated serum Tg measurements in patients previously treated in the THYR-008-00 study.
Duration of study
To assess safety information on repeat exposure to Thyrogen in patients previously treated in the THYR-008-00 study.
Duration of study
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1OTHER -
Interventions
NameTypeDescription
Thyrogen (thyrotropin alfa for injection)DRUGNo reference therapy was given. All patients in this follow-up study received Thyrogen. Thyrogen 0.9 mg was administered intramuscularly (IM) in the buttock on 2 consecutive days. For WBS and static neck imaging, each patient received 4 mCi (148 MBq) ± 0.4 mCi 131I PO.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Committed to follow the protocol requirements, as evidenced by providing written informed consent before any study-related procedures are performed and within 28 days prior to Day 1; * Completed the THYR-008-00 study; * A negative serum pregnancy test within 8 days prior to th...

Countries:United StatesCanadaFranceGermanyItaly
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