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Cavilon Durable Barrier

Phase 3

Breast Cancer | Small molecule | Oncology |3M Company|Last Updated: May 14, 2009

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-BlindCONTROLLED
Total Trials1
Total Enrollment333
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00193908Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") CreamPHASE3 COMPLETED 333Mar 1, 2004Oct 1, 2008May 14, 200912 Australia
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Study Endpoints
Primary Endpoints
Frequency of moist desquamation (grade 3) acute skin reaction scored as worst reaction within allocated skin care area
12 weeks
Secondary Endpoints
Skin toxicity area under the curve (AUC) being sum of maximum skin reaction per week over 12 weeks
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
Interventions
NameTypeDescription
Cavilon (TM) Durable Barrier CreamDRUGCavilon (TM) Durable Barrier Cream will be applied to either the medial or the lateral side of the treated breast. Side will depend on randomisation.
SorboleneDRUGSorbolene will be applied to either the medial or the lateral side of the treated breast. Side will be determined by randomisation
RadiotherapyRADIATIONMinimum prescribed dose to the chest wall is 45Gy in 25 fractions. Planning and Treatment is per the study protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Ages 18 or more years * Post total mastectomy * Planned dose at least 45 Gy in 25 fractions * ECOG 0-2 * Able to attend weekly during treatment for review and photo and for up to 6 weeks after radiotherapy * Patients capable of childbearing using adequate contraception * Writt...

Countries:Australia
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Competitive Landscape -Breast Cancer 408 trials
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