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Cavilon Durable Barrier

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment333

FDA Designations

No designations recorded

Clinical trial landscape

Cavilon Durable Barrier · 1 trial · 1 indication

Phase 3 1
NCT00193908Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") CreamBreast Cancer
COMPLETED333 Analytics
PHASE3COMPLETED
Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine ("Sorbolene") Cream
Breast CancerUnlock trial analytics

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 to 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 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about Cavilon Durable Barrier

What is Cavilon Durable Barrier used for in breast cancer?

Cavilon Durable Barrier is a small molecule being studied for use in breast cancer patients. It is a barrier cream that was evaluated in a Phase 3 clinical trial for its effects compared to a glycerine cream. The investigational product is intended for topical application, though the specific clinical use in breast cancer is not detailed.

Who makes Cavilon Durable Barrier?

Cavilon Durable Barrier is developed by 3M Company, which trades under the ticker MMM. The company conducted a Phase 3 clinical trial of the product in breast cancer patients. 3M is the sole developer of this investigational barrier cream.

What phase is Cavilon Durable Barrier in?

Cavilon Durable Barrier is in Phase 3 clinical development. The Phase 3 trial, NCT00193908, has been completed. The product is investigational and has not been approved by regulatory authorities. It remains in clinical development for its potential use in breast cancer.

What clinical trials is Cavilon Durable Barrier in?

Cavilon Durable Barrier has one completed Phase 3 clinical trial, NCT00193908, titled "Cavilon Breast Trial: Comparison of Cavilon Durable Barrier Cream to Glycerine (\"Sorbolene\") Cream." The trial enrolled 333 participants with breast cancer in Australia and was randomized, double-blind, and controlled.

What does Cavilon Durable Barrier target?

Cavilon Durable Barrier does not have a specified molecular target or target class. It is a barrier cream, and its mechanism of action is not described in the available data. The product is being studied for its effects in breast cancer patients, but no specific biological target has been identified.

Is Cavilon Durable Barrier the same as Sorbolene cream?

Cavilon Durable Barrier is not the same as Sorbolene cream. In the Phase 3 clinical trial NCT00193908, Cavilon Durable Barrier was compared to glycerine cream, also known as Sorbolene. The trial was designed to evaluate the barrier cream against this comparator, indicating they are distinct products.