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dexpantenol

Phase 3

Breast Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Target and mechanism

ModalitySmall molecule

Also known as dexpantenol [Bepantol]

Success Probability

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Market & Valuation

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Trial Design

PLACEBO_CONTROLLED
Total Trials1
Total Enrollment598

FDA Designations

No designations recorded

Clinical trial landscape

dexpantenol · 1 trial · 1 indication

Phase 3 1
NCT00661102A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).Breast Cancer
COMPLETED598 Analytics
PHASE3COMPLETED
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).
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Study Endpoints

Primary Endpoints

Hand-foot syndrome onset
Event driven
QoL C-30 score
Weeks 7, 13 and 17

Secondary Endpoints

Adverse events
Throughout study
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Study Design & Arms

MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
CorticosteroidsDRUGAs prescribed
PlaceboDRUGAs prescribed
capecitabine [Xeloda]DRUGAs prescribed
dexpantenol [Bepantol]DRUGAs prescribed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * adult patients, \>=18 years of age; * breast cancer or colorectal cancer patients; * treated with oral Xeloda for \<=5 days; * lack of hand-foot syndrome (palmar-plantar erythrodysesthesia). Exclusion Criteria: * existence of clinical symptoms suggesting hand-foot syndrome; ...

Countries:Brazil
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Competitive Landscape -Breast Cancer 399 trials

Top 20 of 91 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN46PHASE3Fulvestrant, 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 CorpBCTX1PHASE3SV-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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