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Corticosteroids

Phase 3

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

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

Corticosteroids · 3 trials · 3 indications

Phase 3 2Phase 2 1
NCT00661102A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).Breast Cancer
COMPLETED598 Analytics
NCT00048152A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant PatientsKidney Transplantation
COMPLETED539 Analytics
PHASE3COMPLETED
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).
Breast CancerUnlock trial analytics
PHASE3COMPLETED
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients
Kidney TransplantationUnlock trial analytics

Study Endpoints

Primary Endpoints

Hand-foot syndrome onset
Event driven
QoL C-30 score
Weeks 7, 13 and 17
Renal function (as measured by GFR)
12 months post-transplant
Proportion of patients with an ACR20 response
24 weeks

Secondary Endpoints

Adverse events
Throughout study
Patient and graft survival \n
12 months post-transplant
Proportion of patients with biopsy-proven rejection; treatment failure.
6 and 12 months post-transplant
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Study Design & Arms

MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
3PLACEBO_COMPARATOR -
4EXPERIMENTAL -
5EXPERIMENTAL -
6EXPERIMENTAL -
7PLACEBO_COMPARATOR -
8PLACEBO_COMPARATOR -
9PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
CorticosteroidsDRUGAs prescribed
PlaceboDRUGAs prescribed
capecitabine [Xeloda]DRUGAs prescribed
dexpantenol [Bepantol]DRUGAs prescribed
NeoralDRUGLow dose (target trough level 50-100ng/mL)
ZenapaxDRUG2mg/kg iv first dose, then 1mg/kg every 2 weeks
mycophenolate mofetil [CellCept]DRUG1g po bid
methotrexateDRUGOral or parenteral repeating dose
rituximabDRUGIntravenous repeating dose
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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:BrazilUnited StatesAustraliaBelgiumCanadaFranceGermanyMexicoNorwayPolandSpainSwedenUnited Kingdom
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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 Corticosteroids

What is Corticosteroids used for?

Corticosteroids are used for breast cancer, rheumatoid arthritis, and kidney transplantation. They are being studied in clinical trials for these conditions, including as a prophylactic treatment for hand-foot syndrome in breast cancer patients treated with capecitabine.

Who makes Corticosteroids?

Corticosteroids are being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's efficacy and safety in various indications.

What phase is Corticosteroids in?

Corticosteroids are in Phase 3 clinical development. They are investigational and have not been approved by regulatory authorities. The drug is being studied for multiple indications, including breast cancer and kidney transplantation.

What clinical trials is Corticosteroids in?

Corticosteroids are being studied in clinical trials including NCT00048152 for kidney transplantation, NCT00074438 for rheumatoid arthritis, and NCT00661102 for breast cancer. These trials have been completed and enrolled a total of 598 participants.

Is Corticosteroids the same as Zenapax or CellCept?

Corticosteroids are not the same as Zenapax (daclizumab) or CellCept (mycophenolate mofetil). In one trial, NCT00048152, corticosteroids were used in combination with these drugs to assess kidney function in transplant patients.