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dexpantenol

Phase 3

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

dexpantenol 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

dexpantenol clinical trials

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).
Breast CancerUnlock trial analytics

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 611 trials

Frequently asked questions about dexpantenol

What is dexpantenol used for in breast cancer?

Dexpantenol was studied as a prophylactic treatment for hand-foot syndrome in breast cancer patients receiving oral Xeloda (capecitabine). Hand-foot syndrome is a common side effect of capecitabine therapy. The Phase 3 trial evaluated whether dexpantenol could prevent this skin reaction in patients undergoing treatment for breast cancer.

Who makes dexpantenol?

Dexpantenol is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche conducted the Phase 3 clinical trial of dexpantenol for hand-foot syndrome prophylaxis in breast cancer patients treated with capecitabine.

What phase is dexpantenol in?

Dexpantenol is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently ongoing. The completed trial enrolled 598 patients and evaluated dexpantenol for the prevention of hand-foot syndrome in breast cancer patients receiving oral Xeloda (capecitabine).

What clinical trials is dexpantenol in?

Dexpantenol has been studied in one completed Phase 3 clinical trial, NCT00661102, titled "A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine)." The trial enrolled 598 patients with breast cancer in Brazil and was placebo-controlled.

Is dexpantenol the same as Bepantol?

Yes, dexpantenol is also known as dexpantenol [Bepantol]. Bepantol is a brand name under which dexpantenol is marketed. In the context of the Phase 3 trial, dexpantenol was investigated for preventing hand-foot syndrome in breast cancer patients treated with capecitabine.