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capecitabine RTD

Phase 1

Breast Cancer, Colorectal 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

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

capecitabine RTD · 1 trial · 1 indication

Phase 1 1
NCT01493336A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid TumoursBreast Cancer, Colorectal Cancer
COMPLETED37 Analytics
PHASE1COMPLETED
A Study of Capecitabine Rapid Disintegrating Tablets (RDT) Versus Commercial Xeloda in Patients With Solid Tumours
Breast Cancer, Colorectal Cancer
NCT0149333637
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Study Endpoints

Primary Endpoints

Relative bioavailability: Area under the concentration-time curve (AUC)
Multiple sampling pre-dose to 6 hours post-dose

Secondary Endpoints

Safety: Incidence of adverse events
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Capecitabine RTDEXPERIMENTAL -
XelodaACTIVE_COMPARATOR -

Interventions

NameTypeDescription
capecitabine RTDDRUGsingle oral dose
capecitabine [Xeloda]DRUGsingle oral dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Adult patients,\>/= 18 years of age * Histological/cytological confirmation of colorectal or breast cancer * Patient is ambulatory and has a Karnofsky performance status of \> 70% * Body surface area between 1.5 and 2.0 m2 * Either: * Due to receive Xeloda as monotherapy or as...

Countries:AustraliaNew ZealandUnited Kingdom
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