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capecitabine RTD

Phase 1

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

capecitabine RTD development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2011

capecitabine RTD target and mechanism

Molecular targetTYMS
Target classInhibitor
ModalitySmall molecule

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

capecitabine RTD clinical trials

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 CancerUnlock trial analytics

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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Frequently asked questions about capecitabine RTD

What is capecitabine RTD?

Capecitabine RTD is a rapid disintegrating tablet formulation of capecitabine developed by Roche Holding AG. It is an investigational small molecule being studied in breast cancer and colorectal cancer. The rapid disintegrating tablet is designed as an alternative oral form of capecitabine, which is also marketed as Xeloda.

What is capecitabine RTD used for?

Capecitabine RTD is being studied for the treatment of breast cancer and colorectal cancer. It is an oral small molecule formulation of capecitabine, and its development focuses on these two solid tumor types. It remains investigational and is not established as an approved treatment in this rapid disintegrating tablet form.

What does capecitabine RTD target?

Capecitabine RTD targets thymidylate synthase, also known as TYMS. It acts as an inhibitor of this enzyme. Thymidylate synthase is involved in DNA synthesis, and inhibiting it interferes with the ability of cancer cells to replicate, which is the basis for its use in breast and colorectal cancer research.

Who makes capecitabine RTD?

Capecitabine RTD is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the company behind the rapid disintegrating tablet formulation of capecitabine studied in solid tumors. The same company markets the commercial capecitabine product Xeloda.

What phase is capecitabine RTD in?

Capecitabine RTD is in Phase 1 clinical development. It is an investigational formulation and has not been established as an approved product in this rapid disintegrating tablet form. The Phase 1 program has been completed, with no active trials currently listed for this formulation.

What clinical trials is capecitabine RTD in?

Capecitabine RTD was studied in one completed Phase 1 trial, NCT01493336, titled a study of capecitabine rapid disintegrating tablets versus commercial Xeloda in patients with solid tumours. That trial enrolled 37 participants across Australia, New Zealand, and the United Kingdom, and it was randomized and active controlled.