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Capecitabine orally days 1-21

Phase 1

Pancreatic Cancer | Small molecule | Oncology |Roche Holding AG|Trials Updated: Oct 14, 2016

Capecitabine orally days 1-21 target and mechanism

Molecular targetTYMS
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment44

FDA Designations

No designations recorded

Capecitabine orally days 1-21 clinical trials

Capecitabine orally days 1-21 · 1 trial · 1 indication

Phase 1 1
NCT00260364Combining Erlotinib Plus Bevacizumab and Gemcitabine Plus Capecitabine to Treat Advanced Pancreatic CancerPancreatic Cancer
COMPLETED44 Analytics
PHASE1COMPLETED
Combining Erlotinib Plus Bevacizumab and Gemcitabine Plus Capecitabine to Treat Advanced Pancreatic Cancer
Pancreatic CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A (Phase I): Dose-limiting Toxicity (DLT)
Part B (Phase II): Overall response rate (complete response and partial response)

Secondary Endpoints

The secondary efficacy objectives of the trial are: One year survival and median overall survival
Progression free survival, Disease control rate.
The secondary safety objectives are: Toxicity,Quality of life
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Gemcitabine 1000 mg/m2 iv days 1, 8, 15 of a 28 day cycleDRUG -
Capecitabine orally days 1 -21DRUG -
Erlotinib 100 mg orally days 1-28DRUG -
Bevacizumab 5 mg/kg intravenously every 2 weeksDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Locally advanced or metastatic disease * Not amenable to curative resection * No invasion of adjacent organs (e.g., duodenum or stomach) by CT scan * Unidimensionally measurable disease as assessed...

Countries:United Kingdom
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Competitive Landscape -Pancreatic Cancer 248 trials

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