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Irinotecan-Capecitabine-Oxaliplatin

Phase 2

Gastrointestinal Neoplasm | Small Molecules | Oncology |Sanofi|Trials Updated: Feb 25, 2019

Irinotecan-Capecitabine-Oxaliplatin development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since May 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Irinotecan-Capecitabine-Oxaliplatin clinical trials

Irinotecan-Capecitabine-Oxaliplatin · 1 trial · 2 indications

Phase 2 1
NCT01129310First Line Study of Irinotecan, Capecitabine and Oxaliplatin in Metastatic Gastric or Gastroesophageal Cancer.Gastrointestinal Neoplasm
COMPLETED47 Analytics
PHASE2COMPLETED
First Line Study of Irinotecan, Capecitabine and Oxaliplatin in Metastatic Gastric or Gastroesophageal Cancer.
Gastrointestinal Neoplasm
NCT0112931047
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Study Endpoints

Primary Endpoints

Overall Response Rate and dose limiting toxicity
2 years

Secondary Endpoints

Progression Free Survival, overall survival, death, alterations in quality of life outcomes
2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Irinotecan-Capecitabine-OxaliplatinDRUGIrinotecan-160mg/m2 IV infusion over 60-90 min on Day 1 Capecitabine-1900mg/m2 daily PO in divided doses (=950mg/m2 BID) on days 2-15 Oxaliplatin- 100mg/m2 IV infusion over 2 hours Day 1
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Eligibility Criteria

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

Inclusion Criteria: * histologically documented gastric GEJ adenocarcinoma not previously treated with palliative systemic therapy. * Metastatic disease based on the presence of clinically and/or radiologically documented measurable disease based on RECIST. * ECOG performance status of 0,1 or 2. * ...

Countries:Canada
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