At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 21 enrolled
Drug / intervention
Oratecan and Capecitabinedrug
Likely dose
Oratecan and Capecitabine 10 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer
In Brief
A Phase 1 clinical trial evaluating Oratecan and Capecitabine for Solid Tumor and Advanced Cancer. Completed, enrolled 21 participants across 1 site.
Detailed Summary
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Advanced Cancer
CountriesSouth Korea
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedNov 2011
Primary CompletionApr 2012
Study CompletionDec 2013
TodayJul 2026
First PostedNov 2, 2011
Enrollment StartDec 1, 2010
Primary CompletionApr 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.7 years ago
Interventions
Oratecan and Capecitabinedrug
Oratecan in combination with Capecitabine * Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1\~Day5 * HM30181AK Tablet - Fixed dose 15 mg, Day1\~Day5 * Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1\~Day14