drugset / Trial / NCT01463982

Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies

NCT01463982

Phase 1 Completed 21 enrolled Hanmi Pharmaceutical Company Limited
NaSingle-groupOpen-labelTreatment

Summary

The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine

Timeline

Start
2010-12
Primary completion
2012-04
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 800 mg/m2
Subject Capecitabine Small molecule 1000 mg/m2
Subject HM30181AK Unknown 15 mg Oral
Subject Irinotecan Small molecule 10 mg/m2 Oral
Subject Irinotecan Small molecule 20 mg/m2 Oral

Indications