drugset / Trial / NCT00979563

Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies

NCT00979563

Phase 1 Completed 15 enrolled Hanmi Pharmaceutical Company Limited
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The main objective of this study is to determine the maximum tolerated dose (MTD) of OratecanTM. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy or for which no established therapy exists at the time of study participation.

Timeline

Start
2008-07
Primary completion
2010-03
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject HM30181AK Unknown 60 mg Oral
Subject Irinotecan Small molecule 2 mg Oral
Subject Irinotecan Small molecule 5 mg Oral
Subject Irinotecan Small molecule 20 mg Oral