NCT01463982

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Besides the main objective, there are 4 other objectives as follows: * To assess the safety of Oratecan in combination with capecitabine * To evaluate anticancer activity of Oratecan in combination with capecitabine in patients with advanced solid malignancies * To characterize the pharmacokinetics of Oratecan and its metabolites following oral administration of OratecanTM in combination with capecitabine

Conditions

• Solid Tumor
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Oratecan and Capecitabine	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

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-04-01
• Completion: 2013-12-01
• First posted: 2011-11-02
• Last updated: 2015-04-23
• Results posted: 2015-04-23

Locations

1 site across 1 country: South Korea