NCT01455584

Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors

Phase Ⅰ Study to Determine the Maximum Tolerated Dose of HM781-36B Continuously Given in Patients With Advanced Solid Tumors and to Assess the Food Effect on Pharmacokinetic Profile

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (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 HM781-36B continuously.

Detailed description

Besides the main objective, there are 4 other objectives as follows: 1. To determine dose-limiting toxicity (DLT) of HM781-36B 2. To determine Maximum Tolerated Dose (MTD) of HM781-36B 3. To determine the effect of food on the pharmacokinetics after dosed HM781-36B continuously 4. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	HM781-36B tablets	Q1X28D/4W for HM781-36B tablets

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-10-20
• Last updated: 2013-05-23

Locations

1 site across 1 country: South Korea