NCT01455571

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

Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (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.

Detailed description

Besides the main objective, there are 3 other objectives as follows: 1. To determine dose-limiting toxicity (DLT) of HM781-36B 2. To characterize the pharmacokinetics of HM781-36B, following oral administration of HM781-36B 3. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies Groups of 3 patients per cohort or dose level will be treated with escalating doses of HM781-36B

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	HM781-36B	Q1DX14/2W for 3W HM781-36B

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-10-20
• Last updated: 2014-02-26

Locations

1 site across 1 country: South Korea