NCT01491204

Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of Oral Paclitaxel in Patients With Advanced Solid Cancer

Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of Oral Paclitaxel in Patients With Advanced Solid Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to determine the maximum tolerated dose (MTD) of Oral Paclitaxel. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy. Administration Schedule: 1 cycle of Oraxol®(paclitaxel+HM30181A) medication was 28 days and Oraxol® was administrated total 3 times once a week (day 1, 8, 15). The next cycle started on day 29. Methods of Administration: HM30181A tablet was administered 1hour prior to the medication of paclitaxel

Detailed description

Besides the main objective, there are 3 other objectives as follows. To determine dose-limiting toxicity (DLT) Of Oraxol. To characterize the pharmacokinetics of HM30181A(pgp inhibitor), paclitaxel and its metabolites following oral administration of Oraxol. To evaluate anticancer activity of Oraxol.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Paclitaxel+HM30181	oral, 3times for 4weeks

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2011-12-13
• Last updated: 2011-12-13