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
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
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|Experimental: paclitaxel +HM30181||
oral, 3times for 4weeks
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.