Advanced Solid Tumors Clinical Trial
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
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
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.
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