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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel +HM30181 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel+HM30181 | Drug | oral, 3times for 4weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD determination | Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2015 | |
| Reset | Jun 1, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2015 | Jun 1, 2015 |