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This is a multicenter, open-label, safety study. Eligible subjects will be adults with advanced malignancies. The study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline periods. The treatment phase consists of 4-week treatment periods and a follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORAXOL | Experimental | Oraxol (paclitaxel + HM30181AK-US) Oraxol paclitaxel - supplied as 30-mg capsules Oraxol HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oraxol | Drug | Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) of Oraxol | The highest dose at which no more than 1 of 6 subjects experience a dose-limiting toxicity (DLT) during treatment | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate tumor response | RECIST v1.1 criteria defined as complete response, partial response, stable disease or progressive disease | At baseline and every 8 weeks through study completion, approximately 24 months |
| Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E D Kramer, MD | Kinex Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Roswell Park Cancer Institute |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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Number of Participants with abnormal laboratory values and/or adverse events that are related to treatment |
| 4 weeks |
| The amount of Oraxol in the blood stream | The measurement of Oraxol levels in the blood stream over time | 3 weeks |
| The recommended Phase 2 dose of paclitaxel as Oraxol | The totality of information from the number of participants that reach the MTD (outcome #1), the number of participants that experience abnormal laboratory values and/or adverse events that are related to treatment (outcome #3), and the amount of Oraxol in the blood stream in participants (outcome #4) | 24 months |
| Buffalo |
| New York |
| 14263 |
| United States |
| Cancer Therapy &Research Center @ UTHSCSA | San Antonio | Texas | 78229 | United States |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |