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The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.
Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity evaluation (safety evaluation) | Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0). | DLT will be assessed on 28days of 1 cycle |
| Overall response rate(ORR) evaluation | It is measured up to confirmation of tumor response(CR, PR) Tumor response will be evaluated by RECIST v1.0. | Response will be evaluated every Cycle 2(8weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung-Mi Park, Ph.D | Contact | kmpark@hanmi.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Yung-Jue Bang, MD. Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Goyang | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26112004 | Derived | Lee KW, Lee KH, Zang DY, Park YI, Shin DB, Kim JW, Im SA, Koh SA, Yu KS, Cho JY, Jung JA, Bang YJ. Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer. Oncologist. 2015 Aug;20(8):896-7. doi: 10.1634/theoncologist.2015-0202. Epub 2015 Jun 25. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2015 | |
| Reset | Jun 5, 2015 | |
| Release | May 18, 2020 | |
| Reset | Jun 1, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2015 | Jun 5, 2015 | |||
| May 18, 2020 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Jun 1, 2020 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |