Trials / Unknown
UnknownNCT01491217
A Study of Oraxol® in Gastric Cancer Patients
A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 53 (estimated)
- Sponsor
- Hanmi Pharmaceutical Company Limited · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel | HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2012-03-01
- Completion
- 2012-12-01
- First posted
- 2011-12-13
- Last updated
- 2011-12-13
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01491217. Inclusion in this directory is not an endorsement.