Trials / Completed
CompletedNCT00882973
Trial to Determine the Maximum Tolerated Dose of Genexol-PM Plus Gemcitabine and Evaluate Efficacy and Safety of Genexol-PM Regimens in Subjects With Advanced Pancreatic Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Samyang Biopharmaceuticals Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase I/II trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol-PM and gemcitabine (hereafter Genexol-PM plus gemcitabine) and to evaluate the efficacy and safety of Genexol-PM regimens (monotherapy and combination with gemcitabine) and gemcitabine monotherapy in subjects with locally advanced or metastatic pancreatic cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Genexol-PM | Cremophor EL-free polymeric micelle of paclitaxel |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2009-08-01
- Completion
- 2010-11-01
- First posted
- 2009-04-17
- Last updated
- 2017-05-05
Source: ClinicalTrials.gov record NCT00882973. Inclusion in this directory is not an endorsement.