Trials / Completed
CompletedNCT00940758
Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy
Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- PharmaEngine · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the dose-limiting toxicity (DLT), toxicity profile, maximum tolerated dose (MTD) and characterize the pharmacokinetics of biweekly PEP02 treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEP02 | Dose escalation: 50-100 mg/m2 biweekly |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2012-05-01
- Completion
- 2014-06-01
- First posted
- 2009-07-16
- Last updated
- 2017-04-06
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT00940758. Inclusion in this directory is not an endorsement.