Status:
COMPLETED
Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy
Lead Sponsor:
PharmaEngine
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Histopathologically confirmed metastatic colorectal cancer
- Documented disease progression after first-line chemotherapy containing oxaliplatin
- Both genders, age 18 years
- ECOG performance status 0 or 1
- Adequate organ and marrow function
- Written informed consent to participate in the study
Exclusion
- Have received irinotecan treatment
- With active CNS metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- With clinically significant gastrointestinal disorder (e.g. bleeding, inflammation, obstruction, including partial or complete obstruction secondary to peritoneal carcinomatosis, or diarrhea \> grade 1)
- With uncontrolled intercurrent illness that could limit study compliance considered to be ineligible for the study by the investigators including, but NOT limited to, any of the following:ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
- With other primary malignancies, except those remain disease-free for 3 or more years after curative treatment.
- Prior chemotherapy within 3 weeks
- Major surgery or radiotherapy within 4 weeks
- Prior participation in any investigational drug study within 3 weeks
- History of allergic reaction to liposome product
- Pregnant or breastfeeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00940758
Start Date
June 1 2009
End Date
June 1 2014
Last Update
April 6 2017
Active Locations (1)
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1
National Cheng Kung University Hospital
Tainan, Taiwan, 704