Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaEngine
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)