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

PharmaEngine

Status and phase

Completed

Phase 1

Conditions

Metastatic Colorectal Cancer

Treatments

Drug: PEP02

Study type

Interventional

Funder types

Industry

Identifiers

NCT00940758

PIST-CRC-01

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)