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

Phase 1

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: PEP02

• Registration Number: NCT00940758
• Lead Sponsor: PharmaEngine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Primary Completion: 2012-05
• Study Completion: 2014-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEP02	PEP02	-

Primary Outcome Measures

Name	Time	Method
To evaluate the DLT and the toxicity profile	3 years
To establish the MTD	3 years
To characterize the pharmacokinetics of biweekly PEP02 in patients with metastatic colorectal cancer who failed to first-line oxaliplatin-based chemotherapy	3 years

Secondary Outcome Measures

Name	Time	Method
To collect data for preliminary evaluation of tumor response	3 years
To explore the association of the pharmacogenetics of PEP02 including UGT1A family - UGT1A1 and UGT1A9 with pharmacokinetic parameters and toxicity	3 years

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan