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

NCT ID: NCT00940758

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEP02

Group Type: EXPERIMENTAL

PEP02

Intervention Type: DRUG

Dose escalation: 50-100 mg/m2 biweekly

Interventions

PEP02

Dose escalation: 50-100 mg/m2 biweekly

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaEngine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

PIST-CRC-01

Identifier Type: -

Identifier Source: org_study_id