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

Sponsor

PharmaEngine (Industry)

Overall Status

Completed

CT.gov ID

NCT00940758

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Drug: PEP02	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I and Pharmacokinetic Study of Biweekly PEP02 (Liposome Irinotecan) in Patients With Metastatic Colorectal Cancer Refractory to First-line Oxaliplatin-based Chemotherapy

Actual Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEP02	Drug: PEP02 Dose escalation: 50-100 mg/m2 biweekly

Arm

Intervention/Treatment

Experimental: PEP02

Drug: PEP02

Dose escalation: 50-100 mg/m2 biweekly

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cheng Kung University Hospital	Tainan		Taiwan	704

Sponsors and Collaborators

PharmaEngine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PharmaEngine

ClinicalTrials.gov Identifier:

NCT00940758

Other Study ID Numbers:

PIST-CRC-01

First Posted:

Jul 16, 2009

Last Update Posted:

Apr 6, 2017

Last Verified:

Apr 1, 2017

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Apr 6, 2017