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

NCT00940758 | Completed Phase 1

• 1 other identifier: PIST-CRC-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (1)

PEP02

EXPERIMENTAL

Drug: PEP02

Interventions

PEP02 DRUG

Dose escalation: 50-100 mg/m2 biweekly

PEP02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• PharmaEngine: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 16, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2014
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

TW (1)