A Study Of CP-4126 In Patients With Advanced Pancreatic Cancer

Study Overview

A Study of CP-4126 in Patients With Advanced Pancreatic Cancer

The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.

N/A

Advanced Adenocarcinoma of Pancreas

DRUG: IV CP-4126

CP4126-201

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-06-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-02-09
First Submitted that Met QC Criteria 2009-06-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-02-10
First Posted (ESTIMATED) 2009-06-04	Results First Posted N/A	Last Verified 2012-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: IV CP-4126	DRUG: IV CP-4126 1250 mg/m2/d, IV (in the vein) on day 1, 8 and 15 of each 4 week cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: IV CP-4126

DRUG: IV CP-4126

1250 mg/m2/d, IV (in the vein) on day 1, 8 and 15 of each 4 week cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Primary Outcome Measures	Measure Description	Time Frame
Biological activity of CP-4126 in patients with advanced pancreatic cancer.		Every second cycle

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival, Objective response rate.		Every second cycle - study length

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histological or cytological confirmed advanced pancreatic cancer*
Not eligible for curative resection
Performance Status (ECOG) 0-2
Estimated life expectancy of at least 12 weeks
Age ≥ 18 years
Adequate haematological and biological functions:

Neutrophils ≥ 1.5 x 109/L
Platelets > 100.0 x 109/L
Hb ≥ 10 g/dL
AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
Serum creatinine ≤ 1.5 times institutional ULN
Signed informed consent

Prior chemotherapy for metastatic disease
Symptomatic brain metastases
Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
History of allergic reactions to gemcitabine or egg
Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
Pregnant or breastfeeding women
Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
Known positive status for HIV
Any reason why, in the investigator's opinion, the patient should not participate in the study.
Drug or alcohol abuse
Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record