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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.

Conditions
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Advanced Adenocarcinoma of Pancreas

Intervention / Treatment
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* Drug: IV CP-4126


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV CP-4126<br> | Drug: IV CP-4126<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreas, Advanced adenocarcinoma, CP-4126