A phase II study of CP-4126 in patients with advanced pancreatic cancer - CP4126-201

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Histological or cytological confirmed advanced pancreatic adenocarcinoma*
2. Pre-treatment serum CA 19-9 = 1.5 x ULN
3. Performance status (ECOG) 0-2
4. Estimated life expectancy of at least 12 weeks
5. Age = 18 years
6. Adequate haematological and biological functions:
• Bone marrow function:
a. Neutrophils = 1.5 x 109/L
b. Platelets > 100.0 x 109/L
c. Hb = 10 g/dL
• Hepatic function:
a. 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
b. Bilirubin = 1.5 times institutional ULN, if liver metastases = 3 x institutional ULN
• Renal function:
a. Serum creatinine = 1.5 times institutional ULN
7. Signed informed consent
* When feasible, the biopsy for diagnosis and hENT1 can be combined, so that the patient only needs to have one biopsy performed.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior chemotherapy for metastatic disease
2. Symptomatic brain metastases
3. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
4. Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
5. History of allergic reactions to gemcitabine or egg
6. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance
8. Pregnant or breastfeeding women
9. 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
10. Known positive status for HIV
11. Any reason why, in the investigator’s opinion, the patient should not participate in the study.
12. Drug or alcohol abuse
13. Radical resection less than one year prior to inclusion in the study. Exploratory laparotomy as well palliative (e.g. bypass) surgery are allowed

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to assess the biological activity of CP-4126 vs gemcitabine in patients with advanced pancreatic cancer.<br><br>;Secondary Objective: The correlation between hENT1 (human equilibrative nucleoside transporter 1) in tumour tissue and response will be measured as change in tumour marker CA 19-9 and objective response in addition to overall survival<br>;Primary end point(s): • CA 19-9 responses<br>

Secondary Outcome Measures

Name	Time	Method

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