Advanced Adenocarcinoma of Pancreas
Conditions
Keywords
Pancreas, Advanced adenocarcinoma, CP-4126
Brief summary
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.
Interventions
DRUGIV 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.
Sponsors
Clavis Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biological activity of CP-4126 in patients with advanced pancreatic cancer. | Every second cycle |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Objective response rate. | Every second cycle - study length |
Countries
Belgium, Norway
Outcome results
None listed