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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clavis Pharma

Criteria

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