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

Phase 2
18 Years
Not Enrolling
Advanced Adenocarcinoma of Pancreas

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Trial Information

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Biological activity of CP-4126 in patients with advanced pancreatic cancer.

Outcome Time Frame:

Every second cycle

Safety Issue:



Norway: Norwegian Medicines Agency

Study ID:




Start Date:

April 2009

Completion Date:

September 2011

Related Keywords:

  • Advanced Adenocarcinoma of Pancreas
  • Pancreas
  • Advanced adenocarcinoma
  • CP-4126
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms