Open, Randomized Phase II Trial to Investigate the Efficacy and Safety of the PLK-1 Inhibitor BI 2536 in Patients With Advanced, Unresectable Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Intervention: BI 2536
Intervention description: Intravenous Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI
      2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line
      therapy. A secondary aim is to identify the most suitable dosage regimen for the further
      phase II and III clinical programme of BI 2536. To achieve this objective, two dosage
      regimens are compared in patients receiving first line therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. male or female patient aged 18 years or older

          2. patient with confirmed diagnosis of unresectable, either locally advanced or
             metastatic, ductal adenocarcinoma of the pancreas

          3. patient who is either chemonaïve (for the first line cohorts), or who presents with
             progressive disease under first line chemotherapy with a gemcitabine based regimen
             (for the second line cohort)

          4. Karnofsky performance status of ¿ 70% for the first line cohorts, and Karnofsky
             performance status ¿ 50% for the second line cohort

          5. patient with at least one measurable tumour lesion that can accurately be measured by
             magnetic resonance imaging (MRI), or computed tomography (CT) in at least one
             dimension (longest diameter to be recorded)

          6. life expectancy of at least three months

          7. patient must have given written informed consent consistent with the guidelines of the
             international conference on harmonisation for good clinical practice (ICH-GCP) as well
             as with local legislation

        Exclusion Criteria:

          1. prior adjuvant chemotherapy (for first line cohorts only)

          2. ampullary carcinoma of the pancreas

          3. hypersensitivity to the trial drug or the excipients

          4. persistence of toxicities of prior anti cancer therapies which are deemed to be
             clinically relevant

          5. known second malignancy requiring therapy

          6. brain metastases which are symptomatic or require therapy

          7. absolute neutrophil count less than 1.500/mm3

          8. platelet count less than 100.000/mm3

          9. haemoglobin less than 9 mg/dl

         10. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.5
             times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of
             normal in case of known liver metastases

         11. bilirubin greater than 3.0 mg/dl (> 52 ¿mol/l, SI unit equivalent) under adequate
             drainaging measures (in case of obstructive jaundice)

         12. serum creatinine greater than 2.0 mg/dl

         13. concomitant intercurrent illnesses including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness or social situation that would limit compliance
             with trial requirement or which are considered relevant for the evaluation of the
             efficacy or safety of the trial drug

         14. radiotherapy within the past four weeks prior to treatment with the trial drug

         15. hormone- or immunotherapy or therapy with a biologic response modifier within the past
             four weeks

         16. treatment with any other investigational drug within the past four weeks

         17. men or women who are sexually active and unwilling to use a medically acceptable
             method of contraception (e.g. abstinence, condom with spermicidal coating, diaphragm
             with spermicidal coating, oral contraceptive, progesterone implant, sterilisation)
             during the trial

         18. pregnancy or lactation

         19. patients unable to comply with the protocol