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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Pancreatic Neoplasms

Treatments

Drug: BI 2536

Study type

Interventional

Funder types

Industry

Identifiers

NCT00710710

1216.10

Details and patient eligibility

About

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.

Enrollment

89 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male or female patient aged 18 years or older
patient with confirmed diagnosis of unresectable, either locally advanced or metastatic, ductal adenocarcinoma of the pancreas
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)
Karnofsky performance status of ¿ 70% for the first line cohorts, and Karnofsky performance status ¿ 50% for the second line cohort
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)
life expectancy of at least three months
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

prior adjuvant chemotherapy (for first line cohorts only)
ampullary carcinoma of the pancreas
hypersensitivity to the trial drug or the excipients
persistence of toxicities of prior anti cancer therapies which are deemed to be clinically relevant
known second malignancy requiring therapy
brain metastases which are symptomatic or require therapy
absolute neutrophil count less than 1.500/mm3
platelet count less than 100.000/mm3
haemoglobin less than 9 mg/dl
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
bilirubin greater than 3.0 mg/dl (> 52 ¿mol/l, SI unit equivalent) under adequate drainaging measures (in case of obstructive jaundice)
serum creatinine greater than 2.0 mg/dl
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
radiotherapy within the past four weeks prior to treatment with the trial drug
hormone- or immunotherapy or therapy with a biologic response modifier within the past four weeks
treatment with any other investigational drug within the past four weeks
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
pregnancy or lactation
patients unable to comply with the protocol