An open, randomised, clinical phase II trial in patients with unresectable advanced pancreatic cancer investigating the efficacy, safety, and pharmacokinetics of BI 2536 administered in repeated 3-week cycles as a single i.v. dose of 200 mg on day 1 or as 60 mg doses on days 1, 2, and 3 - BI 2536 in pancreatic cancer

Conditions: patients with unresectable (locally advanced or metastatic) pancreatic cancer, either chemonaive or after first-line chemotherapy with a gemciatbine based regimen

Registration Number: EUCTR2005-005253-22-AT

Lead Sponsor: Boehringer Ingelheim Austria GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 105

Inclusion Criteria

1.)male or female patient aged 18 years or older
2.)patient with confirmed diagnosis of unresectable adenocarcinoma of the pancreas, either locally advanced or with metastases
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.)hypersensitivity to the trial drug or the excipients
2.)prior adjuvant chemotherapy for pancreatic cancer (first line patients only)
3.)persistence of toxicities of prior anti cancer therapies which are deemed to be clinically relevant
4.)known second malignancy requiring therapy
5.)brain metastases which are symptomatic or require therapy
6.)absolute neutrophil count less than 1.500/mm3
7.)platelet count less than 100.000/mm3
8.)haemoglobin less than 9 mg/dl
9.)aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.5 times the upper limit of normal, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times the upper limit of normal in case of known liver metastases
10.)bilirubin greater than 3.0 mg/dl (> 52 ?mol/l, SI unit equivalent) under adequate drainaging measures (in case of obstructive jaundice)
11.)serum creatinine greater than 2.0 mg/dl
12.)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
13.)radiotherapy within the past four weeks prior to treatment with the trial drug
14.)chemo-, hormone- or immunotherapy or therapy with a biologic response modifier within the past four weeks or within less than four half-life times of the previous drug prior to treatment with the trial drug (whichever is longer)
15.)treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whichever is longer)
16.)men or women who are sexually active and unwilling to use a medically acceptable method of contraception during the trial
17.)pregnancy or lactation
18.)patients unable to comply with the protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy, safety and pharmacokinetics of two dosing schedules of BI 2536 in patients with unresectable advanced pancreatic cancer, and to select the most appropriate dosing schedule for the future clinical trials programme<br><br>;Primary end point(s): Primary endpoint:<br>Best objective response evaluated according to the RECIST criteria ;Secondary Objective: 1.)tumour control (= objective response” or stable disease” after the fourth treatment courses), duration of overall response, progression free survival, overall survival, best response (confirmed and unconfirmed) evaluated according to the RECIST criteria every other course <br>2.)one-year survival <br>3.)CA19-9 response<br>4.)quality of life assessment, including clinical benefit response (for definition of clinical benefit response, see section 5.1.8)<br>5.)PK of BI 2536 <br>6.)incidence and intensity of AEs graded according to CTCAE<br>7.)DLT<br>

Secondary Outcome Measures