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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00710710
First received: July 3, 2008
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Neoplasms
Drug: BI 2536
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Objective Response (RECIST) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • PFS [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumour control ("objective response" or "stable disease" after the fourth treatment course) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • duration of overall response [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • best response (confirmed and unconfirmed) evaluated according to the RECIST criteria every other course [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • One-year survival [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Carbohydrate antigen (CA)19-9 response [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Quality of life assessment, including clinical benefit response [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Incidence and intensity of AEs graded according to CTCAE [ Time Frame: approximately twice a week ] [ Designated as safety issue: No ]
  • Dose limiting toxicity (DLT) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: August 2006
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710710

Locations
Austria
1216.10.43001 Boehringer Ingelheim Investigational Site
Wien, Austria
Germany
1216.10.49013 Boehringer Ingelheim Investigational Site
Celle, Germany
1216.10.49009 Boehringer Ingelheim Investigational Site
Düsseldorf, Germany
1216.10.49007 Boehringer Ingelheim Investigational Site
Essen, Germany
1216.10.49001 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
1216.10.49005 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1216.10.49010 Boehringer Ingelheim Investigational Site
Herne, Germany
1216.10.49008 Boehringer Ingelheim Investigational Site
München, Germany
1216.10.49003 Boehringer Ingelheim Investigational Site
Stuttgart, Germany
1216.10.49002 Boehringer Ingelheim Investigational Site
Ulm, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00710710     History of Changes
Other Study ID Numbers: 1216.10
Study First Received: July 3, 2008
Last Updated: October 30, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014