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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Outcome Measure:

Objective Response (RECIST)

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

1216.10

NCT ID:

NCT00710710

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Pancreatic Neoplasms
  • Neoplasms
  • Pancreatic Neoplasms

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