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

NCT00710710 | Completed Phase 2 Results

• 1 other identifier: 1216.10
• Study Type: interventional
• Target: 89
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Best Objective Response Evaluated According to the RECIST Criteria by Independent Review

  Best objective response: Tumour assessment by independent review of tumour imaging by an external contract research organization (CRO) according to Response Evaluation Criteria In Solid Tumours (RECIST) after every second treatment course, including imaging (e.g. Computed tomography (CT), Magnetic resonance imaging (MRI)) and submission of image(s) to central imaging unit. Complete remission (CR): Disappearance of all target lesions for at least 4 weeks from the documentation of CR. Partial remission (PR): At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum Longest Diameter (LD). Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as references the smallest sum LD since the treatment started. No best response: includes all RECIST categories which are considered as failing to respond to therapy, e.g. progressive disease, death or unknown.

  Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

Secondary Outcomes (11)

• Tumour Control After the Fourth Treatment Course

  Tumour measurements performed at screening (day -21 to -1) and at the end of of the fourth 3-week treatment cycle, up to 105 days.

• Duration of Overall Response

  Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

• Progression Free Survival (PFS)

  Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

• Overall Survival (OS)

  From first treatment till the end of the trial or when a patient concluded the trial, up to 336 days.

• Best Objective Response Evaluated According to the RECIST Criteria by Investigator Assessment

  Tumour measurements performed at screening (day -21 to -1), at the end of every other treatment period (2x 3 weeks), and at the end of the trial or when a patient concluded the trial, up to 357 days.

Study Arms (2)

BI 2536 High dose

EXPERIMENTAL

Day 1

Drug: BI 2536

BI 2536 Low dose

EXPERIMENTAL

Day 1 - 3

Drug: BI 2536

Interventions

BI 2536 DRUG

Intravenous Infusion

BI 2536 High dose; BI 2536 Low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

1216.10.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1216.10.49013 Boehringer Ingelheim Investigational Site

Celle, Germany

Location

1216.10.49009 Boehringer Ingelheim Investigational Site

Düsseldorf, Germany

Location

1216.10.49007 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

1216.10.49001 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, Germany

Location

1216.10.49005 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1216.10.49010 Boehringer Ingelheim Investigational Site

Herne, Germany

Location

1216.10.49008 Boehringer Ingelheim Investigational Site

München, Germany

Location

1216.10.49003 Boehringer Ingelheim Investigational Site

Stuttgart, Germany

Location

1216.10.49002 Boehringer Ingelheim Investigational Site

Ulm, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

BI 2536

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 4, 2008
• Study Start: August 1, 2006
• Primary Completion: October 14, 2008
• Study Completion: October 14, 2008
• Last Updated: May 4, 2022
• Results First Posted: May 4, 2022

Record last verified: 2022-04

Locations

AU (1); DE (9)