Phase II Study of BI 2536 in Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00706498
First received: June 24, 2008
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

A study to investigate the activity of BI 2536 in Prostate Cancer


Condition Intervention Phase
Prostatic Neoplasms
Drug: BI 2536
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Single Arm Phase II Study to Investigate the Efficacy, Safety and Pharmacokinetics of a Single Dose of 200 mg of i.v. BI 2536, Administered Once Every 3 Weeks in Patients With Advanced Metastatic Hormone-refractory Prostate Cancer.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • PSA response rate at 12 weeks according to Prostate Specific Antigen Working Group (PSAWG) criteria. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA response duration [ Time Frame: at least 12 weeks ] [ Designated as safety issue: No ]
  • Time to PSA progression assessed at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Overall objective response using RECIST criteria (complete response [CR] or partial response [PR]) in patients with measurable disease [ Time Frame: at least 12 weeks ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: at least 12 weeks ] [ Designated as safety issue: No ]
  • Time to overall progression [ Time Frame: at least 12 weeks ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: at least 12 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: at least 12 weeks ] [ Designated as safety issue: No ]
  • Duration of overall response (RECIST) [ Time Frame: at least 12 weeks ] [ Designated as safety issue: No ]
  • BI 2536 plasma concentrations [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Incidence and intensity of AEs, with grading according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, version 3.0) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of patients with changes in laboratory safety parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2006
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male patient age >18 years.
  • Signed informed consent.
  • Able to comply with protocol requirements.
  • Patients with histologically, cytologically or biochemically documented metastatic adenocarcinoma of the prostate, clinically refractory or resistant to hormone therapy, as documented by progression following at least one hormonal therapy, which must include orchidectomy or gonadotropin releasing hormone agonist (GnRHa).
  • Patients with Progressive Disease (PD). PD is defined as a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which document progressively increasing PSA values. Patients with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression.
  • Patients must have documented progression (as defined above) following anti-androgen withdrawal of 4 weeks duration for flutamide and 6 weeks for bicalutamide or nilutamide. For a patient who has withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the trial, one of the following criteria is also required:
  • Following completion of the anti-androgen withdrawal period one PSA measurement should be higher than the last pre-withdrawal PSA.

Or

  • Following the completion of the anti-androgen withdrawal period if the PSA value has decreased, a patient can still qualify if 2 increases in PSA are documented after the post- withdrawal nadir.
  • PSA > 10 ng/ml.
  • A predicted life expectancy of at least 12 weeks.
  • A maximum of one prior treatment with either chemotherapy or other non-hormonal treatment modality.
  • ECOG performance status 0-1.
  • Stable analgesia requirements.
  • INR Prothrombin time (PT) and partial thromboplastin time (PTT) <1.5 upper limit of normal.
  • Adequate bone marrow function defined as absolute neutrophil count (ANC) > 1.5 x 109l, Platelet count > 100 x 109/l.
  • Haemoglobin > 9.0 mg/dl.
  • Serum Albumin > 2.0 g/l.
  • Castrate testosterone level [< 20 ng/dl or <0.69nM (nM/L x 28.8 = ng/dl)] must be maintained during the duration of the trial by orchidectomy or medical castration.
  • Patients on oral or intravenous bisphosphonates are allowed to enter the trial as long as they have been on bisphosphonates for a minimum of 3 months.

Exclusion Criteria:

  • Prior treatment with more than one cytotoxic chemotherapy regimen.
  • Known or suspected hypersensitivity to the trial drug or their excipients.
  • Persistence of toxicities of prior anti-cancer therapies which are deemed to be clinically relevant.
  • Aspartate amino transferase (ast) or alanine amino transferase (alt) greater than 2.5 times the upper limit of normal, or aspartate amino transferase (ast) or alanine amino transferase (alt) greater than 5 times the upper limit of normal in case of known liver metastases.
  • Bilirubin greater than 1.5 mg/dl (> 26 micromol/l, Si unit equivalent). Serum creatinine greater than 2.0 g/l.
  • 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.
  • Systemic corticosteroids taken within the past 28 days before screening (inhaled corticosteroids prescribed for bronchospasm are allowed). Patients on long-term stable-dose steroids for concurrent illness are not excluded.
  • Treatment with any investigational drug within 28 days of trial onset.
  • History of other malignancies which could affect compliance with the protocol or interpretation of results within 5-years. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
  • Patient with history or clinical evidence of CNS disease or brain metastases.
  • Patients with symptoms of impending or established spinal cord compression.
  • Radiotherapy within the past four weeks prior to treatment with the trial drug.
  • Prior radioisotope therapy (except radium-223 which is permissible).
  • Immunotherapy within the past four weeks prior to treatment with the trial drug.
  • Patients unable to comply with the protocol.
  • Active alcohol or drug abuse.
  • Patients who do not use adequate contraception.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706498

Locations
United Kingdom
1216.19.4407 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
1216.19.4405 Boehringer Ingelheim Investigational Site
Guildford, United Kingdom
1216.19.4402 Boehringer Ingelheim Investigational Site
Headington, United Kingdom
1216.19.4406 The Christie NHS Foundation Trust
Manchester, United Kingdom
1216.19.4404 Boehringer Ingelheim Investigational Site
Newcastle Upon Tyne, United Kingdom
1216.19.4401 Boehringer Ingelheim Investigational Site
Sutton, United Kingdom
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: NCT00706498     History of Changes
Other Study ID Numbers: 1216.19
Study First Received: June 24, 2008
Last Updated: April 30, 2014
Health Authority: Great Britain: MHRA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014