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 - BI 2536 in advanced metastatic hormone-refractory prostate cancer

Boehringer Ingelheim UK Ltd0 sites50 target enrollmentMarch 3, 2006

ConditionsAdvanced Metastatic Hormone Refractory Prostate Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Metastatic Hormone Refractory Prostate Cancer
Sponsor: Boehringer Ingelheim UK Ltd
Enrollment: 50
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 3, 2006

End Date

February 14, 2008

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Boehringer Ingelheim UK Ltd

Eligibility 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 For a patient who has withdrawn from anti\-androgen therapy less than 6 months prior to inclusion in the trial, one of the following criteria is also required: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.
•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.

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 ?mol/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.