Phase II Study of BI 2536 in Prostate Cancer

NCT ID: NCT00706498

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30

Brief Summary

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

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Interventions

BI 2536

Intervention Type: DRUG

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 For a patient who has withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the trial, one of the following criteria is also required: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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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

Countries

United Kingdom

Other Identifiers

1216.19

Identifier Type: -

Identifier Source: org_study_id