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Prostatic NeoplasmsPhase 2NCT00706498

Phase II Study of BI 2536 in Prostate Cancer

A Phase 2 study testing BI 2536 in people with Prostatic Neoplasms, run by Boehringer Ingelheim at 6 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study to investigate the activity of BI 2536 in Prostate Cancer Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
BI 2536
How many people
20 participants
Where
6 sitesUnited Kingdom
Study dates
Sep 2006to Feb 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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 For a patient who has withdrawn from anti-androgen therapy less than 6 months prior to inclusion in the trial, one of the following criteria is also required: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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

  • 1216.19.4407 Boehringer Ingelheim Investigational Site

    Cambridge

  • 1216.19.4405 Boehringer Ingelheim Investigational Site

    Guildford

  • 1216.19.4402 Boehringer Ingelheim Investigational Site

    Headington

  • 1216.19.4406 The Christie NHS Foundation Trust

    Manchester

  • 1216.19.4404 Boehringer Ingelheim Investigational Site

    Newcastle upon Tyne

  • 1216.19.4401 Boehringer Ingelheim Investigational Site

    Sutton

Other trials in United Kingdom

About this study

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.

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

Being tested
BI 2536
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 2536Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA response rate at 12 weeks according to Prostate Specific Antigen Working Group (PSAWG) criteria.

    Measured: 12 weeks

Secondary outcomes (11)

  1. PSA response duration

    Measured: at least 12 weeks

  2. Time to PSA progression assessed at 24 weeks

    Measured: 24 weeks

  3. Overall objective response using RECIST criteria (complete response [CR] or partial response [PR]) in patients with measurable disease

    Measured: at least 12 weeks

  4. Time to death

    Measured: at least 12 weeks

  5. Time to overall progression

    Measured: at least 12 weeks

  6. Progression free survival

    Measured: at least 12 weeks

  7. Overall survival

    Measured: at least 12 weeks

  8. Duration of overall response (RECIST)

    Measured: at least 12 weeks

  9. BI 2536 plasma concentrations

    Measured: 1 week

  10. 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)

    Measured: 24 weeks

  11. Number of patients with changes in laboratory safety parameters

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2008 (estimated)
  2. Study startSep 2006
  3. Primary completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00706498
Sponsor's protocol ID
1216.19
Status last verified
Apr 2014
First submitted
24 Jun 2008
Last updated
16 May 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 2536 in people with Prostatic Neoplasms, run by Boehringer Ingelheim at 6 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA response rate at 12 weeks according to Prostate Specific Antigen Working Group (PSAWG) criteria. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00706498.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2014.

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