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Adenocarcinoma of the ProstatePhase 2NCT00430235

A Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer

A Phase 2 study testing BAY 43-9006 in people with Adenocarcinoma of the Prostate, run by British Columbia Cancer Agency at 1 site in Canada.

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

Purpose: To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve hormone-refractory prostate cancer. Hypothesis: That there will be PSA response when BAY 43-9006 in combination with bicalutamide is given to patients with chemo-naïve hormone-refractory prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Adenocarcinoma of the Prostate
What is being tested?
BAY 43-9006
How many people
39 participants
Where
1 siteCanada
Study dates
Mar 2007to Aug 2010
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

  • Patients must have a histologic or cytologic diagnosis of adenocarcinoma of the prostate.
  • Patients must have low-bulk asymptomatic metastatic or biochemical recurrent disease for which no curative therapy exists.
  • Patients must have documented evidence of PSA progression while receiving androgen ablative therapy, i.e. must be hormone refractory.
  • The PSA must be > 5 μg/L at the time of study entry.
  • ECOG performance status of 0 or 1.
  • Age 18 years of age or older
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  • Patients must have a life expectancy of at least 12 weeks.
  • Chemotherapy: No prior cytotoxic chemotherapy is permissible. Neoadjuvant or adjuvant chemotherapy is permissible provided it was > 12 months prior to registration.
  • Hormonal Therapy:
  • Prior hormone therapy in the form of medical or surgical castration is required. Patients must be hormone refractory and have been previously and currently treated with androgen ablative therapy.
  • Patients may have received up to one line of non-steroidal anti- androgens in combination with chemical or surgical castration. Use of prior Bicalutamide is restricted to less than 3 months of continuous usage. Patients must be off anti-androgens for at least 6 weeks prior to study entry.
  • Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial.
  • Steroids. Current treatment with steroids ≤ an equivalent of prednisone 20 mg day is permitted.
  • Men of childbearing potential must use an effective form of contraception i.e. double barrier method.
  • Laboratory Requirements - within 7 days prior to enrollment Hematology: Hemoglobin ≥ 100g/L Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR ≤ 1.5 x upper limit of normal Biochemistry: AST, ALT within normal limits Bilirubin within normal limits Serum creatinine ≤1.5 x upper limit of normal
  • 15. Patient consent must be obtained 16. Patients must be accessible for treatment and follow-up. 17. Protocol treatment is to begin within 5 working days of patient registration.

Who cannot join

  • Prior use of BAY 43-9006 or other VEGF/VEGFR or EGFR targeting agents.
  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for > 5 years.
  • Patients with known brain metastases or leptomeningeal disease
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006 or other agents used in the study.
  • Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment including:myocardial infarction within 6 months prior to study entry:
  • myocardial infarction within 6 months prior to study entry
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  • congestive heart failure
  • unstable angina
  • cardiomyopathy
  • unstable ventricular arrhythmia
  • uncontrolled hypertension (systolic blood pressure ≥ 160, diastolic blood pressure ≥100)
  • controlled psychotic disorders
  • serious infections
  • peptic ulcer disease
  • history of bleeding diathesis
  • Upper gastrointestinal or other conditions that would preclude compliance with oral medication.
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-9006. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
  • Patients who require large amounts of narcotic therapy to control pain (e.g. morphine equivalent dose > 30 mg/day) since these patients would more appropriately be offered systemic chemotherapy.
  • Patients who require therapeutic anticoagulation.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase II Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer

Purpose:

To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve hormone-refractory prostate cancer.

Hypothesis:

That there will be PSA response when BAY 43-9006 in combination with bicalutamide is given to patients with chemo-naïve hormone-refractory prostate cancer.

Read the detailed description

Justification:

The biologic and clinical activity and tolerability of BAY 43-9006, the therapeutic needs of the proposed patient population, and the experimental evidence in support of targeting the VEGF/VEGFR and MAPK pathways in combination with androgen receptor blockade in prostate cancer, provides a strong rationale for the proposed phase II trial to evaluate the tolerability and anti-cancer activity of combined treatment with the non-steroidal anti-androgen bicalutamide with the multi-targeted kinase inhibitor BAY 43-9006 in patients with prostate cancer that is progressing after castration therapy.

Objectives:

The primary study objective is to define the efficacy (i.e. post treatment decrement in PSA (PSA response)) of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve hormone-refractory prostate cancer.

Secondary Objectives:

  • To determine the safety and tolerability of BAY 43-9006 given in combination with bicalutamide in patients with HRPC.
  • To determine the time to treatment failure, PSA progression and disease progression in HRPC patients treated with BAY 43-9006 in combination with bicalutamide.
  • To determine objective response rates in HRPC patients with measurable disease treated with BAY 43-9006 in combination with bicalutamide.

Research Method:

This is a phase II clinical trial in patients with androgen independent prostate cancer which will evaluate the therapeutic activity and safety profile of BAY 43-9006 given orally at the recommended phase II dose of 400 mg PO BID continuously in combination with bicalutamide 50 mg PO daily continuously. Each 4 week period will be considered 1 cycle. Doses will be adjusted for toxicity.

Statistical Analysis:

Primary Endpoint The primary endpoint for this study will be the rate of PSA-response of the combination for patients with rising PSA post castration therapy.

Secondary Endpoints:

Secondary endpoints will include time to treatment failure, time to PSA progression, duration of PSA response, median survival time, 1 year survival rate, objective tumor response rate and stable disease rate as defined by the RECIST criteria, response duration, and incidence of toxicities by NCI CTCAE.

Being tested
BAY 43-9006
Keywords
prostate, cancer, BAY 43-9006
Medical subject headings
Neoplasms

What participants receive

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

  • BAY 43-9006Drug

    BAY 43-9006, 400 mg, PO, BID in a 28-day cycle(morning and evening) Bicalutamide 50 mg po Once daily in a 28-day cycle (morning)

What is being measured

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

  1. rate of PSA-response

Secondary outcomes (9)

  1. time to treatment failure

  2. time to PSA progression

  3. duration of PSA response

  4. median survival time

  5. 1 year survival rate

  6. objective tumor response rate

  7. stable disease rate as defined by the RECIST criteria,

  8. response duration

  9. incidence of toxicities by NCI CTCAE.

Timeline

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

  1. First posted1 Feb 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionAug 2010

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00430235
Sponsor's protocol ID
OZM-001
Status last verified
Aug 2010
First submitted
30 Jan 2007
Last updated
5 Aug 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY 43-9006 in people with Adenocarcinoma of the Prostate, run by British Columbia Cancer Agency at 1 site in Canada.

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 16 inclusion and 19 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 5 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

rate of PSA-response. 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 NCT00430235.

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 5 Aug 2010.

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