AzTrials
AzTrials

Primary DiseasePhase 1NCT00405210

Pharmacokinetic Study of BAY43-9006 and Taxotere to Treat Patient With Prostatic Cancer

A Phase 1 study testing sorafenib (200 or 400mg bid) and taxotere iv in people with Primary Disease and Prostate Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 6 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the trial is to determine the most effective dose of BAy 46-9003 associated to taxotere for first-line treatment of patient with prostatic cancer. BAY 43-9006 (SORAFENIB) is a novel dual-action Raf kinase and VEGFR inhibitor, which is orally available and has a favorable safety profile in patients with… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Primary Disease, Prostate Cancer
What is being tested?
sorafenib (200 or 400mg bid) and taxotere iv
Type of treatment
Injection or infusion
How many people
38 participants
Where
6 sitesin 2 countries
Study dates
Sep 2006to Dec 2009
Phase
Phase 1
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

  • Signed informed consent prior to beginning protocol specific procedures.
  • 18 years
  • Radiologically proven presence of metastases
  • Histologically/cytologically proven prostate adenocarcinoma.
  • Biochemically evaluable disease
  • Patients must have received prior hormonal therapy as defined below:
Show all 13Show fewer
  • Castration by orchiectomy and/or LHRH agonists with or without
  • Antiandrogens
  • Other hormonal agents (e.g., ketoconazole, ...)
  • The testosterone level should be < 50 ng/dl (10) documented disease progression defined by PSA increase. Patients must have a value of at least 5 ng/ml in addition to increasing PSA to be eligible.
  • Life expectancy > 3 months
  • ECOG performance status 0-2.
  • Normal cardiac function.

Who cannot join

  • Prior chemotherapy except estramustine phosphate.
  • Prior isotope therapy (e.g., strontium, samarium).
  • Prior radiotherapy to >25% of bone marrow
  • Prior therapy with anti-VEGF therapy
  • Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years.
  • History or presence of central nervous system (CNS) disease (i.e. primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis)
Show all 22Show fewer
  • Symptomatic peripheral neuropathy
  • Other serious illness or medical condition the use of corticosteroids.
  • Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BAY 9006.
  • Major surgery with 4 weeks of study entry
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
  • Use of biologic response modifiers, such as G-CSF, within 3 weeks of study entry
  • Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped.
  • Treatment with drugs that are metabolized by the cytochrome P450 system (i.e warfarin sodium,…)
  • Treatment with systemic corticosteroids used for reasons other than specified by the protocol must be stopped.
  • Biphosphonates could not be initiated after inclusion into the protocol. At inclusion, patients receiving biphosphonates with a PSA progression could continue biphosphonates.
  • Patients with reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial.
  • Inadequate recovery from previous surgery, radiation, chemo-, biologic or immunotherapy
  • Patients who have known hypersensitivity to the study medication
  • Substance abuse, medical social, psychological conditions that may interfere with the subject's participation in the study or evaluation of study results
  • Patients unable to sallow oral medications.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Belgium5 sites

  • Cliniques Universitaires St Luc

    Brussels, Brussels Capital, 1200

  • Notre Dame et Reine Fabiola

    Charleroi, Hainaut, 6000

  • Sainte Elisabeth

    Namur, Namur, 5000

  • St Pierre

    Ottignies, Brabant Wallon, 1340

  • Clinique Universiataire de Mont Godinne

    Yvoir, Namur, 5030

Other trials in Belgium

France1 site

  • Hôpital Européen Georges Pompidou

    Paris, 75015

Other trials in France

About this study

Official title: Open-label, Multicenter,PhaseI Trial in Order To Determine the Safety and Pharmacokinetics of BAY43-9006 in Combination With Docetaxel as First-line Treatment in Metastatic Hormone Refractory Prostate Cancer Patients

The purpose of the trial is to determine the most effective dose of BAy 46-9003 associated to taxotere for first-line treatment of patient with prostatic cancer.

BAY 43-9006 (SORAFENIB) is a novel dual-action Raf kinase and VEGFR inhibitor, which is orally available and has a favorable safety profile in patients with advanced solid tumors. This, together with the antitumor activity observed after treatment with BAY 43-9006 (SORAFENIB), provides a rationale for further evaluation in patients with advanced cancer. The recommended dose of BAY 43-9006 (SORAFENIB) for future studies is 400 mg bid as a continuous dosing schedule.

Read the detailed description

This study propose to treat patients with metastatic and hormone-refractory prostatic cancer in first intention. There is no limits of age from 18 years old. A new inhibitor of angiogenesis (Sorafenib) is associated to the standard treatment in this type of pathology.

Patients have to demonstrate radiologically a disease progression and also a progression based on increase of psa level.

The main objective is to Determine the recommended dose of BAY 43-9006 in combination with docetaxel in hormone-refractory prostate cancer patients as first line treatment in patients with metastatic hormone-refractory prostate cancer.

Being tested
sorafenib (200 or 400mg bid) and taxotere iv
Keywords
hormone-resistant, metastatic prostatic cancer, pharmacokinetics, naïve patient
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • sorafenib (200 or 400mg bid) and taxotere ivDrug

    Also called Nexavar

    200 mg BID, day 3-19 cycle 1, day 2-19 other cycles 200 mg BID, day 3-21 Cycle 1, day 1-21 other cycles 400 mg BID, day 3-19 cycle 1, day 2-19 other cycles 400 mg BID, day 3-21 cycle 1, day 1-21 other cycles

What is being measured

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

  1. Determine the recommended dose of BAY 43-9006 (SORAFENIB) in combination with docetaxel in hormone-refractory prostate cancer patients as first line treatment in patients with metastatic hormone refractory prostate cancer.

    Measured: after the first 24 patients

Secondary outcomes (8)

  1. Evaluation of pharmacokinetics and pharmacodynamics of BAY43-9006 in combination with docetaxel*

    Measured: after the first 24 patients

  2. Toxicity and safety

    Measured: at end of study

  3. Response rate in patients with measurable disease

    Measured: at end of study

  4. PSA response rate

    Measured: at end of study

  5. PSA response duration

    Measured: at end of study

  6. Time to PSA progression (=time between treatment start and PSA progression)

    Measured: at end of study

  7. Time to PSA progression after the last dose of docetaxel in patients with no progression after stopping docetaxel (= time between the last dose of docetaxel and PSA progression)

    Measured: at end of study

  8. Event progression-free survival

    Measured: at end of study

Timeline

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

  1. First posted29 Nov 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionAug 2008
  4. Study completionDec 2009

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00405210
Sponsor's protocol ID
UCL-ONCO 06-003
Other IDs
BAY 43-9006/12180
Status last verified
May 2011
First submitted
28 Nov 2006
Last updated
23 May 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sorafenib (200 or 400mg bid) and taxotere iv in people with Primary Disease and Prostate Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 6 sites in 2 countries.

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 13 inclusion and 22 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 23 May 2011. 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 Belgium, France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Determine the recommended dose of BAY 43-9006 (SORAFENIB) in combination with docetaxel in hormone-refractory prostate cancer patients as first line treatment in patients with metastatic hormone refractory prostate cancer. (time frame: after the first 24 patients). 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 NCT00405210.

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 23 May 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in