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

NCT00405210 | Completed Phase 1

• 2 other identifiers: UCL-ONCO 06-003BAY 43-9006/12180
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 6

Brief 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 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.

Conditions

Primary Disease; Prostate Cancer

Keywords

hormone-resistant; metastatic prostatic cancer; pharmacokinetics; naïve patient

Outcome Measures

Primary Outcomes (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.

  after the first 24 patients

Secondary Outcomes (8)

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

  after the first 24 patients

• Toxicity and safety

  at end of study

• Response rate in patients with measurable disease

  at end of study

• PSA response rate

  at end of study

• PSA response duration

  at end of study

Interventions

sorafenib (200 or 400mg bid) and taxotere iv DRUG

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

Also known as: Nexavar

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to beginning protocol specific procedures.
• years
• Radiologically proven presence of metastases
• Histologically/cytologically proven prostate adenocarcinoma.
• Biochemically evaluable disease
• Patients must have received prior hormonal therapy as defined below:
• 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.

You may not qualify if:

• 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)
• 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,…)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (6)

St Pierre

Ottignies, Brabant Wallon, 1340, Belgium

Location

Cliniques Universitaires St Luc

Brussels, Brussels Capital, 1200, Belgium

Location

Notre Dame et Reine Fabiola

Charleroi, Hainaut, 6000, Belgium

Location

Sainte Elisabeth

Namur, Namur, 5000, Belgium

Location

Clinique Universiataire de Mont Godinne

Yvoir, Namur, 5030, Belgium

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sorafenib; BID protein, human

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jean-Pascal H Machiels, Prof

  Cliniques Universitaires St Luc -UCL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: September 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2009
• Last Updated: May 23, 2011

Record last verified: 2011-05

Locations

FR (1); BE (5)