- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00405210
Pharmacokinetic Study of BAY43-9006 and Taxotere to Treat Patient With Prostatic Cancer
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Namur, Belgien, 5000
- Sainte Elisabeth
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Brabant Wallon
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Ottignies, Brabant Wallon, Belgien, 1340
- St Pierre
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Brussels Capital
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Brussels, Brussels Capital, Belgien, 1200
- Cliniques Universitaires St Luc
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Hainaut
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Charleroi, Hainaut, Belgien, 6000
- Notre Dame et Reine Fabiola
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Namur
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Yvoir, Namur, Belgien, 5030
- Clinique Universiataire de Mont Godinne
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Paris, Frankrig, 75015
- Hôpital Européen Georges Pompidou
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- 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,…)
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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.
Tidsramme: after the first 24 patients
|
after the first 24 patients
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluation of pharmacokinetics and pharmacodynamics of BAY43-9006 in combination with docetaxel*
Tidsramme: after the first 24 patients
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after the first 24 patients
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Toxicity and safety
Tidsramme: at end of study
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at end of study
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Response rate in patients with measurable disease
Tidsramme: at end of study
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at end of study
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PSA response rate
Tidsramme: at end of study
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at end of study
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PSA response duration
Tidsramme: at end of study
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at end of study
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Time to PSA progression (=time between treatment start and PSA progression)
Tidsramme: at end of study
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at end of study
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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)
Tidsramme: at end of study
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at end of study
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Event progression-free survival
Tidsramme: at end of study
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at end of study
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Jean-Pascal H Machiels, Prof, Cliniques Universitaires St Luc -UCL
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Genitale neoplasmer, mandlige
- Prostatasygdomme
- Prostatiske neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Proteinkinasehæmmere
- Docetaxel
- Sorafenib
Andre undersøgelses-id-numre
- UCL-ONCO 06-003
- BAY 43-9006/12180
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