- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00569153
Safety Study of TAK-700 in Subjects With Prostate Cancer. (TAK-700)
A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects
Přehled studie
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Studijní místa
-
-
California
-
Beverly Hills, California, Spojené státy
- USC Westside Prostate Cancer Center
-
Los Angeles, California, Spojené státy
- USC Norris Comprehensive Cancer Center
-
Los Angeles, California, Spojené státy, 90048
- University of Southern California
-
Los Angeles, California, Spojené státy
- The Angeles Clinic and Research Institute
-
-
Florida
-
Aventura, Florida, Spojené státy
- South Florida Medical Research
-
Fort Myers, Florida, Spojené státy
- Florida Cancer Specialists
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60637
- University of Chicago
-
Chicago, Illinois, Spojené státy, 60611
- Northwestern University Medical Center
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Chicago, Illinois, Spojené státy
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Spojené státy
- University of Chicago Pharmacy
-
Evanston, Illinois, Spojené státy
- Evanston Hospital
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Evanston, Illinois, Spojené státy
- NorthShore University HealthSystem
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Evanston, Illinois, Spojené státy
- Kellogg Pharmacy - Evanston Hospital
-
Glenview, Illinois, Spojené státy
- Kellogg Cancer Care Center
-
-
New York
-
East Syracuse, New York, Spojené státy
- Hematology/Oncology Associates of Central New York
-
-
Ohio
-
Canton, Ohio, Spojené státy
- Gabrail Cancer Center
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic
-
Cleveland, Ohio, Spojené státy
- Taussig Cancer Institute
-
-
Tennessee
-
Nashville, Tennessee, Spojené státy
- Tennessee Oncology
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Subject is male and at least 18 years of age.
- Subject has histologically- or cytologically-confirmed prostate adenocarcinoma with metastatic, progressive disease while on androgen deprivation therapy.
- Subject has radiograph-documented (computed tomography, magnetic resonance imaging or x-ray) metastatic disease.
- Subject has undergone orchiectomy or is expected to continue receiving luteinizing hormone-releasing hormone analogue therapy, and has a testosterone level of <50 ng/dL at screening.
- Subject has discontinued all antiandrogen therapy (within 30 days for flutamide and within 6 weeks for all others) prior to their first dose of study drug.
- Subject has a prostate-specific antigen level ≥5 ng/mL.
- Subject meets all screening laboratory values as specified in the protocol.
- Subject has a screening ejection fraction that is above the lower limit of the institutional normal range.
- Subject has ECOG performance status of 0 to 2.
- Subject has normal or, in the opinion of the investigator, clinically insignificant, physical examination findings, ECG and chest x-ray results.
- Subjects, even if surgically sterilized (ie, status postvasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
Exclusion Criteria:
- Subject has known hypersensitivity to TAK-700 or related compounds.
- Subject has received prior therapy with aminoglutethimide or ketoconazole within 30 days prior to the first dose of study drug.
- Subject has received prior chemotherapy for prostate cancer.
- Subject has received any investigational compound within 30 days prior to first dose of study drug.
- Subject has received prior herbal product known to decrease prostate-specific antigen levels (eg, Saw Palmetto, PC-SPES) within 30 days prior to the first dose of study drug.
- Subject has received radiation therapy for prostate cancer within 30 days prior to first dose of study drug.
- Chronic therapy with oral or other systemically administered corticosteroids, such as prednisone, within 30 days prior to Screening. Chronic therapy is defined as the use of corticosteroids for more than 7 days within a 30-day period.
- Subject has current spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction.
- Subject has a history of adrenal insufficiency.
- Subject has a history of myocardial infarction, ischaemic symptomatic heart disease, cardiac arrhythmias or thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 12 months prior to first dose of study drug.
- Subject has any symptoms which the investigator deems related to prostate cancer, i.e., bone pain, pelvic pain.
- Subject has a history of congestive heart failure (New York Heart Association Class II or greater.
- Subject has history of another malignancy other than basal cell carcinoma or state 1 squamous cell carcinoma of the skin, within the last 5 years.
- Subject has uncontrolled hypertension.
- Subject is known to have HIV infection, chronic Hepatitis B or C or any other serious medical condition or psychiatric illness that might affect life expectancy or make it difficult to successfully manage and follow the subject according to protocol.
- Subject is unable to understand verbal or written English or any other language for which a certified translation of the institutional review board (IRB)-approved informed consent has been provided.
- Subject is unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Arm 1 (TAK-700)
|
Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments:
|
Experimentální: Arm 2 (TAK-700 at 400 mg & 5 mg prednisone)
|
Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments:
|
Experimentální: Arm 3 (TAK-700 at 600 mg & 5 mg prednisone)
|
Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments:
|
Experimentální: Arm 4 (TAK-700 at 600 mg)
|
Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Časové okno: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
|
Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Efficacy and pharmacokinetics (PSA response and/or objective disease response)
Časové okno: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
|
Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- TAK-700_201
- TAK-700-201
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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