- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01685125
Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
A Randomized Phase II Trial of Dasatinib Plus Abiraterone Compared to Abiraterone Alone for Metastatic, Castration-Resistant Prostate Cancer Prior to Chemotherapy
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
PRIMARY OBJECTIVES:
I. To compare the progression-free survival of men with metastatic castration-resistant prostate cancer treated with abiraterone (abiraterone acetate) plus dasatinib to that of men treated with abiraterone alone.
SECONDARY OBJECTIVES:
I. To describe the toxicity profile of the combination, as well as the rate of prostate-specific antigen (PSA) response, objective responses, and changes in circulating tumor cell (CTC) numbers.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive abiraterone acetate 1000 mg orally (PO) once daily (QD) and prednisone 5 mg PO twice daily (BID) on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive abiraterone acetate and prednisone as patients in arm A. Patients also receive dasatinib 100 mg PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
-
-
California
-
Los Angeles, California, Spojené státy, 90033
- USC Norris Comprehensive Cancer Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Metastatic, castration-resistant prostate cancer
- Defined as evaluable radiographic disease with rising PSA x 2 (at least 1 week apart) or radiographic progression (new soft tissue/bone lesions or enlarging soft tissue lesions) despite medical or surgical castration
- No limit on prior hormonal therapies (i.e. anti-androgens, ketoconazole) except that subject must not have received abiraterone previously
- No limit on prior biologic therapies (i.e. immune therapy, antiangiogenic, targeted) except that patient should not have received dasatinib or other v-src sarcoma (Schmidt-Ruppin A-2) viral oncogene homolog (avian) (src)-targeted therapy
No prior chemotherapy for metastatic disease
* Subjects who have received chemotherapy in the neoadjuvant or adjuvant setting will be eligible provided chemotherapy was completed > 6 months prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) except for Gilbert's syndrome
- Hepatic enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT] ) =< 2.5 times the institutional ULN
- Serum sodium (Na), potassium (K+), magnesium (Mg+), phosphate and calcium (Ca+) > lower limit of normal (LLN)
- Serum creatinine =< 1.5 time the institutional ULN
- Hemoglobin (Hb) >= 9
- Platelets >= 100,000
- Absolute neutrophil count (ANC) >= 1000
- Ability to take oral medication (study medications must be swallowed whole)
- Men with fathering potential must agree to use contraception throughout study treatment; acceptable methods include: condoms, sponge, intrauterine device (IUD), oral contraceptives
- Concomitant medications * Patient agrees to discontinue St. Johns wort while receiving dasatinib therapy (discontinue St. Johns wort at least 5 days before starting dasatinib)
Exclusion Criteria:
Known hepatitis B or C or human immunodeficiency virus (HIV), regardless of viral load
* Testing for the purposes of enrollment is not mandatory, however a documented history of these infections will be exclusionary due to concerns for drug-drug interactions with antivirals and potential for increased risk of liver toxicity
- Radiation for palliation of bony metastases within the preceding 2 weeks
Prior chemotherapy for metastatic castration-resistant prostate cancer (CRPC)
* Immune therapy with sipuleucel-T is allowed, provided the last infusion was >= 28 days prior to study therapy and there has been at least one documented PSA value rising after completion of sipuleucel-T therapy or progression of disease on imaging after sipuleucel-T
Malignancy (aside from prostate cancer) which required radiotherapy or systemic treatment within the past 5 years
- Superficial bladder cancer treated with intravesical therapy and currently in remission will not be an exclusion
- Skin cancers will not be an exclusion, except for melanoma with a thickness > 1 mm
Concurrent medical condition which may increase the risk of toxicity, including:
- Pleural or pericardial effusion of any grade at the time of study entry
Cardiac symptoms; any of the following should be considered for exclusion: ** Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months)
- Diagnosed congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) ** Prolonged QTc/f interval on pre-entry electrocardiogram (> 450 msec)
- Hypokalemia or hypomagnesemia if it cannot be corrected prior to abiraterone administration
History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
- Ongoing or recent (=< 3 months) significant gastrointestinal bleeding
Prohibited treatments and/or therapies
- Should not be on any additional anti-cancer therapy except for luteinizing hormone-releasing hormone (LHRH) agonist/antagonist; specifically excluded medications include ketoconazole, estrogens, and anti-androgens
Category I drugs that are generally accepted to have a risk of causing Torsades de pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
- Quinidine, procainamide, disopyramide
- Amiodarone, sotalol, ibutilide, dofetilide
- Erythromycin, clarithromycin
- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: Arm A (abiraterone acetate, prednisone)
Abiraterone acetate 1000 mg PO QD and Prednisone 5 mg PO BID on days 1-28.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Vzhledem k PO
Ostatní jména:
Vzhledem k PO
Ostatní jména:
|
Experimentální: Arm B (abiraterone acetate, prednisone, dasatinib)
Abiraterone acetate 1000 mg PO QD, Prednisone 5 mg PO BID, and dasatinib 100 mg PO QD on days 1-28.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Vzhledem k PO
Ostatní jména:
Vzhledem k PO
Ostatní jména:
Vzhledem k PO
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Progression-free survival (PFS)
Časové okno: From the start of abiraterone acetate until first evidence of disease progression or until death from any cause, whichever occurs first, assessed up to 3 years
|
PFS defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
A one-sided, 0.05-level log rank test will be used to compare the two arms in terms of PFS.
PFS will be estimated using the product-limit method of Kaplan and Meier.
|
From the start of abiraterone acetate until first evidence of disease progression or until death from any cause, whichever occurs first, assessed up to 3 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Overall response
Časové okno: Up to 3 years
|
Overall response defined as the percent of subjects whose best response is a complete response or partial response based on RECIST version 1.1.
Exact 95% confidence intervals will be calculated for this estimate.
|
Up to 3 years
|
PSA change response according to PSA Working Group Criteria 2
Časové okno: Baseline and 12 weeks
|
PSA changes will be summarized for each arm also using waterfall plots as well as standard descriptive statistics.
|
Baseline and 12 weeks
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Overall survival
Časové okno: From start of abiraterone acetate and/or dasatinib treatment until death due to any cause or time the patient was last known to be alive, assessed up to 3 years
|
Estimated using the product-limit method of Kaplan and Meier.
The probability of remaining alive at 6, 12, 18 and 24 months, with the associated Greenwood's standard errors, will be summarized.
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From start of abiraterone acetate and/or dasatinib treatment until death due to any cause or time the patient was last known to be alive, assessed up to 3 years
|
Intent-to-treat analysis
Časové okno: Up to 3 years
|
Up to 3 years
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Tanya Dorff, University of Southern California
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Novotvary
- Urogenitální novotvary
- Novotvary podle místa
- Genitální novotvary, muži
- Onemocnění prostaty
- Novotvary prostaty
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Protizánětlivé látky
- Antineoplastická činidla
- Glukokortikoidy
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Antineoplastická činidla, Hormonální
- Inhibitory proteinkinázy
- Inhibitory enzymu cytochromu P-450
- Antagonisté hormonů
- Inhibitory syntézy steroidů
- Prednison
- Abirateron acetát
- Dasatinib
Další identifikační čísla studie
- 4P-12-1
- NCI-2012-01485 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
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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