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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90033
- USC Norris Comprehensive Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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Gegeven PO
Andere namen:
Gegeven PO
Andere namen:
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Experimenteel: 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.
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Gegeven PO
Andere namen:
Gegeven PO
Andere namen:
Gegeven PO
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Progression-free survival (PFS)
Tijdsspanne: 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
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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.
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall response
Tijdsspanne: Up to 3 years
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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.
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Up to 3 years
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PSA change response according to PSA Working Group Criteria 2
Tijdsspanne: Baseline and 12 weeks
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PSA changes will be summarized for each arm also using waterfall plots as well as standard descriptive statistics.
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Baseline and 12 weeks
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Overall survival
Tijdsspanne: 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
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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
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Intent-to-treat analysis
Tijdsspanne: Up to 3 years
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Up to 3 years
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Tanya Dorff, University of Southern California
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Urogenitale neoplasmata
- Neoplasmata per site
- Genitale neoplasmata, mannelijk
- Prostaat Ziekten
- Prostaatneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Ontstekingsremmende middelen
- Antineoplastische middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Proteïnekinaseremmers
- Cytochroom P-450 enzymremmers
- Hormoon antagonisten
- Steroïde syntheseremmers
- Prednison
- Abirateronacetaat
- Dasatinib
Andere studie-ID-nummers
- 4P-12-1
- NCI-2012-01485 (Register-ID: CTRP (Clinical Trial Reporting Program))
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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