Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients
NCT ID: NCT01634061
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2012-09-30
2015-07-31
Brief Summary
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Detailed Description
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Subsequently, the MTD and/or RDE of each combination will be investigated in two expansion treatment groups of CRPC patients who have failed abiraterone acetate therapy.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose escalation: BEZ235 + Zytiga®
BEZ235 oral twice daily: 200 mg, 300 mg, and 400 mg dose levels to be tested in the dose escalation part in combination with abiraterone acetate Zytiga® abiraterone acetate oral once daily: 1000 mg taken with low dose prednisone as per the label
BEZ235
BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
Dose escalation: BKM120 + Zytiga®
BKM120 oral once daily: 60 mg, 80 mg and 100 mg dose levels to be tested in the dose escalation part in combination with abiraterone acetate Zytiga® abiraterone acetate oral once daily: 1000 mg taken with low dose prednisone as per the label
BKM120
BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
Dose expansion: BEZ235 + Zytiga®
BEZ235 oral twice daily: 200 mg, 300 mg, and 400 mg dose levels to be tested in the dose escalation part in combination with abiraterone acetate
Zytiga® abiraterone acetate oral once daily: 1000 mg taken with low dose prednisone as per the label
BEZ235
BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
Dose Expansion: BKM120 + Zytiga®
BKM120 oral once daily: 60 mg, 80 mg and 100 mg dose levels to be tested in the dose escalation part in combination with abiraterone acetate Zytiga® abiraterone acetate oral once daily: 1000 mg taken with low dose prednisone as per the label
BKM120
BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
Interventions
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BEZ235
BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
BKM120
BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
BEZ235
BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
BKM120
BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group Performance Status ≤ 2
* Patient must have a castrate level of testosterone (\<= 50 ng/dL or 1.7 nmol/L). ( Castrate status must be maintained by continued GnRH analogues unless patient has undergone surgical orchiectomy).
* Histologically or cytologically confirmed diagnosis of advanced or metastatic prostate cancer.
* Advanced or metastatic castration-resistant prostate cancer progression after abiraterone acetate failure
* Patients should have no more than 2 lines of prior chemotherapies including cytotoxic agents
* Discontinuation of all anti-androgen, anti-neoplastic or investigational treatment \>= 4 weeks (6 weeks for bicalutamide).
Exclusion Criteria
* Patient has active uncontrolled or symptomatic CNS metastases
* Inadequately controlled hypertension (e.g. systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg)
* Patient has a QTcF \> 480 msec on the screening ECG (using the QTcF formula), has a short/long QT syndrome, or history of QT prolongation/Torsades de Pointes
* Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs
* Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others)
* Patients who experienced dose reductions and/or treatment interruptions due to abiraterone acetate related toxicities (i.e. serious AEs, AEs, liver toxicities during abiraterone acetate treatment
18 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Cedars Sinai Medical Center SC
Los Angeles, California, United States
Hackensack University Medical Center Hackensack Univ
Hackensack, New Jersey, United States
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Wilrijk, , Belgium
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Sutton, , United Kingdom
Countries
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Related Links
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Results for CBEZ235D2101 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2012-002250-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBEZ235D2101
Identifier Type: -
Identifier Source: org_study_id