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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002250-23 | EudraCT Number |
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This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.
A dose-escalation part will first determine the maximum tolerated dose (MTD) and/or recomended dose for expansion (RDE) of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation: BEZ235 + Zytiga® | Experimental | 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 |
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| Dose escalation: BKM120 + Zytiga® | Experimental | 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 |
|
| Dose expansion: BEZ235 + Zytiga® | Experimental | 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 |
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| Dose Expansion: BKM120 + Zytiga® | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEZ235 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting toxicities (DLTs) | Dose escalation part: Determine MTD and /or RDE of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of DLTs in cycle 1 | from days 1-35 in BEZ235/abiraterone acetate arm and from days 1-28 in BKM120/abiraterone acetate arm |
| Prostate specific antigen (PSA) decline ≥ 30% | Dose expansion part: Assess anti-tumor activity of the combinations (abiraterone acetate + BEZ235 and abiraterone acetate + BKM120) in castration-resistant prostate cancer patients with abiraterone acetate failure as on treatment PSA progression according to prostate cancer working group criteria 2 (PCWG2) by assessing PSA decline ≥ 30% at Week 12 or later. | At week 12 or later after treatment discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with at least one adverse event | Treatment start until 30 days after the last dose | |
| radiological Progression Free Survival as per RECIST 1.1 and PCWG2 | Every 12 weeks until disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center SC | Los Angeles | California | 90048 | United States | ||
| Hackensack University Medical Center Hackensack Univ |
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| Label | URL |
|---|---|
| Results for CBEZ235D2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| BKM120 | Drug | 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. |
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| BEZ235 | Drug | 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. |
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| BKM120 | Drug | 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. |
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| radiological Response Rate according to RECIST 1.1 | Every 12 weeks until disease progression |
| Overall Survival | From treatment start until 75% of deaths from any cause have occurred |
| Number and percentage of patients with laboratory abnormalities | Treatment start until 30 days after the last dose |
| Changes in ECG (electrocardiogram) | Treatment start until 30 days after the last dose |
| Changes in vital signs | Treatment start until 30 days after the last dose |
| Changes in mood scales | Treatment start until 30 days after the last dose |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Novartis Investigative Site | Brussels | BE-B-1200 | Belgium |
| Novartis Investigative Site | Wilrijk | 2610 | Belgium |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Novartis Investigative Site | Marseille | 13273 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Barcelona | Catalonia | 08036 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| C531198 | dactolisib |
| C571178 | NVP-BKM120 |
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