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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022331-11 | EudraCT Number |
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The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEZ235 + paclitaxel | Experimental |
| |
| BKM120 + paclitaxel | Experimental |
| |
| BEZ235 + paclitaxel + trastuzumab | Experimental |
| |
| BKM120 + paclitaxel + trastuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEZ235 + paclitaxel | Drug |
| ||
| BKM120 + paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose limiting toxicities during the first cycle of treatment. | First treatment cycle (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of safety events during the whole treatment period (until progression of disease). | From start of treatment until disease progression | |
| pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22. | First treatment cycle (4 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Brussels | 1000 | Belgium | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CBEZ235A2118 can be found on the Novartis Clinical Trials website | View source |
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|
| BEZ235 + paclitaxel + trastuzumab | Drug |
|
| BKM120 + paclitaxel + trastuzumab | Drug |
|
| Treatment efficacy (response to treatment according to RECIST criteria) | From start of treatment until disease progression |
| Impact of treatment on biomarkers of Pi3 Kinase pathway (analyses of skin biopsies, circulating markers) | From start of treatment until disease progression |
| Brussels |
| 1200 |
| Belgium |
| Novartis Investigative Site | Wilrijk | 2610 | Belgium |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Amsterdam | 1066 CX | Netherlands |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Chur | 7000 | Switzerland |
| Novartis Investigative Site | Sankt Gallen | 9007 | Switzerland |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C531198 | dactolisib |
| D017239 | Paclitaxel |
| C571178 | NVP-BKM120 |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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