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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002652-17 | EudraCT Number |
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This is a first-in-man, phase I clinical research study with BKM120, a potent and highly specific oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor. The study consists of a dose escalation part followed by a MTD expansion part.
Once the MTD has been defined, the MTD expansion part will be opened for enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BKM120 | Experimental | Dose escalation followed by dose expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BKM120 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of BKM120 | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of BKM120 | throughout the study | |
| Pharmacokinetics of BKM120 | throughout the study | |
| Changes in tumor metabolic activity |
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Inclusion Criteria:
All patients:
MTD Expansion part:
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 |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4) | Nashville | Tennessee | 37203 | United States | ||
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| Label | URL |
|---|---|
| Results for CBKM120X2101 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C571178 | NVP-BKM120 |
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| throughout the study |
| Pharmacodynamics of BKM120 | throughout the study |
| Clinical tumor response in patients with tumors that show PI3K pathway activation | throughout the study |
| Novartis Investigative Site |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| Novartis Investigative Site | Rotterdam | 3015 CE | Netherlands |
| Novartis Investigative Site | Rotterdam | 3075 EA | Netherlands |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| D017437 |
| Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |