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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003441-42 | EudraCT Number |
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This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PQR309 | Experimental | Different dose evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PQR309 | Drug | Dosing will be orally, once a day for the duration of the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) | In average 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To determine overall safety | Incidence of SAEs, incidence and severity of all AEs, changes of vital signs, physical examinations, body weight, changes of routine laboratory assessments. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Wicki, Dr. | University Hospital, Basel, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29660598 | Derived | Wicki A, Brown N, Xyrafas A, Bize V, Hawle H, Berardi S, Cmiljanovic N, Cmiljanovic V, Stumm M, Dimitrijevic S, Herrmann R, Pretre V, Ritschard R, Tzankov A, Hess V, Childs A, Hierro C, Rodon J, Hess D, Joerger M, von Moos R, Sessa C, Kristeleit R. First-in human, phase 1, dose-escalation pharmacokinetic and pharmacodynamic study of the oral dual PI3K and mTORC1/2 inhibitor PQR309 in patients with advanced solid tumors (SAKK 67/13). Eur J Cancer. 2018 Jun;96:6-16. doi: 10.1016/j.ejca.2018.03.012. Epub 2018 Apr 13. |
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