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The primary objective of this trial is to explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours.
Secondary objective is collection of preliminary data on anti-tumour efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 853520 | Experimental | BI 853520 once daily in a dose escalation schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 853520 | Drug | BI 853520 once daily in a dose escalation schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the MTD. It will be defined by the occurrence of dose-limiting toxicities (DLT) during the first treatment cycle of each patient | After the first 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Every 8 weeks until end of study participation, assessed up to 12 months | |
| Disease control rate | Every 8 weeks until end of study participation, assessed up to 12 months | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1300.15.81001 Boehringer Ingelheim Investigational Site | Kashiwa-shi, Chiba | Japan | ||||
| 1300.15.88601 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30725402 | Derived | Doi T, Yang JC, Shitara K, Naito Y, Cheng AL, Sarashina A, Pronk LC, Takeuchi Y, Lin CC. Phase I Study of the Focal Adhesion Kinase Inhibitor BI 853520 in Japanese and Taiwanese Patients with Advanced or Metastatic Solid Tumors. Target Oncol. 2019 Feb;14(1):57-65. doi: 10.1007/s11523-019-00620-0. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Duration of disease control |
| Every 8 weeks until end of study participation, assessed up to 12 months |
| Tumour shrinkage (in millimetre) defined as the difference between the minimum post-baseline sum of longest diameters of target lesions and the baseline sum of longest diameters of the same set of target lesions | Every 8 weeks until end of study participation, assessed up to 12 months |
| Taipei |
| Taiwan |