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The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents.
The purpose of this study Part B is:
Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1143572 [continuous] | Experimental | BAY1143572 will be administered from cycle 1, day 1 (C1D1) onwards once daily continuously |
|
| BAY1143572 [on/off] | Experimental | BAY1143572 will be administered from C1D1 in a 3 days on/4 days off schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1143572 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to 2 years | |
| Maximum tolerated dose (MTD) of BAY1143572 | In Part A: Maximum tolerated dose (MTD) of BAY1143572 In Part B; Maximum tolerated dose ( MTD) with G-CSF of BAY114357 The MTD is defined as the highest dose that can be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during cycle 1. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum total drug concentration (Cmax) | Cycle 1, Day 1 and Day 15 (each cycle is 28 days) | |
| Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24) | Cycle 1, Day 1 and Day 15 (each cycle is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayetteville | Arkansas | 72703 | United States | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000625640 | atuveciclib |
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| Area under the plasma concentration-time curve from time zero to infinity (AUC) | Cycle 1, Day 1 and Day 15 (each cycle is 28 days) |
| Time of maximum observed concentration (tmax) | Cycle 1, Day 1 and Day 15 (each cycle is 28 days) |
| Tumor response based on RECIST 1.1 or Cheson 2007 criteria | Up to 100 weeks |
| Biomarker evaluation by determination of MYC protein expression and PCNA mRNA | PCNA: proliferating cell nuclear Antigen mRNA: messenger ribonucleic acid | Cycle 1, Day 1, Day 8 and Day 15 (each cycle is 28 days) |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Ann Arbor | Michigan | 48109 | United States |
| Hackensack | New Jersey | 07601 | United States |
| New York | New York | 10032 | United States |
| Charleston | South Carolina | 29425 | United States |
| Singapore | 119228 | Singapore |
| Singapore | 169610 | Singapore |
| Seoul | 05505 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 120-752 | South Korea |
| Taipei | 10002 | Taiwan |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |