Clinical trial · Interventional
Japanese BAY1000394 Monotherapy Phase I Study
An Open-label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics of BAY1000394 Given in a 3 Days on / 4 Days Off Schedule in Japanese Subjects With Advanced Malignancies
NCT02047890CI-TRIAL-00039189completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, non-randomized, dose-escalating Phase I study to evaluate the safety, tolerability, pharmacokinetics of BAY1000394 given in a 3 days on / 4 days off schedule in Japanese subjects with advanced malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY1000394 (2.5mg) | Drug | — | UNRESOLVED |
| BAY1000394 (5mg) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BAY1000394
- description
- Approximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).
- interventionNames
- Drug: BAY1000394 (2.5mg)
- Drug: BAY1000394 (5mg)
Primary outcomes (18)
- measure
- Number of participants with adverse events as a measure of safety and tolerability
- timeFrame
- 6 months
- measure
- Number of participants with abnormal lab parameters based on descriptive statistics
- timeFrame
- 6 months
- measure
- Maximum observed drug concentration (Cmax) for BAY1000394 and its metabolite M-1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Japanese male or female subjects aged ≥20 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Life expectancy of at least 12 weeks * Subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable * At least 1 tumor lesion evaluable by computer tomography (CT) or scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Adequate bone marrow, liver, and renal functions Exclusion Criteria: * Anticancer chemotherapy or immunotherapy within 4 weeks of study entry. Mitomycin C or nitrosoureas should not be given within 6 weeks of study entry. * Radiotherapy to target lesions within 3 weeks prior to the first dose of study drug. * Use of biological response modifiers, such as granulocyte colony-stimulating factor (G-CSF), within 3 weeks prior to the first dose of study drug. * Symptomatic metastatic brain or meningeal tumors. * Investigational drug treatment outside of this study during or within 4 weeks prior to study entry. * Blood pressure \<100/60 mmHg or pulse \>100 BPM
References
Publications (0)
Data not yet available
No reference posted for this study.