Clinical trial · Interventional
Japanese BAY86-9766 Monotherapy Phase I Study
Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors
NCT01179295CI-TRIAL-00028177completedPhase 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 uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY86-9766 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: BAY86-9766
- type
- EXPERIMENTAL
- label
- Arm 2
- interventionNames
- Drug: BAY86-9766
- type
- EXPERIMENTAL
- label
- Arm 3
- interventionNames
- Drug: BAY86-9766
- type
- EXPERIMENTAL
- label
- Arm 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy. * Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, with no current involvement in the central nervous system (CNS) * At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1 * Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1 * Life expectancy of at least 12 weeks Exclusion Criteria: * Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication * Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management * Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C * Inadequate bone marrow, liver and renal function * Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs * Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers
References
Publications (0)
Data not yet available
No reference posted for this study.