Clinical trial · Interventional
BAY86-9766 Plus Gemcitabine Phase I Study in Asian
A Multi-center, Phase Ib Study of MEK (Mitogen Activated Protein Kinase/ERK Kinase) Inhibitor BAY86-9766 Plus Gemcitabine in Asian Patients With Advanced or Refractory Solid Tumors
- 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, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766. Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.
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 |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Refametinib (BAY86-9766) | Drug | Refametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Refametinib (BAY86-9766)+ Gemcitabine
- description
- Single dose of BAY86-9766 on Cycle 1 Day -17; twice daily dosing every day starting on day -14, start dose 50mg bid ( 30mg or 20mg are possible based on adverse events need) in addition with Gemcitabine intravenous on day 1,8 and 15 1000mg/m2
- interventionNames
- Drug: Refametinib (BAY86-9766)
- Drug: Gemcitabine
Primary outcomes (5)
- measure
- Plasma concentration of BAY86-9766
- timeFrame
- Multiple time points up to 6 day
- measure
- Plasma concentration of M17 and M11
- timeFrame
- Multiple time points up to 6 day
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients \>/= 18 years of age, with histologically or cytologically documented advanced or refractory solid tumors not amenable to standard therapy * Patients must have at least one measurable or evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Patients must have a life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) \</=1. Exclusion Criteria: * History of cardiac disease * Active clinically serious infections \> Common Terminology Criteria for Adverse Events (CTCAE) grade 2 * Known human immunodeficiency virus (HIV) infection * Uncontrolled seizure disorder * Undergoing renal dialysis * Known bleeding diathesis * History of organ allograft * Pregnant or breast feeding women
References
Publications (0)
Data not yet available