Clinical trial · Interventional
Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel
An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY1161909 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
NCT02138812CI-TRIAL-00035256terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): As another Mps1 inhibitor was being developed in parallel, the strategic decision was to move forward with the development of the follow up compound only.
Summary
Brief summary (as posted)
Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) of BAY1161909 in combination with paclitaxel in 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 |
|---|---|---|---|
| Medical Oncology | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY1161909 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BAY1161909 + Paclitaxel
- description
- Participants received oral doses of BAY1161909 starting from 0.75 mg twice daily, from C1D1 onwards in a 2 days on/5 days off dosing schedule as single agent treatment in Cycle 1 (14 days), and from C2D8 onwards in a 2 days on/5 days off dosing schedule in combination with weekly intravenous paclitaxel on D1, D8, and D15 of the 28-day cycles. For single-dose Pharmacokinetic (PK) cohort: in Cycle 1, participants received a single oral dose of 6 mg BAY1161909 on C1D1 with no BAY1161909 dosing for the remainder of Cycle 1.
- interventionNames
- Drug: BAY1161909
- Drug: Paclitaxel
Primary outcomes (7)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Up to 2 years
- description
- MTD is defined as the highest dose of oral BAY1161909 (administered in combination with or without IV paclitaxel) that can be given such that not more than 30% of the subjects experience a dose-limiting toxicity (DLT) during Cycles 1 and 2. The safety profile of oral BAY1161909 will first be determined in combination with 75 mg/m\^2 IV paclitaxel \[MTD (75)\]. Starting in \>Cohort 7 (12 mg 2 times daily \[BID\] BAY1161909) the MTD of oral BAY1161909 will then be refined for the combination with 90 mg/m\^2 IV paclitaxel \[MTD (90)\].
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects aged =/\> 18 years * Subjects with advanced, histologically or cytologically confirmed advanced malignancies (solid tumors), refractory to any standard therapy, have no standard therapy available, or subjects actively refused any standard treatment and / or if, in the judgment of the investigator, experimental treatment is clinically and ethically acceptable. * For the expansion cohort: women with histologically or cytologically confirmed triple negative breast cancer (TNBC) * Subjects must have evaluable or measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Life expectancy of at least 12 weeks * Adequate bone marrow, liver, and renal functions Exclusion Criteria: * Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study * Evidence of peripheral neuropathy of Grade \> 2 * History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class \> II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted) * Prior treatment with more than 3 lines of cytostatic therapies for metastatic disease unless specifically agreed between investigator and sponsor. Subjects with a history of any prior Grade =/\> 3 toxicity associated with taxane treatment will be excluded. * Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg, despite optimal medical management * Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C * History of human immunodeficiency virus (HIV) infection.
References
Publications (0)
Data not yet available
No reference posted for this study.