An open-label randomized two-arm Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and maximum tolerated dose of oral BAY 1217389 in combination with weekly intravenous paclitaxel given in an intermittent dosing schedule in subjects with advanced malignancies

An open-label randomized two-arm Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics, and maximum tolerated dose of oral BAY 1217389 in combination with weekly intravenous paclitaxel given in an intermittent dosing schedule in subjects with advanced malignancies - Phase I study of oral BAY 1217389 in combination with IV paclitaxel

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45121

Enrollment

Registered

2015-04-13

Start date

2015-04-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced malignancies advances cancer (solid tumors)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (selected): (1) Male or female subjects aged > or = 18 years (2) Study population For the dose-escalation cohorts: Subjects with 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 judgement of the investigator, experimental treatment is clinically acceptable. For the expansion cohort: Subjects with advanced, histologically or cytologically confirmed TNBC, relapsed on a paclitaxel-containing regimen within 12 months prior to enrollment and refractory to any standard therapy, have no standard therapy available. Other malignancies where paclitaxel is part of the standard of care may be considered upon agreement of the investigator and the sponsor. (3) Subjects must have evaluable or measurable disease. (4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (5) Life expectancy of at least 12 weeks (6) Adequate bone marrow, liver, and renal functions

Exclusion criteria

Exclusion criteria: Exclusion criteria (selected) (1) Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study (2) Evidence of peripheral neuropathy of Grade >2 (3) 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) (4) Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg, despite optimal medical management (5) Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C (6) History of human immunodeficiency virus, hepatitis B, or hepatitis C infection (7) Active clinically serious infections of Grade >2 (8) Central nervous system metastases

Design outcomes

Primary

Measure	Time frame
The primary study outcome is the MTD. The MTD is defined as the highest dose that can be given such that the DLT rate of the combination treatment is not more than 10% higher than the cumulative DLT rate of the standard single-agent treatment across all previous and the current cohort.	—

Countries

Netherlands

Outcome results