Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel

Completed · Phase 1

Conditions studied: Medical Oncology

In brief

Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY1217389 given in combination with intravenous (IV) paclitaxel using an intermittent dosing schedule (2 days on / 5 days off) in subjects with advanced malignancies.

Key facts

Study ID

NCT02366949

Run by

Bayer

People needed

75

Starts

2015-02-27

Expected to finish

2019-04-18

Last updated by the study team

2020-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged >/= 18 years.
• 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
• For the expansion cohort: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer (TNBC), 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 acceptable.
• 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.

You may not qualify if…

• 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).
• 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), hepatitis B or hepatitis C infection.

Where it is running

• Study site — Santa Monica, California, United States
• Study site — Denver, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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