Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel

Stopped early · Phase 1

Conditions studied: Medical Oncology

In brief

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.

Key facts

Study ID

NCT02138812

Run by

Bayer

People needed

69

Starts

2014-05-09

Expected to finish

2017-10-02

Last updated by the study team

2018-10-12

Who can join

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

You may qualify if…

• 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

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)
• 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.

Where it is running

• Study site — Santa Monica, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Nashville, Tennessee, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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