Trial Condition(s):

Medical Oncology

Phase I study of oral BAY 1217389 in combination with intravenous paclitaxel

Bayer Identifier:

17350

ClinicalTrials.gov Identifier:

NCT02366949

EudraCT Number:

2014-004821-41

EU CT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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.
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).
 - 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.

Trial Summary

Enrollment Goal
75
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
BAY1217389
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Locations
Locations

Investigative Site

San Antonio, United States, 78229-3307

Locations

Investigative Site

Santa Monica, United States, 90403

Locations

Investigative Site

Denver, United States, 80262

Locations

Investigative Site

Hackensack, United States, 07601-1991

Locations

Investigative Site

Houston, United States, 77030

Locations

Investigative Site

ROTTERDAM, Netherlands, 3075 EA

Locations

Investigative Site

New Haven, United States, 06520

Trial Design