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

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
Status
LocationsStatus
Locations

Investigative Site

San Antonio, United States, 78229-3307

Status
Completed
 
Locations

Investigative Site

Santa Monica, United States, 90403

Status
Completed
 
Locations

Investigative Site

Denver, United States, 80262

Status
Completed
 
Locations

Investigative Site

Hackensack, United States, 07601-1991

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77030

Status
Completed
 
Locations

Investigative Site

ROTTERDAM, Netherlands, 3075 EA

Status
Completed
 
Locations

Investigative Site

New Haven, United States, 06520

Status
Completed
 

Trial Design