Study Completed

Medical Oncology

Bayer Identifier:

17350

ClinicalTrials.gov Identifier:

NCT02366949

EudraCT Number:

2014-004821-41

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

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

Trial Dates

February 2015 - April 2019

Phase

Phase 1

Could I Receive a placebo

Products

BAY1217389

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		San Antonio, 78229-3307, United States
Completed		Santa Monica, 90403, United States
Completed		Denver, 80262, United States
Completed		Hackensack, 07601-1991, United States
Completed		Houston, 77030, United States
Completed		ROTTERDAM, 3075 EA, Netherlands
Completed		New Haven, 06520, United States

Primary Outcome

Maximum tolerated dose (MTD)
The MTD is defined as the highest dose that can be given such that the dose-limiting toxicity (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.
Time Frame:
Up to 28 days (Cycle 1)
Safety Issue:
Yes
Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability.
Time Frame:
After the first study drug administration and up to 30 days after the end of treatment with study drug before primary completion analysis of the study, up to 3 years
Safety Issue:
Yes
Maximum observed drug concentration (Cmax) of BAY1217389 in plasma
Time Frame:
From pre-dose up to 96 hours post-dose on C1D-8 and C1D-4; from pre-dose up to 12 hours post-dose on C1D8 and C1D9
Safety Issue:
Yes
Area under the concentration versus time curve from zero to 12 hours (AUC [0-12]) of BAY1217389 in plasma
Time Frame:
From pre-dose up to 12 hours post-dose on C1D-4, C1D8 and C1D9
Safety Issue:
Yes
Area under the concentration versus time curve from zero to 96 hours (AUC [0-96]) of BAY1217389 in plasma
Time Frame:
From pre-dose up to 96 hours post-dose on C1D-4
Maximum observed drug concentration (Cmax) of paclitaxel in plasma
Time Frame:
From pre-dose up to 24 hours post-dose on C1D1 and C1D8
Area under the concentration versus time curve from zero to infinity (AUC) of paclitaxel in plasma
Time Frame:
From pre-dose up to 24 hours post-dose on C1D1 and C1D8

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here to find results for studies related to Bayer products v2.0 dated 2021-03-01, updated again due to format issues