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BAY1082439

Phase 1

Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Jan 30, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

BAY1082439 · 1 trial · 1 indication

Phase 1 1
NCT01728311Open Label Study of BAY1082439 in Patients With Advanced CancerNeoplasms
COMPLETED60 Analytics
PHASE1COMPLETED
Open Label Study of BAY1082439 in Patients With Advanced Cancer
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events as a measure of safety and tolerability
Up to 2 years
Maximum tolerated dose of BAY1082439
Up to 1 year
Maximum observed plasma concentration (Cmax) of BAY1082439 after a single dose
Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Time to Cmax (tmax) of BAY1082439 after a single dose
Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2
Area under the plasma concentration-time curve (AUC[0-t]) of BAY1082439 after a single dose
Serial PK samples will be selected during cycle 1 day 1 (pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose) and sparse samples during the rest of the cycle as well as in cycle 2

Secondary Endpoints

Area under the concentration-time curve over the dosing interval (AUC[0-tau])
PK parameters following single and repeat-dose administration in cycle 1
Maximum observed concentration (Cmax)
PK parameters following single and repeat-dose administration in cycle 1
Time of occurrence of Cmax (tmax)
PK parameters following single and repeat-dose administration in cycle 1
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
BAY1082439DRUGBAY1082439 will be given orally once daily with a 21 days cycle. Dose will be started from 15mg.
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the inv...

Countries:SingaporeSouth KoreaTaiwan
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Frequently asked questions about BAY1082439

What is BAY1082439 used for?

BAY1082439 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in clinical development for oncology indications, specifically in patients with advanced cancer.

Who makes BAY1082439?

BAY1082439 is being developed by Bayer AG, a multinational pharmaceutical company headquartered in Germany. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.

What phase is BAY1082439 in?

BAY1082439 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The drug is being studied in an early-stage clinical trial to evaluate its safety and tolerability in patients with advanced cancer.

What clinical trials is BAY1082439 in?

BAY1082439 has been studied in one clinical trial with the identifier NCT01728311, titled 'Open Label Study of BAY1082439 in Patients With Advanced Cancer.' This Phase 1 trial enrolled 60 participants and was conducted in Singapore, South Korea, and Taiwan. The trial has been completed.

How does BAY1082439 work?

The specific molecular target of BAY1082439 has not been disclosed in available information. As a small molecule, it is designed to interact with cellular components to exert its therapeutic effect, but the exact mechanism of action is not publicly detailed.