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BAY1082439

Phase 1

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

BAY1082439 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2012

BAY1082439 target and mechanism

Molecular targetPIK3CA, PIK3CB
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

BAY1082439 clinical trials

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?

BAY1082439 is an investigational small molecule developed by Bayer AG for the treatment of neoplasms, or advanced cancers. It is a Phase 1 oncology candidate and has not been approved for any indication. Bayer AG trades over the counter under the ticker BAYRY.

What is BAY1082439 used for?

BAY1082439 is being studied for use in patients with neoplasms, meaning advanced or solid cancers. Its only recorded clinical study enrolled adults with advanced cancer. The drug remains investigational and is not approved for treating cancer or any other condition.

What does BAY1082439 target?

BAY1082439 targets PIK3CA and PIK3CB, two isoforms of phosphoinositide 3-kinase. It is classified as an inhibitor of these targets, which are part of the PI3K signaling pathway frequently altered in cancer. Targeting both isoforms distinguishes it from agents selective for a single PI3K isoform.

Who is developing BAY1082439?

BAY1082439 is developed by Bayer AG, the German pharmaceutical and life sciences company. Bayer's ordinary shares trade on the Frankfurt exchange, and its American depositary receipts trade over the counter in the United States under the ticker BAYRY.

What phase is BAY1082439 in?

BAY1082439 is in Phase 1 clinical development. Its single recorded trial was an open label Phase 1 study in patients with advanced cancer, and that study is now completed. The drug is investigational and has not received FDA approval.

What clinical trials is BAY1082439 in?

BAY1082439 has been evaluated in one clinical trial, NCT01728311, titled an open label study of BAY1082439 in patients with advanced cancer. That Phase 1 trial enrolled 60 patients across Singapore, South Korea, and Taiwan and is completed. No active trials are currently recorded.