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BAY1125976

Phase 1

Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Dec 28, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

BAY1125976 · 1 trial · 1 indication

Phase 1 1
NCT01915576Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in PatientsNeoplasms
COMPLETED79 Analytics
PHASE1COMPLETED
Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients
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 (MTD) of BAY1125976
up to 2 years
Area under the plasma concentration vs time curve from zero to infinity after single (first) dose
at pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

Secondary Endpoints

Food effect assessment
up to 2 years
Tumor response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) definitions
up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY1125976 [once daily, dose-esc.]EXPERIMENTALOral administration once daily. Starting dose is 10 mg and will be escalated depending on any dose-limiting toxicities
BAY1125976 [twice daily, dose-esc.]EXPERIMENTALOral administration twice daily. Starting dose is 40mg twice daily and will be escalated depending on any dose-limiting toxicities
BAY1125976 [MTD]EXPERIMENTALOral administration of the defined MTD which shows optimal safety, PK profile, PD target inhibition and preliminary efficacy (once daily or twice daily) in different patient groups

Interventions

NameTypeDescription
BAY1125976DRUGOral administration once daily. Starting dose is 10 mg and will be escalated depending on any dose-limiting toxicities
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * For dose escalation cohorts: Subjects with advanced, histologically or cytologically confirmed solid tumors are eligible. Subjects' tumors (all comers) must be refractory to standard treatment with no standard therapy available, or subjects actively refuse any treatment, which...

Countries:United StatesFranceGermanySwitzerland
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Frequently asked questions about BAY1125976

What is BAY1125976 used for?

BAY1125976 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 being developed as a potential oncology therapy, though it is still in clinical development and not yet approved for any use.

What does BAY1125976 target?

BAY1125976 is an allosteric AKT 1/2 inhibitor. It targets the AKT1 and AKT2 proteins, which are part of the PI3K/AKT signaling pathway involved in cell growth and survival. By inhibiting these targets, the drug aims to interfere with cancer cell proliferation.

Who makes BAY1125976?

BAY1125976 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 BAY1125976 in?

BAY1125976 is in Phase 1 clinical development. It has completed a Phase 1 dose escalation study, but it remains investigational and has not received FDA approval. The drug is still in the early stages of clinical testing.

What clinical trials is BAY1125976 in?

BAY1125976 has been studied in one clinical trial, NCT01915576, a Phase 1 dose escalation study in patients with neoplasms. This trial enrolled 79 participants and was conducted in the United States, France, Germany, and Switzerland. The trial has been completed.

Is BAY1125976 the same as any other drug?

No alternative names for BAY1125976 have been disclosed. The drug is identified by its compound code BAY1125976 in clinical and research settings.