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BAY1251152

Phase 1

Hematologic Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Sep 19, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

BAY1251152 · 1 trial · 1 indication

Phase 1 1
NCT02745743Phase I Trial of BAY1251152 for Advanced Blood CancersHematologic Neoplasms
COMPLETED21 Analytics
PHASE1COMPLETED
Phase I Trial of BAY1251152 for Advanced Blood Cancers
Hematologic NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose(MTD)
21 days

To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms

Recommended Phase 2 dose (RP2D)
Up to 30 months

To determine the RP2D of BAY1251152 based on safety, tolerability, pharmacokinetic, and pharmacodynamic data in subjects with advanced hematological neoplasms

Number of adverse events (AE)
Up to 30 months

For assessment of the safety (ECG, vital signs, clinical significant abnormal laboratory results… etc.)and tolerability of BAY 1251152 in subjects with advanced hematological neoplasms

Pharmacokinetics (PK) is determined by maximum concentration (Cmax)
21 days
Pharmacokinetics (PK) is determined by Area Under concentration versus time Curve (AUC)
21 days

Secondary Endpoints

Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from
Up to 30 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALBiomarker-enriched advanced hematological neoplasms
Arm 2EXPERIMENTALOther selected advanced hematological neoplasms

Interventions

NameTypeDescription
BAY1251152DRUGWeekly infusion of BAY1251152 in 21-day cycles.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Male or female patients aged ≥18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and Life expectancy of at least 12 weeks * Patients are able and willing to provide bone marrow biopsies/aspirates as requested by the protocol * Patients with confi...

Countries:United StatesGermanySpainUnited Kingdom
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Frequently asked questions about BAY1251152

What is BAY1251152 used for?

BAY1251152 is an investigational small molecule being developed for the treatment of hematologic neoplasms, which are cancers of the blood and bone marrow. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes BAY1251152?

BAY1251152 is being developed by Bayer AG, a multinational pharmaceutical company headquartered in Germany. Bayer's stock is traded on the over-the-counter market under the ticker symbol BAYRY.

What phase is BAY1251152 in?

BAY1251152 is in Phase 1 clinical development. A Phase 1 trial for advanced blood cancers has been completed, but the drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is BAY1251152 in?

BAY1251152 has one completed clinical trial, identified as NCT02745743, titled 'Phase I Trial of BAY1251152 for Advanced Blood Cancers.' This trial enrolled 21 participants with hematologic neoplasms and was conducted in the United States, Germany, Spain, and the United Kingdom.

Is BAY1251152 FDA approved?

BAY1251152 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it has not received marketing authorization from the U.S. Food and Drug Administration or any other regulatory agency.