Recent Updates
Recently added Catalysts

BAY1143572

Phase 1

Neoplasms | Small molecule | Oncology |Bayer AG|Last Updated: Oct 20, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

BAY1143572 · 1 trial · 1 indication

Phase 1 1
NCT01938638Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced CancerNeoplasms
COMPLETED80 Analytics
PHASE1COMPLETED
Open Label Phase I Dose Escalation Study With BAY1143572 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 (MTD) of BAY1143572
Up to 1 year

In Part A: Maximum tolerated dose (MTD) of BAY1143572 In Part B; Maximum tolerated dose ( MTD) with G-CSF of BAY114357 The MTD is defined as the highest dose that can be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during cycle 1.

Secondary Endpoints

Maximum total drug concentration (Cmax)
Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)
Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to infinity (AUC)
Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY1143572 [continuous]EXPERIMENTALBAY1143572 will be administered from cycle 1, day 1 (C1D1) onwards once daily continuously
BAY1143572 [on/off]EXPERIMENTALBAY1143572 will be administered from C1D1 in a 3 days on/4 days off schedule

Interventions

NameTypeDescription
BAY1143572DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Male or female subjects aged \>/=21 years * Dose escalation phase: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors and malignant lymphomas) who were refractory to or had exhausted all available therapies. Subjects had to have evaluab...

Countries:United StatesSingaporeSouth KoreaTaiwan
Unlock Eligibility Criteria

Frequently asked questions about BAY1143572

What is BAY1143572 used for?

BAY1143572 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 in Phase 1 clinical development for oncology indications.

Who makes BAY1143572?

BAY1143572 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY.

What phase is BAY1143572 in?

BAY1143572 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy.

What clinical trials is BAY1143572 in?

BAY1143572 has been studied in one clinical trial, NCT01938638, titled "Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer." This Phase 1 trial enrolled 80 patients with neoplasms and has been completed.

Is BAY1143572 the same as any other drug?

BAY1143572 is the primary identifier for this investigational compound. No alternative names have been reported for this drug in clinical trial records.