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BAY1000394

Phase 1

Neoplasms | Small molecule | Oncology |Bayer AG|Trials Updated: Jun 24, 2019

BAY1000394 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment22

FDA Designations

No designations recorded

BAY1000394 clinical trials

BAY1000394 · 2 trials · 1 indication

Phase 1 2
NCT02047890Japanese BAY1000394 Monotherapy Phase I StudyNeoplasms
COMPLETED12 Analytics
NCT01335256Clinical Study to Evaluate Safety and Maximum Tolerated Dose of BAY1000394 Given in a 4 Week on / 2 Week Off Schedule in Subjects With Advanced MalignanciesNeoplasms
COMPLETED10 Analytics
PHASE1COMPLETED
Japanese BAY1000394 Monotherapy Phase I Study
Neoplasms
NCT0204789012
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PHASE1COMPLETED
Clinical Study to Evaluate Safety and Maximum Tolerated Dose of BAY1000394 Given in a 4 Week on / 2 Week Off Schedule in Subjects With Advanced Malignancies
Neoplasms
NCT0133525610
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Study Endpoints

Primary Endpoints

Number of participants with adverse events as a measure of safety and tolerability
6 months
Number of participants with abnormal lab parameters based on descriptive statistics
6 months
Maximum observed drug concentration (Cmax) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Cmax divided by dose per body weight (Cmax,norm) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Cmax divided by dose (Cmax/D) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Area under the concentration versus time curve from zero to infinity after single dose (AUC) for BAY1000394 and its metabolite M-1
= Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)
AUC from time 0 to 12 hours after single dose (AUC(0-12) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8 and 12 hours
AUC divided by dose per body weight (AUCnorm) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)
AUCnorm from time 0 to 12 hours after single dose (AUC(0-12),norm) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8 and 12 hours
AUC divided by dose (AUC/D) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose)
Time to reach Cmax (tmax) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Terminal half-life (t½) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 1: 0 (pre dose), 0.5, 1, 2, 4, 6, 8, 12 and 24 hours (Day 2, before morning dose). Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Maximum observed drug concentration after multiple dosing (Cmax,md) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Cmax divided by dose per body weight after multiple dosing (Cmax,norm,md) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Cmax divided by dose (Cmax,md/D) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
AUC from time 0 to 12 hours after multiple dosing (AUC(0-12),md) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
AUCnorm from time 0 to 12 hours after multiple dosing (AUC(0-12),norm,md) for BAY1000394 and its metabolite M-1
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
AUC from time 0 to 12 hours divided by dose after multiple dosing for BAY1000394 and its metabolite M-1
Cycle 1 / Day 10 : 0 (before morning dose), 0.5, 1, 2, 4, 6, 8 and 12 hours (before evening dose)
Number of subjects with Adverse Events as a measure safety
Up to 3 years or longer if indicated
Maximum tolerated dose: Measured by adverse event profile
Up to 3 years or longer if indicated

Secondary Endpoints

Tumor response
Screening and on Day 21 of even numbered cycle
Biomarkers evaluation measured by Enzyme-linked immunosorbent assay (ELISA)
Up to 3 years or longer if indicated
Tumor Response evaluation measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Up to 3 years or longer if indicated
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY1000394EXPERIMENTALApproximately 12 subjects will be included: 3 to 6 evaluable subjects for each cohort. The cycle length will be 3 weeks (21 days).
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
BAY1000394 (2.5mg)DRUGBAY1000934 2.5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 1)
BAY1000394 (5mg)DRUGBAY1000934 5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 2)
BAY1000394DRUGBAY1000394 will be administered orally twice a day (bid) in a 4 week on / 2 week off schedule.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Japanese male or female subjects aged ≥20 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 * Life expectancy of at least 12 weeks * Subjects with advanced, histologically or cytologically confirmed solid tumors, not amenable to any standard therapy...

Countries:JapanUnited States
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Competitive Landscape -Myeloproliferative Neoplasms 65 trials (matched to "Neoplasms")

Top 14 of 16 competitors

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY5PHASE3Luspatercept, Fedratinib, BMS-986158
AbbVie, Inc.ABBV4PHASE3Navitoclax, ABBV-744, IMGN632
Novartis AG Sponsored ADRNVS3PHASE3Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2PHASE3Elritercept
Geron CorporationGERN2PHASE3Imetelstat
Incyte CorporationINCY8PHASE2Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978
Merck & Co., Inc.MRK1PHASE3Bomedemstat
GSK plc Sponsored ADRGSK3PHASE2Momelotinib
Eli Lilly and CompanyLLY2PHASE1LY3410738, LY5830966
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Damora Therapeutics, Inc.DMRA2PHASE2GB2064, DMR-001
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
Syndax Pharmaceuticals IncSNDX1PHASE1Revumenib
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Frequently asked questions about BAY1000394

What is BAY1000394 used for?

BAY1000394 is an investigational small molecule being studied in oncology for the treatment of neoplasms, which are abnormal tissue growths that can be cancerous. It has been evaluated in Phase 1 clinical trials in patients with advanced malignancies. It is not an approved therapy.

Who is developing BAY1000394?

BAY1000394 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored both Phase 1 studies of the compound in patients with neoplasms.

What phase is BAY1000394 in?

BAY1000394 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The studies enrolled a total of 22 patients and evaluated the drug as a monotherapy in advanced malignancies.

What clinical trials is BAY1000394 in?

BAY1000394 has been studied in two completed Phase 1 trials: NCT02047890, a Japanese monotherapy study in neoplasms that enrolled 12 patients, and NCT01335256, a dose-escalation study of a 4 week on / 2 week off schedule in advanced malignancies that enrolled 10 patients in the United States.

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