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BAY1163877

Phase 1

Neoplasms | Small molecule | Oncology |Bayer AG|Trials Updated: Apr 18, 2018

BAY1163877 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

BAY1163877 clinical trials

BAY1163877 · 1 trial · 1 indication

Phase 1 1
NCT02592785Phase I Dose Escalation Study of BAY 1163877 (Rogaratinib) in Japanese Subjects With Refractory, Locally Advanced or Metastatic Solid TumorsNeoplasms
COMPLETED9 Analytics
PHASE1COMPLETED
Phase I Dose Escalation Study of BAY 1163877 (Rogaratinib) in Japanese Subjects With Refractory, Locally Advanced or Metastatic Solid Tumors
Neoplasms
NCT025927859
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Study Endpoints

Primary Endpoints

Number of an Treatment Emergent Adverse Event
Up to 35 days after the last study drug administration
Intensity of an Treatment Emergent Adverse Event graded using the NCI-CTCAE version 4.03
Up tp 35 days after the last study drug administration
Maximum observed plasma concentration after single dose administration (Cmax) of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
Cmax divided by dose (mg) per kg body weight (Cmax,norm) of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
Cmax divided by dose (mg) (Cmax/D) of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
Area under the plasma concentration vs time curve from zero to 12 hours p.a. after first-dose administration (AUC(0-12)) of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
AUC(0-12) divided by dose (mg) per kg body weight (AUC(0-12) norm) of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
AUC(0-12) divided by dose (mg) (AUC(0-12)/D) of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
AUC from time zero to the last data point > LLOQ (lower limit of quantification) of BAY1163877 (AUC(0-tlast))
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
AUC(0-tlast) divided by dose (mg) per kg body weight (AUC(0-tlast) norm) of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
AUC(0-tlast) divided by dose (mg) (AUC(0-tlast)/D) of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
AUC of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
AUCnorm of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
AUC/D of BAY1163877
On cycle 1, Day 1 to 3 (single-dose): Pre- dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post-dose
Maximum Observed Drug Concentration in Plasma after multiple administrations (Cmax, md) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
Cmax after multiple administrations divided by dose (mg) per kg body weight (Cmax,norm, md) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
Cmax after multiple administrations divided by dose (mg) (Cmax/Dmd) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
AUC(0-12) after multiple administrations (AUC(0-12)md) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
AUC(0-12) after multiple administrations divided by dose (mg) per kg body weight (AUC(0-12)norm,md) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
AUC(0-12) divided by dose (mg) after multiple administrations (AUC(0-12)/Dmd) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
AUC(0-tlast)after multiple administrations (AUC(0-tlast)md) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
AUC(0-tlast) after multiple administrations divided by dose (mg) per kg body weight (AUC(0-tlast) norm,md) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose
AUC(0-tlast) after multiple administrations divided by dose (mg) (AUC(0-tlast)/Dmd) of BAY1163877
On cycle 1, Day 15 during multiple-dose: before morning dose and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose

Secondary Endpoints

Tumor response evaluation based on RECIST 1.1
Screening, end of every second cycle (i.e., Cycle 2, 4, 6, 8,…)
FGF23 levels
Cycle 1 (Days 1 and 15)
Phosphate levels
Cycle 1 (Days 1, 8, 15), Cycle 2 to 12 (Days 1, 8, 15), Cycle ≥13 (Days 1, 11), end of treatment
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BAY1163877EXPERIMENTALCohort 1: Safety, tolerability and PK of 600 mg dose given twice daily. Escalation to cohort 2 in case no safety relevant adverse event has been observed within 21 days after start of study treatment Cohort 2: Safety, tolerability and PK of 800 mg dose given twice daily

Interventions

NameTypeDescription
BAY1163877DRUGCohort 1: Single dose 600 mg on day 1, no drug on day 2 and then twice daily administration of the same dose for the remaining 19 days of cycle 1. From cycle 2 onwards all subjects are continuously treated for 21 days per cycle with twice daily administration of the same dose. Cohort 2: Single dose 800 mg on day 1, no drug on day 2 and then twice daily administration of the same dose for the remaining 19 days of cycle 1. From cycle 2 onwards all subjects are continuously treated for 21 days per cycle with twice daily administration of the same dose.
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Eligibility Criteria

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

Inclusion Criteria: * Japanese males or female aged ≥ 20 years * Histologically or cytologically confirmed refractory, locally advanced or metastatic solid tumors who are not candidates for standard therapy at discretion of investigator * High FGFR expression levels based on archival or fresh tumor...

Countries:Japan
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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 BAY1163877

What is BAY1163877?

BAY1163877 is an investigational small molecule oncology drug developed by Bayer AG. It was studied in a Phase 1 dose escalation trial in Japanese subjects with refractory, locally advanced or metastatic solid tumors. It is also known as rogaratinib.

What is BAY1163877 used for?

BAY1163877 was studied for the treatment of neoplasms, specifically refractory, locally advanced or metastatic solid tumors. The trial enrolled patients with these advanced cancers in Japan. It is an investigational agent and is not an approved treatment.

Who makes BAY1163877?

BAY1163877 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 clinical trial of the drug in Japanese subjects with refractory, locally advanced or metastatic solid tumors.

What phase is BAY1163877 in?

BAY1163877 is in Phase 1 development. It has been evaluated in a single Phase 1 dose escalation study, which is now completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is BAY1163877 in?

BAY1163877 was studied in one clinical trial, NCT02592785, titled a Phase I Dose Escalation Study of BAY 1163877 (Rogaratinib) in Japanese Subjects With Refractory, Locally Advanced or Metastatic Solid Tumors. The trial enrolled 9 participants in Japan and is completed.

Is BAY1163877 the same as rogaratinib?

Yes, BAY1163877 is also known as rogaratinib. Both names refer to the same investigational small molecule developed by Bayer AG. The Phase 1 trial NCT02592785 lists the drug under both designations.

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