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BMS-907351

Phase 1

Neoplasms | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jan 7, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment3
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01018745Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in JapanPHASE1 COMPLETED 3 — — Jan 1, 2010Jul 1, 2010Jan 7, 20111 Japan
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Study Endpoints
Primary Endpoints
To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
Within the first 28 days
Secondary Endpoints
To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter
To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors
Day 1, 5, 15, 19 and 29
To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184)
Every 8 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-907351 (XL184)EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-907351 (XL184)DRUGCapsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group performance 0-2 Exclusion Criteria: * Subject has uncontrolled intercurrent illness

Countries:Japan
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Competitive Landscape -Myeloproliferative Neoplasms 53 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY5PHASE3ACE-536, Luspatercept, Fedratinib, BMS-986158, Ruxolitinib
AbbVie, Inc.ABBV4PHASE3Navitoclax, Ruxolitinib, Celecoxib, ABBV-744, IMGN632
Novartis AG Sponsored ADRNVS3PHASE3Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor, Ruxolitinib, Pacritinib, Momelotinib
Geron CorporationGERN2PHASE3Imetelstat, Ruxolitinib
Incyte CorporationINCY11PHASE2itacitinib, Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C
Merck & Co., Inc.MRK1PHASE3Bomedemstat
GSK plc Sponsored ADRGSK2PHASE2MMB, Momelotinib, Luspatercept
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Elritercept, Ruxolitinib
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Galecto, Inc.GLTO1PHASE2GB2064
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
United Therapeutics CorporationUTHR1PHASE2bomedemstat
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