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BMS-690514 / FOLFIRI

Phase 1

Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 30, 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
ACTIVE_CONTROLLEDBiomarker
Total Trials3
Total Enrollment123
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00516451Phase I Study of BMS-690514 in Japanese Patients With Solid TumorsPHASE1 COMPLETED 9 — — Nov 1, 2007Jul 1, 2008Oct 13, 20081 Japan
NCT00479583Combination Trial of BMS-690514 in Combination With FOLFIRI and FOLFOXPHASE1 COMPLETED 25 — — Sep 1, 2007Apr 1, 2010Nov 30, 20114 United States, France
NCT00329004A Phase I Study of BMS-690514 in Patients With Advanced or Metastatic Solid TumorsPHASE1 COMPLETED 89 — — Aug 1, 2006Jul 1, 2009Jan 25, 20117 United States, Canada +2
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Study Endpoints
Primary Endpoints
To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity of BMS-690514
administered orally every day 28 days
Safety assessment
throughout the study
dose-limiting toxicity (DLT)
assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
determination of maximum tolerated dose (MTD)
during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
Safety
results of weekly vital sign measurements, ECGs, laboratory tests and physical exams, echocardiograms every 8 weeks
Highest dose tolerated
continuous medical review of adverse event reports
Secondary Endpoints
Evaluate safety, exposure levels of BMS-690514 in the body & anticancer activity of BMS-690514 administered orally every day for 28 days.
throughout the study
Safety evaluations and laboratory assessments will be performed
throughout the study
Preliminary markers of efficacy will also be assessed
throughout the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
Interventions
NameTypeDescription
BMS-690514DRUGTablets, Oral, 100, 200, 250 or 300 mg once daily, 29 days or more
BMS-690514 / FOLFIRIDRUGTablets / IV, Oral / IV, up to 200 mg / irinotecan 180mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
BMS-690514 / FOLFOXDRUGTablets / IV, Oral / IV, up to 200 mg / oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5FU 400mg/m2 bolus, 2400 mg/m2 inf, once daily / q 2 weeks, up to 24 mos
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate, with adequate kidney, liver and cardiac function.

Countries:JapanUnited StatesFranceCanadaSpain
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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