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NPI-0052 on Days 1, 8, 15 every 28 days

Phase 1

Advanced Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 22, 2017

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00629473Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced MalignanciesPHASE1 COMPLETED 86 — — Jul 1, 2007Apr 1, 2013Nov 22, 20177 Australia
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Study Endpoints
Primary Endpoints
Determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NPI-0052
Cycle 1 (Arm AM: 28-days, Arm MM: 21-days)

Assess dose-limiting toxicities during Cycle 1 for each treatment arm

Secondary Endpoints
To evaluate the pharmacokinetics activity of NPI-0052
Baseline, Days 1 and 15 (before injection and 1 hour post injection) of Cycle 1
To evaluate the safety and tolerability of NPI-0052
Treatment period through 28-days after the last dose of study drug
To evaluate the pharmacodynamics of NPI-0052
Baseline, Days 1 and 15 (before injection and 1 hour post injection) of Cycles 1 and 2 and of every other cycle thereafter through study completion
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AM: advanced malignanciesEXPERIMENTALDose Escalation - 9 dose cohorts NPI-0052 on Days 1, 8, 15 every 28 days NPI-0052 doses ranging from 0.1 to 0.9 mg/m2
Arm MM: multiple myelomaEXPERIMENTALDose Escalation - 8 dose cohorts NPI-0052 on Days 1, 4, 8, 11 every 21 days NPI-0052 doses ranging from 0.075 to 0.6 mg/m2 Dexamethasone 20 mg oral or IV day before and day after NPI-0052 dosing.
Interventions
NameTypeDescription
NPI-0052 on Days 1, 8, 15 every 28 daysDRUGNPI-0052 dose ranging from 0.1 to 0.9 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 8, and 15 of 4-week cycles
NPI-0052 on Days 1, 4, 8, 11 every 21 daysDRUGNPI-0052 dose ranging from 0.075 to 0.6 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 4, 8, and 11 of 3-week cycles
DexamethasoneDRUG20 mg oral or IV day before and day after NPI-0052 dosing.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Karnofsky Performance Status (KPS) \> 70%. * Histologically-confirmed advanced malignancy for which a standard, approved therapy is not available. * Adequate renal, liver, pancreatic and hematologic function * Signed informed consent (sample IC form is provided in Appendix A)....

Countries:Australia
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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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