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ABI-007 and Carboplatin

Phase 2

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 12, 2019

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 Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00274443An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With CarboplatinPHASE2 COMPLETED 250Mar 1, 2005Jun 1, 2007Nov 12, 20191 Russia
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Study Endpoints
Primary Endpoints
Safety Outcomes: incidence of treatment emergent adverse events.
Treatment duration
Efficacy Outcomes: percentage of patients who achieve an objective confirmed complete or partial overall antitumor response
Treatment duration
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABI-007 and CarboplatinEXPERIMENTALABI-007 and Carboplatin in patients with Advanced Non-Small Cell Lung Cancer.
Interventions
NameTypeDescription
ABI-007 (Abraxane) and CarboplatinDRUGABI-007 plus Carboplatin will be administered intravenously over 30 minutes in cycles of 3 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically or cytologically confirmed NSCLC Stage IIIB with pleural effusion or evidence of inoperable local recurrence or metastasis (Stage IV). * Male or non-pregnant and non-lactating female, and ≥ 18 years of age. ( )If a female patient is of child-bearing potential, a...

Countries:Russia
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