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S-8184 Paclitaxel Injectable Emulsion

Phase 2

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Achieve Life Sciences, Inc.|Last Updated: Jun 4, 2009

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 Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00034164Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung CancerPHASE2 COMPLETED 52Apr 1, 2002Sep 1, 2007Jun 4, 20091 Russia
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Study Endpoints
Primary Endpoints
To determine the objective response rate
After all patients completed therapy
Secondary Endpoints
To determine time to disease progression
After all patients completed therapy
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
S-8184 Paclitaxel Injectable EmulsionDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Histologic diagnosis of non small cell lung cancer Relapsed or unresectable stage IIIB or IV disease One and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent dosed at 60 mg/m2 or higher per cycle for cisplatin and AUC 6 per cycle for carb...

Countries:Russia
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