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Custirsen, paclitaxel and carboplatin

Phase 1

Cancer | Small molecule | Oncology |Achieve Life Sciences, Inc.|Last Updated: Oct 10, 2016

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01497470A Clinical Study in Cancer Patients to Investigate the Potential Impact of Custirsen, on the Blood Levels of the Chemotherapeutic Drug, Paclitaxel, When Given Together as Part of a Treatment RegimenPHASE1 COMPLETED 36Apr 1, 2012Oct 1, 2013Oct 10, 20164 United States
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Study Endpoints
Primary Endpoints
To evaluate the impact of custirsen on paclitaxel pharmacokinetics
0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion

The maximum peak concentration of paclitaxel after administration.

Secondary Endpoints
To evaluate the safety and tolerability of adding custirsen to standard paclitaxel/carboplatin chemotherapy
0, 1, 2, 3, 3.25, 3.67, 4.5, 6, 8, 12, 24 and 48 hours after the start of paclitaxel infusion
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Paclitaxel/carboplatin with custirsenEXPERIMENTALCustirsen added to standard paclitaxel/carboplatin chemotherapy
Interventions
NameTypeDescription
Custirsen, paclitaxel and carboplatinDRUGCustirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Confirmed diagnosis of a solid tumor that is refractory to standard therapies and is not amenable to treatment with established curative or palliative therapies and for whom paclitaxel and carboplatin is deemed an acceptable treatment by the investigator * Males or females ≥18...

Countries:United States
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