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darinaparsin

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Jul 19, 2012

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01139346Study of Oral Darinaparsin in Patients With Advanced Solid TumorsPHASE1 COMPLETED 12Jun 1, 2010Apr 1, 2012Jul 19, 20123 United States
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Study Endpoints
Primary Endpoints
Determine Toxicity Profile
One Year

a primary outcome measure is to determine the toxicity profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle

Determine Maximum Tolerated Dose
One Year

a primary outcome measure is to determine the maximum tolerated dose of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle

Determine the preliminary activity/efficacy
One Year

a primary outcome measure is to determine the preliminary activity/efficacy of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle

Determine Pharmacokinetic profile
One Year

a primary outcome measure is to determine the pharmacokinetic profile of oral darinaparsin when given continuously for 21 days followed by a 7 day rest period per cycle

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
oral darinaparsinEXPERIMENTALopen label, single arm, dose escalation
Interventions
NameTypeDescription
darinaparsinDRUGdose escalating, starting at 200 mg twice per day for 21 days continuous followed by a 7 day rest per cycle.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Subjects with histological or cytological confirmation of advanced cancer (solid tumor) that is refractory to standard therapies for their condition; * Men and women of ≥18 years of age; * ECOG performance score ≤2 * Eligible subjects with solid tumors MUST have at least one m...

Countries:United States
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