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indibulin

Phase 1

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 Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00591136Phase I Study of Indibulin in Patients With Solid TumorsPHASE1 COMPLETED 47Apr 1, 2003Sep 1, 2008Jul 19, 20122 Netherlands
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Study Endpoints
Primary Endpoints
toxicities
4 months
Secondary Endpoints
pharmacokinetics
4 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single ArmEXPERIMENTAL -
Interventions
NameTypeDescription
indibulinDRUGDose escalation, daily dosing for 14 days every 3 weeks, for up to 4 months
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria * Male or female patient, \>= 18 years of age. * Histologically/cytologically proven solid malignant tumor, for which standard treatment of proven efficacy are not or no longer available. * Performance status 0-2 ECOG/WHO. * Life expectancy \> 3 months. * Able and willing to unde...

Countries:Netherlands
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