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ZIO-101

Phase 1

Solid Tumors | Small molecule | Oncology |Alaunos Therapeutics, Inc.|Last Updated: Aug 1, 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 Trials2
Total Enrollment87
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00509782Phase I Trial of ZIO-101 in Patients With Solid TumorsPHASE1 COMPLETED 47May 1, 2005Apr 1, 2008Aug 1, 20121 United States
NCT00591396A Phase I Trial of ZIO-101 in Solid TumorsPHASE1 COMPLETED 40Jul 1, 2005Jul 1, 2008Jul 19, 20121 United States
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Study Endpoints
Primary Endpoints
Maximum tolerated dose (MTD)
Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD
toxicities
6 months
Secondary Endpoints
pharmacokinetics
6 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZIO-101EXPERIMENTAL -
Single ArmEXPERIMENTAL -
Interventions
NameTypeDescription
ZIO-101DRUGStarting Dose 78 mg/m\^2 intravenously daily for 5 consecutive days repeated every 4 weeks.
ZIO-101 (Darinaparsin)DRUGDose Escalation of ZIO-101 (Darinaparsin) given daily for five consecutive days to be repeated every 28 days for up to six months
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition. 2. Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary les...

Countries:United States
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