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ADH-1

Phase 2

Neoplasms | Small molecule | Oncology |Fennec Pharmaceuticals Inc.|Last Updated: Dec 28, 2010

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 Trials4
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00264433A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single AgentPHASE2 COMPLETED - - -Aug 6, 200711 United States, Canada
NCT00421811A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of MelphalanPHASE1 COMPLETED 56Apr 1, 2007Mar 1, 2009Dec 28, 20107 United States
NCT00390676A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or CapecitabinePHASE1 COMPLETED -Nov 1, 2006Nov 1, 2009Dec 28, 201010 United States
NCT00265057Study of ADH-1 Given Intravenously to Patients With Solid TumorsPHASE1 COMPLETED -Jun 1, 2005Jan 1, 2008Dec 28, 20103 Italy, Switzerland
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Study Endpoints
Primary Endpoints
To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions
By Week 12
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ADH -1 (Exherin™)DRUG -
ADH-1DRUG4 gm IV Days 1 and 8
melphalanDRUGBy Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1
ADH -1 and carboplatinDRUG -
ADH -1 and docetaxelDRUG -
ADH -1 and capecitabineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Signed written informed consent * Male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists * Histologically proven advanced and/or metastatic solid tumor of one of the following histo...

Countries:United StatesCanadaItalySwitzerland
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