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Recently added Catalysts

isolated perfusion

Phase 2

Cancer | Small molecule | Oncology |Delcath Systems, Inc.|Last Updated: Oct 23, 2013

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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00096083Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver CancerPHASE2 COMPLETED 56Sep 1, 2004Aug 1, 2012Oct 23, 20131 United States
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Study Endpoints
Primary Endpoints
To determine the response rate and duration of response to intra-hepatic infusion of melphalan with subsequent venous hemofiltration in patients with primary and metastatic hepatic malignancies
Survivial
Secondary Endpoints
To determine the patterns of recurrence following percutaneous hepatic perfusions (PHP) with melphalan
Survival
To determine the progression free and overall survival in patients with hepatic malignancies following this therapy
Survivial
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Melphalan Administration PHPACTIVE_COMPARATOR -
Interventions
NameTypeDescription
isolated perfusionDRUG -
melphalanDRUG -
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hepatic malignancy * Unresectable disease * Disease predominantly in the parenchyma of the liver * One of the following primary tumor histologies: * Adenocarcinoma of gastrointestinal or other origin * Neuroendocri...

Countries:United States
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