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Tomudex

Phase 2

Inoperable or Recurrent Rectal Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 25, 2008

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 Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00590278A Phase-II Study Of TOMUDEX Plus Radiotherapy In Subject With Inoperable or Recurrent Rectal CancerPHASE2 COMPLETED 49Aug 1, 2002 -Jan 25, 20081 Turkey (Türkiye)
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Study Endpoints
Primary Endpoints
This study will evaluate the value of TOMUDEX in combination with a 'standard' course of pelvic radiotherapy for inoperable/recurrent rectal cancer, in terms of response rate and increasing the resectability rate
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
TomudexDRUG -
RadiotherapyPROCEDURE -
HaematologyPROCEDURE -
BiochemistryPROCEDURE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Confirmed diagnosis of inoperable/recurrent rectal cancer * Age \> 18 years * At least 1 measurable lesion should be present * WHO performance score \< 2 * Life expentancy of at least 12 weeks * Subjects will be considered appropriate to receive systemic chemotherapy and pelvi...

Countries:Turkey (Türkiye)
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