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Indium labeled IMP-205xm734

Phase 1

Colonic Neoplasms | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Apr 7, 2016

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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00185081Imaging Colo-rectal Cancer Using a Two Step Antibody Technique in Nuclear ImagingPHASE1 COMPLETED 42Jul 1, 2005Dec 1, 2008Apr 7, 20161 Netherlands
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Study Endpoints
Primary Endpoints
Safety evaluation of intravenous injection of In-labeled IMP-205 and hMN-14xm734
Tumor targeting of In-IMP-205 in patients with colorectal carcinoma
Pharmacokinetics, biodistribution and dosimetry of In-IMP-205
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
Indium labeled IMP-205xm734DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * \> 18 years of age * Histologic or cytologic diagnosis of colorectal cancer * Karnofsky performance status \>70% Exclusion Criteria: * Pregnant or lactating women * Severe anorexia * Active second primary malignancy * Chemotherapy or radiotherapy within four weeks of study e...

Countries:Netherlands
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