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ISIS 2503

Phase 2

Pancreatic Cancer | Small molecule | Oncology |Ionis Pharmaceuticals, Inc.|Last Updated: Jan 4, 2011

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment4
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00005594ISIS 2503 in Treating Patients With Advanced Cancer of the PancreasPHASE2 COMPLETED 4Jul 1, 2000 -Jan 4, 20112 United States
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Study Endpoints
Primary Endpoints
The primary outcome measure of this study is to estimate the response rate and observe the time to tumor progression of the patients treated on this study.
24 weeks
Secondary Endpoints
Determine the duration of response in responding patients. Further characterize the safety profile of ISIS 2503 at the recommended dose and schedule.
24 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ISIS 2503EXPERIMENTALAll patients will begin treatment at a dose of 6 mg/kg/day of ISIS 2503. ISIS 2503 at the assigned dose will be given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. No drug will be administered during the third week of each treatment cycle.
Interventions
NameTypeDescription
ISIS 2503DRUGBeginning dosage of ISIS 2503 is 6 mg/kg/day given as a continuous i.v. infusion over the first 14 days of a 21-day treatment cycle. This will be repeated for the first two weeks of every three-week treatment cycle.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the pancreas that is considered inoperable Measurable disease with at least 1 lesion measuring at least 2 cm in widest diameter identifiable on CT or MRI scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: E...

Countries:United States
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