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P501-AS15 vaccine

Phase 1

Neoplasms, Prostate | Monoclonal antibody | Oncology |GSK plc|Last Updated: Jun 2, 2017

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 Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00148928Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSAPHASE1 COMPLETED 25 — — Mar 1, 2005Nov 7, 2006Jun 2, 20178 Belgium, France
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Study Endpoints
Primary Endpoints
Vaccine-related or possibly vaccine-related Grade 3 or 4 adverse event: a. Any Grade 4 toxicity: fatigue (including lethargy, asthenia, malaise) must have a duration of at least 24 hours. b. Any Grade 3 toxicity with a duration of at least 24 hours
During the study
Clinical PSA response
Secondary Endpoints
a. For patients who present a PSA response: The duration of PSA response, The duration of PSA control, The duration of log PSA response.
During the study
b. Humoral immune response induced by P501-AS15 vaccine: Anti-CPC seropositivity. Anti-P501 seropositivity.
At all points during treatment as specified in the study schedule
c. Cellular immune response induced by P501-AS15 vaccine. Frequency of in vitro cellular immune response to CPC P501.
At all points during treatment as specified in the study schedule
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
P501-AS15 vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexMALE
Healthy VolunteersNo
Study Sites8

Inclusion criteria: * Male, * Aged between 18 and 75 years, inclusive, * Histologically or cytologically proven adenocarcinoma of the prostate before the initiation of therapy of the primary tumor, * Radical prostatectomy before progression of disease by rising PSA was established, * Primary tumor ...

Countries:BelgiumFrance
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