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P501-AS15 vaccine

Phase 1

Neoplasms, Prostate | Vaccine | Oncology |GSK plc|Trials Updated: Jun 2, 2017

P501-AS15 vaccine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2005

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

P501-AS15 vaccine clinical trials

P501-AS15 vaccine · 1 trial · 1 indication

Phase 1 1
NCT00148928Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSANeoplasms, Prostate
COMPLETED25 Analytics
PHASE1COMPLETED
Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA
Neoplasms, ProstateUnlock trial analytics

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 to 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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Frequently asked questions about P501-AS15 vaccine

What is P501-AS15 vaccine used for?

P501-AS15 vaccine is an investigational immunotherapy studied as a first-line treatment for hormone-sensitive prostate cancer in patients who show rising prostate-specific antigen (PSA) levels. It is being developed by GSK plc for prostate cancer and related neoplasms. It has not been approved for any indication.

Who is developing P501-AS15 vaccine?

P501-AS15 vaccine is being developed by GSK plc, which trades under the ticker GSK. The company is responsible for the clinical program evaluating the vaccine in prostate cancer.

What phase is P501-AS15 vaccine in?

P501-AS15 vaccine is in Phase 1 clinical development. It is an investigational product and has not received FDA approval. The Phase 1 trial has been completed.

What clinical trials is P501-AS15 vaccine in?

P501-AS15 vaccine has been evaluated in one completed Phase 1 trial, NCT00148928, titled "Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA." The trial enrolled 25 male patients aged 18 years and older in Belgium and France.

How does P501-AS15 vaccine work?

P501-AS15 vaccine is a vaccine-based immunotherapy designed to stimulate an immune response against prostate cancer. It is being studied in patients with hormone-sensitive prostate cancer who have rising PSA levels after initial treatment.