CompletedPhase 1

AGN-Cogni.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients

United States12 participantsStarted 2023-05-02

Plain-language summary

This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients.

Age range40 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Willingness and ability to give informed consent.
✓. Agree to comply with all study procedures and attend all study visits to the best of their ability.
✓. Male with age \>=40 years.
✓. History of prostate cancer diagnosis. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. Subjects are eligible if meet one or more of the below criteria:
✓. Patients treated forprostate cancer and no detectable disease on imaging and clinical determination are eligible for enrollment, regardless of risk category.
✓. Patients in the low-risk and favorable intermediate-risk groups who are not currently receiving any treatment or have declined any treatment.
✓. Not on concurrent androgen deprivation therapy.
✓. ECOG performance status 0-2.

✕. Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment.
✕. Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor).
✕. Subjects who are receiving any other investigational agents.
✕. Uncontrolled intercurrent illness that would limit compliance with study requirements.
✕. All vulnerable patient populations.
✕. History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, any uncontrolled cardiac arrhythmia, or any other cardiac related problem that would be considered a contraindication for participation in the opinion of the treating physician.
✕. Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens.
✕. Subjects who are taking Warfarin/Coumadin.

Cardiac Safety Via Electrocardiography (EKG)

Timeframe: Baseline (pre-dose) and 5 hours post-dose on each dosing day and at 24 hours (Up to 5 weeks).

Safety Blood Laboratory Tests

Timeframe: 24 hours post-dose and prior to each subsequent dose level (Up to 5 weeks).

NCT IDNCT05375539

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-15

Results submitted2026-02-13

Who can participate

Age range40 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Willingness and ability to give informed consent.
✓. Agree to comply with all study procedures and attend all study visits to the best of their ability.
✓. Male with age \>=40 years.
✓. History of prostate cancer diagnosis. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded. Subjects are eligible if meet one or more of the below criteria:
✓. Patients treated forprostate cancer and no detectable disease on imaging and clinical determination are eligible for enrollment, regardless of risk category.
✓. Patients in the low-risk and favorable intermediate-risk groups who are not currently receiving any treatment or have declined any treatment.
✓. Not on concurrent androgen deprivation therapy.
✓. ECOG performance status 0-2.

✕. Subjects with distant metastatic cancer. Node positive prostate cancer patients are allowed after completion of treatment.
✕. Subjects who are receiving chemotherapy, or oral TKI, or immunotherapy (checkpoint inhibitor).
✕. Subjects who are receiving any other investigational agents.
✕. Uncontrolled intercurrent illness that would limit compliance with study requirements.
✕. All vulnerable patient populations.
✕. History of New York Heart Association Class III or IV heart failure, history of a myocardial infarction within 6 months, any uncontrolled cardiac arrhythmia, or any other cardiac related problem that would be considered a contraindication for participation in the opinion of the treating physician.
✕. Use of androgen deprivation therapy (ADT) or anti-androgen therapy including LHRH agonist, antagonist, GNRH analogs, and antiandrogens.
✕. Subjects who are taking Warfarin/Coumadin.