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AGN-CognI.Q for Prostate Cancer

Phase 1

Recruiting

Led By Monika Joshi, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not on concurrent androgen deprivation therapy

History of prostate cancer diagnosis in the past. Subjects with history of neuroendocrine or small cell prostate cancer will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-6 weeks

Awards & highlights

Study Summary

This triallooks at how safe and effective a drug is for prostate cancer patients, analyzing its dose and effects.

Who is the study for?

Men over 40 with prostate cancer, not on androgen deprivation therapy or having metastatic cancer. They must have stopped certain herbal supplements and strong CYP3A4/CYPC19 inhibitors/inducers for specific periods before the trial. Participants need normal liver/kidney function, acceptable blood counts, a life expectancy over 12 months, and agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing AGN-CognI.Q's safety at different doses and how it affects the body (pharmacokinetics/pharmacodynamics) in men with prostate cancer. It aims to understand how the drug behaves after an acute dose and its potential effects on this patient group.See study design

What are the potential side effects?

While specific side effects are not listed here, typical ones may include reactions at the site of administration, gastrointestinal issues like nausea or diarrhea, potential liver or kidney function changes, fatigue, allergic reactions or other immune-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently on hormone therapy for cancer.

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I have had prostate cancer before, but it wasn't neuroendocrine or small cell type.

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I can take care of myself and am up and about more than half of the day.

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My liver, kidneys, and bone marrow are functioning well.

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I am a man aged 40 or older.

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I have stopped taking strong CYP3A4 and CYP2C19 inhibitors or inducers for 2 weeks before starting the study.

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I will stop taking supplements with AGN extract 4 weeks before starting the study drug.

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I am willing and able to give my consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Electrocardiography (EKG) QTC Interval

Safety blood lab tests

Secondary outcome measures

Peak Plasma Concentration (Cmax)

Plasma Concentration versus time curve (AUC)

Trial Design

1Treatment groups

Experimental Treatment

Group I: AGN-CognI.QExperimental Treatment1 Intervention

Dose level +1 (800 mg, 4 CognI.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +2 (1,200 mg, 6 CognI.Q capsules, Fast at least 2 h before dose and 1 h after) Dose level +3 (1,600 mg, 8 CognI.Q capsules, Fast at least 2 h before dose and 1 h after)

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

494 Previous Clinical Trials

2,798,830 Total Patients Enrolled

3 Trials studying Prostate Cancer

100 Patients Enrolled for Prostate Cancer

Monika Joshi, MDPrincipal InvestigatorPenn State Cancer Institute

3 Previous Clinical Trials

287 Total Patients Enrolled

Media Library

AGN-CognI.Q (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05375539 — Phase 1

Prostate Cancer Research Study Groups: AGN-CognI.Q

Prostate Cancer Clinical Trial 2023: AGN-CognI.Q Highlights & Side Effects. Trial Name: NCT05375539 — Phase 1

AGN-CognI.Q (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05375539 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study actively enlisting participants?

"Affirmative. Clinicaltrials.gov data confirms that this clinical trial, which was originally published on November 9th 2022, is actively recruiting patients. The research requires 12 participants at a single medical facility."

Answered by AI

How many participants are participating in this investigation?

"Affirmative. Clinicaltrials.gov has published that this research study is actively admitting test subjects, having been initiated on November 9th 2022 and modified most recently on the 15th of November 2022. The investigation seeks 12 individuals from a single medical centre to participate in their trial."

Answered by AI

Has the AGN-CognI.Q product been given regulatory clearance by the FDA?

"The safety of AGN-CognI.Q, which is in its initial phase 1 trial, has been assessed as a score of 1 due to limited evidence on the drug's efficacy or safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Junxuan Lu 2023. "AGN-CognI.Q Acute Dose Safety and Pharmacokinetics Dose-Response in Prostate Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05375539.