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AC176 for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Accutar Biotechnology Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have had surgical or medical castration
Patients must have progressed on at least 2 prior approved systemic therapies (in any setting), with at least 1 being abiraterone, or enzalutamide, or apalutamide or darolutamide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, approximately 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, AC176, on people with prostate cancer that has spread and is resistant to hormone therapy. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for males over 18 with advanced prostate cancer that's resistant to castration and has worsened after at least two systemic therapies. Participants must have a life expectancy of more than three months, be able to swallow pills, and not plan on fathering children during the study.Check my eligibility
What is being tested?
The drug AC176 is being tested in this trial. It aims to find a safe dose, understand side effects, how the body processes it (pharmacokinetics), and its effectiveness against metastatic castration-resistant prostate cancer.See study design
What are the potential side effects?
While specific side effects of AC176 are not listed here, common ones in such trials include nausea, fatigue, allergic reactions, heart issues like QT prolongation (a type of irregular heartbeat), and potential risks related to liver or kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have undergone surgical or medical castration.
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My cancer has worsened after two treatments, including one like abiraterone.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events (AEs)/Serious adverse events (SAEs)
Incidence of Electrocardiogram (ECG) abnormalities as a measure of safety and tolerability of AC176
Incidence of dose limiting toxicities (DLTs) from AC176 monotherapy
+2 more
Secondary outcome measures
Objective Response Rate(ORR)
Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))
Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AC176 Dose Escalation as Single AgentExperimental Treatment1 Intervention
Single agent dose escalation of AC176. AC176 will be given orally (PO) on a 28-day cycle.

Find a Location

Who is running the clinical trial?

Accutar Biotechnology IncLead Sponsor
5 Previous Clinical Trials
164 Total Patients Enrolled

Media Library

AC176 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05241613 — Phase 1
Prostate Cancer Research Study Groups: AC176 Dose Escalation as Single Agent
Prostate Cancer Clinical Trial 2023: AC176 Highlights & Side Effects. Trial Name: NCT05241613 — Phase 1
AC176 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05241613 — Phase 1

Frequently Asked Questions

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

Has AC176 received regulatory clearance from the Food and Drug Administration?

"The safety of AC176 has been given a provisional score of 1, due to the fact that it is presently undergoing Phase 1 trials. This signifies there are limited clinical data affirming its efficacy and security profile."

Answered by AI

What is the population size of this scientific investigation?

"Indeed, clinicaltrials.gov proclaims that this medical trial is now recruiting participants. The study was originally shared on March 16th 2022 and recently updated on April 6th 2022. 36 individuals need to be recruited from 4 distinct sites."

Answered by AI

In what geographic areas is this clinical trial being conducted?

"Patients are being recruited at Site 04 in Dallas, Texas; Site 02 in Denver, Colorado; and Site 01 in Nashville, Tennessee among other locations."

Answered by AI

Have recruitment efforts for this trial commenced?

"As indicated on clinicaltrials.gov, this research project is currently recruiting participants and has been since March 16th 2022 when it was initially posted, with the last updates occurring April 6th of the same year."

Answered by AI
~0 spots leftby Apr 2024