← Back to Search

Monoclonal Antibodies

ADI-PEG 20 + Chemotherapy for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Ana Aparicio, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Male aged 18 years and above

Histologically or cytologically confirmed prostate carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial tests a drug combo to see what dose works best to treat advanced prostate cancer.

Who is the study for?

This trial is for men over 18 with aggressive variant prostate cancer (AVPC) that has spread, as shown by scans. They must consent to tissue collection and agree to birth control if their partners can have children. Participants need good organ function, low testosterone levels on treatment, and a performance status score of ≤2. Men who've had more than one chemo or specific drugs for CRPC aren't eligible.Check my eligibility

What is being tested?

The study aims to find the safest dose of ADI-PEG20 when used with carboplatin and cabazitaxel in treating AVPC. It's a phase I/II trial which means they're looking at safety, side effects, and early signs of how well it works.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system due to ADI-PEG20 or pegylated compounds, blood disorders from chemotherapy agents like carboplatin and cabazitaxel, fatigue, digestive issues such as nausea or diarrhea, increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a man aged 18 or older.

Select...

My prostate cancer has been confirmed by a lab test.

Select...

My cancer has spread to other parts of my body, confirmed by scans.

Select...

I have undergone treatment to lower my testosterone levels below 50 ng/dL.

Select...

I can perform daily activities with minimal assistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and Monotherapy MaintenanceExperimental Treatment3 Interventions

Participants will be assigned to a study group and dose level of ADI-PEG20 based on when participant join this study. Up to 2 dose levels of ADI-PEG20 may be tested. Up to 15 participants will be enrolled per dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADI-PEG 20

2013

Completed Phase 2

~190

Cabazitaxel

2014

Completed Phase 3

~1290

Carboplatin

2014

Completed Phase 3

~6670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,444 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,710 Patients Enrolled for Prostate Cancer

Ana Aparicio, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

Are volunteers still being sought for this trial?

"According to the information on clinicaltrials.gov, this particular medical trial is not actively recruiting patients; it was initially posted on March 1st 2024 and last updated on October 10th 2023. Although enrollment in this specific study has ceased, there are still 2207 other trials seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

2024. "Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085729.