← Back to Search

Monoclonal Antibodies

Daratumumab + FMS Inhibitor for Prostate Cancer

Phase 1

Waitlist Available

Led By Sumit K Subudhi

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

Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection.

No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 18

Awards & highlights

Study Summary

This trial is testing the side effects of two drugs, daratumumab and FMS inhibitor JNJ-40346527, before surgery in treating patients with high-risk prostate cancer.

Who is the study for?

Men with high-risk, localized or locally advanced prostate cancer that can be surgically removed and have not had previous treatments for it. They must have a normal testosterone level, no metastatic disease, and be fit for surgery. Participants should agree to use condoms during sexual activity while on the study drug and for 3 months after the last dose.Check my eligibility

What is being tested?

The trial is testing daratumumab or FMS inhibitor JNJ-40346527 given before surgery to see if they improve outcomes in patients with high-risk prostate cancer. Daratumumab is an immunotherapy monoclonal antibody, while JNJ-40346527 blocks enzymes needed by tumor cells.See study design

What are the potential side effects?

Potential side effects include immune system reactions, possible organ inflammation due to daratumumab's action on the body's immune response, as well as risks associated with blocking cell growth enzymes from JNJ-40346527.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 18 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

Secondary outcome measures

Immune changes in blood

Immune changes in tumor tissue

Pathological complete response (CR)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (FMS inhibitor JNJ-40346527)Experimental Treatment2 Interventions

Patients receive FMS inhibitor JNJ-40346527 PO BID for 4-5 weeks in the absence of disease progression or unacceptable toxicity. After a 3 day wash-out period, patients undergo radical prostatectomy.

Group II: Arm A (daratumumab)Experimental Treatment2 Interventions

Patients receive daratumumab IV over 4-8 hours once weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo radical prostatectomy during week 6.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FMS Inhibitor JNJ-40346527

2017

Completed Phase 1

~40

Daratumumab

2014

Completed Phase 3

~1860

Radical Prostatectomy

2005

Completed Phase 2

~4550

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,748 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,120 Total Patients Enrolled

Sumit K SubudhiPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

31 Total Patients Enrolled

Frequently Asked Questions

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

Are there any openings available in this experimental research endeavor?

"Alas, clinicaltrials.gov presently states that this medical trial is not recruiting participants. It was first made available to the public on June 7th 2017 and its information has been modified as recently as February 25 2022. Nonetheless, there are still a plethora of other trials actively searching for volunteers at current moment."

Answered by AI

Has the FDA sanctioned JNJ-40346527 as a treatment for FMS?

"There is limited data surrounding the safety and efficacy of FMS Inhibitor JNJ-40346527, thus Power gave it a rating of 1 on their scale."

Answered by AI

To what conditions is FMS Inhibitor JNJ-40346527 routinely deployed?

"JNJ-40346527, a FMS inhibitor, is prescribed to modify biological responses. It can also assist patients dealing with refractory multiple myeloma, relapsed or refractory multiple myeloma, and cell transplants."

Answered by AI

Has JNJ-40346527 been experimented with in previous medical studies?

"Currently, 140 clinical trials involving FMS Inhibitor JNJ-40346527 are in operation with 26 within the late stages of their process. The majority of these tests take place around Harrison, New york - though there is a total 5574 locations running studies for this drug."

Answered by AI

How many subjects are being monitored in this empirical research?

"This trial has concluded its participant recruitment stage. It was initially published on June 7th 2017, and the listing was modified for the last time on February 25th 2022. For those that are seeking other clinical trials, 1275 studies for malignant neoplasms of prostate and 140 related to FMS Inhibitor JNJ-40346527 are currently recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer

2017. "Daratumumab or FMS Inhibitor JNJ-40346527 Before Surgery in Treating Patients With High-Risk, Resectable Localized or Locally Advanced Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03177460.