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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
No Placebo-Only Group

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 β€œYes” for the criteria below

Timeline

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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2016
Completed Phase 3
~1750
Radical Prostatectomy
2005
Completed Phase 2
~4550

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,943 Previous Clinical Trials
1,775,297 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,576 Previous Clinical Trials
41,224,156 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
~4 spots leftby Feb 2025