Your session is about to expire
← Back to Search
FOR46 + Enzalutamide for Prostate Cancer
Study Summary
This trial is testing a new drug, FOR46, to see if it works well with another existing drug, enzalutamide, to treat prostate cancer that has spread and is resistant to hormone therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- My prostate cancer has shown signs of small cell neuroendocrine characteristics.My PSA level is 2 ng/mL or higher, or my cancer can be measured using specific criteria.My blood tests show my organs are functioning well.I agree to have a PET scan for research during my screening.I have a serious heart condition or recent heart attack or stroke.I am willing to have a biopsy of my cancer if it's safe to do so.I haven't taken any strong medication that affects liver enzymes in the last week.I haven't had taxane chemotherapy for metastatic castration-resistant prostate cancer.I am taking more than 10mg of steroids or other immunosuppressants daily.I have a history of seizures or conditions like brain metastasis, stroke, brain bleeding, or lung inflammation.My prostate cancer has spread and was confirmed by a biopsy.I have not had radiotherapy in the last 2 weeks.I have previously been treated with FOR46 or a similar medication.I haven't had major surgery in the last 28 days.I haven't had cancer treatments except LHRH analogues in the last 14 days or 5 half-lives, whichever is shorter.My testosterone levels are very low, and I am on or will stay on hormone therapy if I haven't had surgery to remove my testicles.I have another cancer but it's not being actively treated, except for certain skin, bladder cancers, or early-stage cancers.I haven't needed IV antibiotics for an infection in the last 7 days.I am 18 years old or older.I am mostly active and can carry out light work.My prostate cancer has worsened despite treatment with specific hormone therapies.
- Group 1: Does Escalation
- Group 2: Dose Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has there been prior research related to the use of FOR46?
"Presently, there are 98 ongoing investigations into FOR46 with 30 of these trials in the final Phase 3. Most studies take place within Germantown, Tennessee yet 5740 healthcare facilities around the globe are running clinical research on this drug."
Could you provide an estimate of the upper limit on participants in this research endeavor?
"Affirmative. Data hosted on clinicaltrials.gov verifies that this study is actively searching for participants, which was initially published on January 19th 2022 and most recently updated in June 1st of the same year. 36 people are being recruited from a single medical centre."
Are any new participants currently being admitted for this research effort?
"Affirmative. Clinicaltrials.gov's data demonstrates that enrollment for this clinical trial is ongoing; it was initially posted on 1/19/2022 and recently updated on 6/1/2022, with a target of 36 patients at one site."
What desirable effects does this research endeavor hope to achieve?
"According to the data shared by Fortis Therapeutics, Inc., two-years is the primary timeframe in which they will measure Maximally tolerated dose (MTD) (Phase 1b). Additionally, secondary outcomes such as Median time to PSA progression, Median radiographic progression-free survival and Proportion of participants with a greater than or equal to 50% change in PSA (PSA50) are also being evaluated. The latter outcome specifically defines a ≥ 50% decline from baseline measurements confirmed over four weeks for those deemed psa-evaluable."
Share this study with friends
Copy Link
Messenger