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Androgen Receptor Antagonist

FT-7051 for Prostate Cancer

Phase 1
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Signed informed consent
Diagnosis of progressive metastatic castration-resistant prostate cancer (mCRPC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood samples for pk analysis collected at multiple visits during the first 90 days of treatment
Awards & highlights

Study Summary

This trial is testing a new drug, FT-7051, to see if it is safe and effective in treating men with metastatic castration-resistant prostate cancer.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples for pk analysis collected at multiple visits during the first 90 days of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples for pk analysis collected at multiple visits during the first 90 days of treatment 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 clinical laboratory abnormalities as assessed by CTCAE v5.0
Incidence of dose limiting toxicities (DLTs)
Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
Secondary outcome measures
Apparent plasma clearance (CL/F)
Apparent volume of distribution (Vd/F)
Area under the plasma concentration versus time curve (AUC)
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose escalation study of FT-7051Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,502 Previous Clinical Trials
2,384,337 Total Patients Enrolled
1 Trials studying Prostate Cancer
156 Patients Enrolled for Prostate Cancer
Forma Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
1,224 Total Patients Enrolled
Von Potter, MDStudy DirectorForma Therapeutics, Inc.
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

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

How has FT-7051 been evaluated for its safety profile?

"FT-7051 has not yet been thoroughly tested, so our team at Power gave it a safety score of 1. This is because Phase 1 trials only provide scant evidence regarding the efficacy and risk profile of this medication."

Answered by AI

Is the scope of this clinical trial confined to North America, or is it more expansive?

"Currently, this medical trial is enrolling patients from 8 geographically dispersed locations. These include Saint Louis, New york and Durham with the other 5 located elsewhere. To reduce travel demands for participants it may be beneficial to select a site nearest you if deciding to join in on the study."

Answered by AI

Are there any open enrollment opportunities for this research endeavor?

"Correct. Records hosted on clinicaltrials.gov demonstrate that this research is presently enrolling participants, which were initially posted on December 30th 2020 and was last modified on May 12th 2022. A total of 45 patients need to be recruited from 8 separate medical facilities."

Answered by AI

What is the cap on enrollment for this research endeavor?

"Forma Therapeutics, Inc. is the sponsor of this trial and requires 45 participants that meet the criteria to complete it. The research will take place in Washington University School of Medicine (St Louis, Missouri) and Icahn School of Medicine at Mt Sinai (New york City)."

Answered by AI
~6 spots leftby Mar 2025