A Study of FT-7051 in Men With MCRPC

  • STATUS
    Recruiting
  • End date
    Mar 29, 2023
  • participants needed
    45
  • sponsor
    Forma Therapeutics, Inc.
Updated on 29 May 2022
Investigator
Jill Harper, RN, PhD
Primary Contact
University of Maryland, Greenebaum Cancer Center (7.8 mi away) Contact
+7 other location

Summary

This is a Phase 1, open-label study that will evaluate the safety and tolerability of FT-7051 and determine the recommended Phase 2 dose (RP2D) as well as pharmacokinetics (PK), preliminary anti-tumor activity, and pharmacodynamics (PD) of FT-7051 in men with metastatic castration-resistant prostate cancer who have progressed despite prior therapy and had been treated with at least one potent anti-androgen therapy.

The starting dose, 25 mg once daily (QD), of FT-7051 administered discontinuously (21 days on/7 days off) in 28-day cycles.

Details
Condition Metastatic Castration-resistant Prostate Cancer
Treatment FT-7051
Clinical Study IdentifierNCT04575766
SponsorForma Therapeutics, Inc.
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent
Diagnosis of progressive metastatic castration-resistant prostate cancer (mCRPC)
Previously failed at least one potent anti-androgen therapy
Castrate levels of serum testosterone
ECOG performance status 0-2
Adequate bone marrow function
Adequate kidney, heart and liver function

Exclusion Criteria

Prior solid organ transplant
Prior treatment with small molecules including chemotherapy, antibody, or other experimental anticancer therapeutic within 4 weeks of first dose of study treatment
Prior radiation therapy within 4 weeks prior to initiation of study treatment (including radiofrequency ablation)
Prior androgen antagonist therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide) within 2 weeks
Prior radium-223 therapy within 6 weeks
Symptomatic, untreated or actively progressing central nervous system (CNS) metastasis
Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes, active or uncontrolled infection requiring systemic therapy) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgement, increase the risk to the patient associated with participation in the study
Concomitant medications that cause Torsades de Pointes that have not reached steady state before first dose of the study drug
Concomitant medications that are strong inhibitors or inducers of CYP3A4 or an inhibitor of P-gp
History of infection with human immunodeficiency virus (HIV)
Active infection with hepatitis B, or hepatitis C virus
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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