Clinical Trials /

A Study of FT-7051 in Men With MCRPC

NCT04575766

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of FT-7051 in Men With MCRPC
  • Official Title: A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 7051-ONC-101
  • NCT ID: NCT04575766

Conditions

  • Metastatic Castration-resistant Prostate Cancer

Interventions

DrugSynonymsArms
FT-7051Dose escalation study of FT-7051

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose escalation study of FT-7051Experimental
  • FT-7051

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose limiting toxicities (DLTs)
Time Frame:Within first 4 weeks of treatment
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Prostate-specific antigen (PSA): Percent Change from Baseline
Time Frame:12 weeks
Safety Issue:
Description:
Measure:Prostate-specific antigen (PSA): Maximum Decrease from Baseline
Time Frame:The treatment duration, predicted average 26 weeks
Safety Issue:
Description:
Measure:Prostate-specific antigen (PSA): Time to Progression
Time Frame:The treatment duration, predicted average 26 weeks
Safety Issue:
Description:
Measure:Time to radiographic progression (rTTP)
Time Frame:The treatment duration, predicted average 26 weeks
Safety Issue:
Description:
Measure:Overall response rate: radiographic response rate
Time Frame:The treatment duration, predicted average 26 weeks
Safety Issue:
Description:
Measure:Complete response rate
Time Frame:The treatment duration, predicted average 26 weeks
Safety Issue:
Description:
Measure:Area under the plasma concentration versus time curve (AUC)
Time Frame:Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Safety Issue:
Description:
Measure:Peak Plasma Concentration (Cmax)
Time Frame:Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Safety Issue:
Description:
Measure:Time of peak plasma concentration (Tmax)
Time Frame:Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Safety Issue:
Description:
Measure:Terminal elimination half-life (T 1/2)
Time Frame:Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Safety Issue:
Description:
Measure:Apparent plasma clearance (CL/F)
Time Frame:Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Safety Issue:
Description:
Measure:Apparent volume of distribution (Vd/F)
Time Frame:Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Safety Issue:
Description:
Measure:Model-based estimate of change from baseline QT interval corrected using Fridericia's correction formula (QTcF) and 90% confidence interval at the estimated Cmax
Time Frame:Electrocardiogram collected at multiple timepoints during the first 45 days of treatment
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Forma Therapeutics, Inc.

Trial Keywords

  • Metastatic Castration-resistant Prostate Cancer
  • Prostate cancer
  • Urogenital disease
  • Prostatic disease
  • Hormone antagonists
  • Hormones, hormone substitutes
  • FT-7051

Last Updated

October 28, 2020