A Study of FT-7051 in Men With MCRPC

August 8, 2023 updated by: Novo Nordisk A/S

A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Health
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mt. Sinai
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation study of FT-7051
Drug: FT-7051

Dose levels: Dose Level -1 through Dose Level 7, assigned per the protocol using a BOIN design. Additional dose levels may be explored as applicable.

Capsules available in strengths of 10mg, 25mg, and 100 mg that are orally administered per the protocol frequency and dose level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose limiting toxicities (DLTs)
Time Frame: Within first 4 weeks of treatment
Within first 4 weeks of treatment
Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
Time Frame: The treatment duration, predicted average 26 weeks
The treatment duration, predicted average 26 weeks
Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0
Time Frame: The treatment duration, predicted average 26 weeks
The treatment duration, predicted average 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Prostate-specific antigen (PSA): Percent Change from Baseline
Time Frame: 12 weeks
12 weeks
Prostate-specific antigen (PSA): Maximum Decrease from Baseline
Time Frame: The treatment duration, predicted average 26 weeks
The treatment duration, predicted average 26 weeks
Prostate-specific antigen (PSA): Time to Progression
Time Frame: The treatment duration, predicted average 26 weeks
The treatment duration, predicted average 26 weeks
Time to radiographic progression (rTTP)
Time Frame: The treatment duration, predicted average 26 weeks
The treatment duration, predicted average 26 weeks
Overall response rate: radiographic response rate
Time Frame: The treatment duration, predicted average 26 weeks
The treatment duration, predicted average 26 weeks
Complete response rate
Time Frame: The treatment duration, predicted average 26 weeks
The treatment duration, predicted average 26 weeks
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
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Peak Plasma Concentration (Cmax)
Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Time of peak plasma concentration (Tmax)
Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
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
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Apparent plasma clearance (CL/F)
Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Apparent volume of distribution (Vd/F)
Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
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
Electrocardiogram collected at multiple timepoints during the first 45 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Emma Barrett, MD, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2020

Primary Completion (Actual)

November 8, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7051-ONC-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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