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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Metastatic Castration-resistant Prostate Cancer

Clinical Trials on FT-7051

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings