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

Novo Nordisk A/S8 sites in 1 country25 target enrollmentDecember 30, 2020

ConditionsMetastatic Castration-resistant Prostate Cancer

InterventionsFT-7051

DrugsFT-7051

Overview

Phase: Phase 1
Intervention: FT-7051
Conditions: Metastatic Castration-resistant Prostate Cancer
Sponsor: Novo Nordisk A/S
Enrollment: 25
Locations: 8
Primary Endpoint: Incidence of dose limiting toxicities (DLTs)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 30, 2020

End Date

November 15, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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)

Arms & Interventions

Dose escalation study of FT-7051

Intervention: FT-7051

Outcomes

Primary Outcomes

Incidence of dose limiting toxicities (DLTs)

Time Frame: 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

Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0

Time Frame: The treatment duration, predicted average 26 weeks

Secondary Outcomes

Time to radiographic progression (rTTP)(The treatment duration, predicted average 26 weeks)
Prostate-specific antigen (PSA): Maximum Decrease from Baseline(The treatment duration, predicted average 26 weeks)
Prostate-specific antigen (PSA): Time to Progression(The treatment duration, predicted average 26 weeks)
Apparent plasma clearance (CL/F)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
Apparent volume of distribution (Vd/F)(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(Electrocardiogram collected at multiple timepoints during the first 45 days of treatment)
Overall response rate: radiographic response rate(The treatment duration, predicted average 26 weeks)
Complete response rate(The treatment duration, predicted average 26 weeks)
Area under the plasma concentration versus time curve (AUC)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
Prostate-specific antigen (PSA): Percent Change from Baseline(12 weeks)
Peak Plasma Concentration (Cmax)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
Time of peak plasma concentration (Tmax)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)
Terminal elimination half-life (T 1/2)(Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment)