A Study of FT-7051 in Men With MCRPC

Metastatic Castration-resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04575766
• Other study ID #: 7051-ONC-101
• Status: Terminated
• Phase: Phase 1
• Start date: December 30, 2020
• Est. completion date: November 15, 2022

Study information

• Verified date: March 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 15, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Health	Aurora	Colorado
United States	University of Maryland, Greenebaum Cancer Center	Baltimore	Maryland
United States	Robert H. Lurie Comprehensive Cancer Center of Northwestern University	Chicago	Illinois
United States	Duke University Health System	Durham	North Carolina
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	HonorHealth	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose limiting toxicities (DLTs)		Within first 4 weeks of treatment
Primary	Serious adverse events (SAEs) and clinically relevant adverse events (AEs)		The treatment duration, predicted average 26 weeks
Primary	Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0		The treatment duration, predicted average 26 weeks
Secondary	Prostate-specific antigen (PSA): Percent Change from Baseline		12 weeks
Secondary	Prostate-specific antigen (PSA): Maximum Decrease from Baseline		The treatment duration, predicted average 26 weeks
Secondary	Prostate-specific antigen (PSA): Time to Progression		The treatment duration, predicted average 26 weeks
Secondary	Time to radiographic progression (rTTP)		The treatment duration, predicted average 26 weeks
Secondary	Overall response rate: radiographic response rate		The treatment duration, predicted average 26 weeks
Secondary	Complete response rate		The treatment duration, predicted average 26 weeks
Secondary	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
Secondary	Peak Plasma Concentration (Cmax)		Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Secondary	Time of peak plasma concentration (Tmax)		Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Secondary	Terminal elimination half-life (T 1/2)		Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Secondary	Apparent plasma clearance (CL/F)		Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Secondary	Apparent volume of distribution (Vd/F)		Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Secondary	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