Clinical trial NCT04575766: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: Metastatic Castration-resistant Prostate Cancer
Prostate cancer
Urogenital disease
Prostatic disease
Hormone antagonists
Hormones, hormone substitutes
FT-7051
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of dose limiting toxicities (DLTs)
timeFrame: Within first 4 weeks of treatment
measure: Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
timeFrame: The treatment duration, predicted average 26 weeks
measure: Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0
timeFrame: The treatment duration, predicted average 26 weeks
Secondary outcomes:
measure: Prostate-specific antigen (PSA): Percent Change from Baseline
timeFrame: 12 weeks
measure: Prostate-specific antigen (PSA): Maximum Decrease from Baseline
timeFrame: The treatment duration, predicted average 26 weeks
measure: Prostate-specific antigen (PSA): Time to Progression
timeFrame: The treatment duration, predicted average 26 weeks
measure: Time to radiographic progression (rTTP)
timeFrame: The treatment duration, predicted average 26 weeks
measure: Overall response rate: radiographic response rate
timeFrame: The treatment duration, predicted average 26 weeks
measure: Complete response rate
timeFrame: The treatment duration, predicted average 26 weeks
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
measure: Peak Plasma Concentration (Cmax)
timeFrame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
measure: Time of peak plasma concentration (Tmax)
timeFrame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
measure: Terminal elimination half-life (T 1/2)
timeFrame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
measure: Apparent plasma clearance (CL/F)
timeFrame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
measure: Apparent volume of distribution (Vd/F)
timeFrame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
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
timeFrame: Electrocardiogram collected at multiple timepoints during the first 45 days of treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Health
state: Colorado
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland, Greenebaum Cancer Center
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
Study officials:
affiliation: Novo Nordisk A/S
name: Emma Barrett, MD
role: STUDY_DIRECTOR
References: