Back to resultsA Study of FT-7051 in Men With MCRPC
Primary Purpose
Metastatic Castration-resistant Prostate Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FT-7051
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring Metastatic Castration-resistant Prostate Cancer, Prostate cancer, Urogenital disease, Prostatic disease, Hormone antagonists, Hormones, hormone substitutes, FT-7051
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
Sites / Locations
- HonorHealth
- University of Colorado Health
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
- University of Maryland, Greenebaum Cancer Center
- Washington University School of Medicine
- Icahn School of Medicine at Mt. Sinai
- Duke University Health System
- Carolina Urologic Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose escalation study of FT-7051
Arm Description
Outcomes
Primary Outcome Measures
Incidence of dose limiting toxicities (DLTs)
Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0
Secondary Outcome Measures
Prostate-specific antigen (PSA): Percent Change from Baseline
Prostate-specific antigen (PSA): Maximum Decrease from Baseline
Prostate-specific antigen (PSA): Time to Progression
Time to radiographic progression (rTTP)
Overall response rate: radiographic response rate
Complete response rate
Area under the plasma concentration versus time curve (AUC)
Peak Plasma Concentration (Cmax)
Time of peak plasma concentration (Tmax)
Terminal elimination half-life (T 1/2)
Apparent plasma clearance (CL/F)
Apparent volume of distribution (Vd/F)
Model-based estimate of change from baseline QT interval corrected using Fridericia's correction formula (QTcF) and 90% confidence interval at the estimated Cmax
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04575766
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
December 30, 2020 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-resistant Prostate Cancer
Keywords
Metastatic Castration-resistant Prostate Cancer, Prostate cancer, Urogenital disease, Prostatic disease, Hormone antagonists, Hormones, hormone substitutes, FT-7051
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation study of FT-7051
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FT-7051
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of dose limiting toxicities (DLTs)
Time Frame
Within first 4 weeks of treatment
Title
Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
Time Frame
The treatment duration, predicted average 26 weeks
Title
Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0
Time Frame
The treatment duration, predicted average 26 weeks
Secondary Outcome Measure Information:
Title
Prostate-specific antigen (PSA): Percent Change from Baseline
Time Frame
12 weeks
Title
Prostate-specific antigen (PSA): Maximum Decrease from Baseline
Time Frame
The treatment duration, predicted average 26 weeks
Title
Prostate-specific antigen (PSA): Time to Progression
Time Frame
The treatment duration, predicted average 26 weeks
Title
Time to radiographic progression (rTTP)
Time Frame
The treatment duration, predicted average 26 weeks
Title
Overall response rate: radiographic response rate
Time Frame
The treatment duration, predicted average 26 weeks
Title
Complete response rate
Time Frame
The treatment duration, predicted average 26 weeks
Title
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
Title
Peak Plasma Concentration (Cmax)
Time Frame
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Title
Time of peak plasma concentration (Tmax)
Time Frame
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Title
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
Title
Apparent plasma clearance (CL/F)
Time Frame
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Title
Apparent volume of distribution (Vd/F)
Time Frame
Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Barrett, MD
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of Colorado Health
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland, Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Icahn School of Medicine at Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
12. IPD Sharing Statement
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A Study of FT-7051 in Men With MCRPC
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