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A Study of FT-7051 in Men With MCRPC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04575766
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : May 16, 2022
Sponsor:
Information provided by (Responsible Party):
Forma Therapeutics, Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: FT-7051 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of dose limiting toxicities (DLTs) [ Time Frame: Within first 4 weeks of treatment ]
  2. Serious adverse events (SAEs) and clinically relevant adverse events (AEs) [ Time Frame: The treatment duration, predicted average 26 weeks ]
  3. Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0 [ Time Frame: The treatment duration, predicted average 26 weeks ]

Secondary Outcome Measures :
  1. Prostate-specific antigen (PSA): Percent Change from Baseline [ Time Frame: 12 weeks ]
  2. Prostate-specific antigen (PSA): Maximum Decrease from Baseline [ Time Frame: The treatment duration, predicted average 26 weeks ]
  3. Prostate-specific antigen (PSA): Time to Progression [ Time Frame: The treatment duration, predicted average 26 weeks ]
  4. Time to radiographic progression (rTTP) [ Time Frame: The treatment duration, predicted average 26 weeks ]
  5. Overall response rate: radiographic response rate [ Time Frame: The treatment duration, predicted average 26 weeks ]
  6. Complete response rate [ Time Frame: The treatment duration, predicted average 26 weeks ]
  7. 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 ]
  8. Peak Plasma Concentration (Cmax) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
  9. Time of peak plasma concentration (Tmax) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
  10. 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 ]
  11. Apparent plasma clearance (CL/F) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
  12. Apparent volume of distribution (Vd/F) [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment ]
  13. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575766


Contacts
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Contact: Forma Therapeutics 617-679-1970 medicalinformation@formatherapeutics.com

Locations
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United States, Arizona
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Sierra Bichler    480-323-1791    clinicaltrials@honorhealth.com   
United States, Colorado
University of Colorado Health Recruiting
Aurora, Colorado, United States, 80045
Contact: Jake Baldasare    720-848-9383    jake.baldasare@cuanschutz.edu   
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Morgan Whipkey    312-695-1301    RHLCCCEPTInquiries@northwestern.edu   
United States, Maryland
University of Maryland, Greenebaum Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jill Harper, PhD, RN    410-328-1160    jillharper@umm.edu   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Dave Timm    314-747-1343    timmd@wustl.edu   
United States, New York
Icahn School of Medicine at Mt. Sinai Recruiting
New York, New York, United States, 10029
Contact: Vibhaiv Patel    212-636-3856    vaibhav.patel@mountsinai.org   
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Julia Hurrelbrink, RN    919-681-7460    julia.hurrelbrink@duke.edu   
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Rebecca Floyd    843-449-1010    rfloyd@curcmb.com   
Sponsors and Collaborators
Forma Therapeutics, Inc.
Investigators
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Study Director: Von Potter, MD Forma Therapeutics, Inc.
More Information
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Responsible Party: Forma Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04575766    
Other Study ID Numbers: 7051-ONC-101
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Forma Therapeutics, Inc.:
Metastatic Castration-resistant Prostate Cancer
Prostate cancer
Urogenital disease
Prostatic disease
 Hormone antagonists
Hormones, hormone substitutes
FT-7051
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases