A Study of FT-7051 in Men With MCRPC

NCT04575766 | Terminated Phase 1 FDA Drug

• 1 other identifier: 7051-ONC-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (3)

• Incidence of dose limiting toxicities (DLTs)

  Within first 4 weeks of treatment

• Serious adverse events (SAEs) and clinically relevant adverse events (AEs)

  The treatment duration, predicted average 26 weeks

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

  The treatment duration, predicted average 26 weeks

Secondary Outcomes (13)

• Prostate-specific antigen (PSA): Percent Change from Baseline

  12 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

• Time to radiographic progression (rTTP)

  The treatment duration, predicted average 26 weeks

• Overall response rate: radiographic response rate

  The treatment duration, predicted average 26 weeks

Study Arms (1)

Dose escalation study of FT-7051

EXPERIMENTAL

Drug: FT-7051

Interventions

FT-7051 DRUG

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.

Dose escalation study of FT-7051

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (8)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

University of Colorado Health

Aurora, Colorado, 80045, United States

Location

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Maryland, Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Related Publications (1)

• Caligiuri M, Williams GL, Castro J, Battalagine L, Wilker E, Yao L, Schiller S, Toms A, Li P, Pardo E, Graves B, Azofeifa J, Chicas A, Herbertz T, Lai M, Basken J, Wood KW, Xu Q, Guichard SM. FT-6876, a Potent and Selective Inhibitor of CBP/p300, is Active in Preclinical Models of Androgen Receptor-Positive Breast Cancer. Target Oncol. 2023 Mar;18(2):269-285. doi: 10.1007/s11523-023-00949-7. Epub 2023 Feb 24.

  PMID: 36826464 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Urogenital Diseases; Prostatic Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases

Study Officials

• Emma Barrett, MD

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 5, 2020
• Study Start: December 30, 2020
• Primary Completion: November 8, 2022
• Study Completion: November 15, 2022
• Last Updated: August 9, 2023

Record last verified: 2023-03

Locations

US (8)