Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
7051-ONC-101
- NCT ID:
NCT04575766
Conditions
- Metastatic Castration-resistant Prostate Cancer
Interventions
Drug | Synonyms | Arms |
---|
FT-7051 | | Dose escalation study of FT-7051 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose escalation study of FT-7051 | Experimental | | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of dose limiting toxicities (DLTs) |
Time Frame: | Within first 4 weeks of treatment |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Prostate-specific antigen (PSA): Percent Change from Baseline |
Time Frame: | 12 weeks |
Safety Issue: | |
Description: | |
Measure: | Prostate-specific antigen (PSA): Maximum Decrease from Baseline |
Time Frame: | The treatment duration, predicted average 26 weeks |
Safety Issue: | |
Description: | |
Measure: | Prostate-specific antigen (PSA): Time to Progression |
Time Frame: | The treatment duration, predicted average 26 weeks |
Safety Issue: | |
Description: | |
Measure: | Time to radiographic progression (rTTP) |
Time Frame: | The treatment duration, predicted average 26 weeks |
Safety Issue: | |
Description: | |
Measure: | Overall response rate: radiographic response rate |
Time Frame: | The treatment duration, predicted average 26 weeks |
Safety Issue: | |
Description: | |
Measure: | Complete response rate |
Time Frame: | The treatment duration, predicted average 26 weeks |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Peak Plasma Concentration (Cmax) |
Time Frame: | Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment |
Safety Issue: | |
Description: | |
Measure: | Time of peak plasma concentration (Tmax) |
Time Frame: | Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Apparent plasma clearance (CL/F) |
Time Frame: | Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment |
Safety Issue: | |
Description: | |
Measure: | Apparent volume of distribution (Vd/F) |
Time Frame: | Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment |
Safety Issue: | |
Description: | |
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 |
Time Frame: | Electrocardiogram collected at multiple timepoints during the first 45 days of treatment |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Forma Therapeutics, Inc. |
Trial Keywords
- Metastatic Castration-resistant Prostate Cancer
- Prostate cancer
- Urogenital disease
- Prostatic disease
- Hormone antagonists
- Hormones, hormone substitutes
- FT-7051
Last Updated
July 16, 2021