Metastatic Castration-resistant Prostate CancerPhase 1NCT04575766
A Study of FT-7051 in Men With MCRPC
A Phase 1 study testing FT-7051 in people with Metastatic Castration-resistant Prostate Cancer, run by Novo Nordisk A/S at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- FT-7051
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Dec 2020to 15 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Colorado Health
Aurora, Colorado, 80045
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
Duke University Health System
Durham, North Carolina, 27710
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
HonorHealth
Scottsdale, Arizona, 85258
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer
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.
- Being tested
- FT-7051
- Keywords
- Metastatic Castration-resistant Prostate Cancer, Prostate cancer, Urogenital disease, Prostatic disease, Hormone antagonists, Hormones, hormone substitutes, FT-7051
- Medical subject headings
- Prostatic Neoplasms, Urogenital Diseases, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT-7051Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation study of FT-7051 | Experimental | Not described Receives: Drug: FT-7051 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
Measured: Within first 4 weeks of treatment
Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
Measured: The treatment duration, predicted average 26 weeks
Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0
Measured: The treatment duration, predicted average 26 weeks
Secondary outcomes (13)
Prostate-specific antigen (PSA): Percent Change from Baseline
Measured: 12 weeks
Prostate-specific antigen (PSA): Maximum Decrease from Baseline
Measured: The treatment duration, predicted average 26 weeks
Prostate-specific antigen (PSA): Time to Progression
Measured: The treatment duration, predicted average 26 weeks
Time to radiographic progression (rTTP)
Measured: The treatment duration, predicted average 26 weeks
Overall response rate: radiographic response rate
Measured: The treatment duration, predicted average 26 weeks
Complete response rate
Measured: The treatment duration, predicted average 26 weeks
Area under the plasma concentration versus time curve (AUC)
Measured: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Peak Plasma Concentration (Cmax)
Measured: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Time of peak plasma concentration (Tmax)
Measured: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Terminal elimination half-life (T 1/2)
Measured: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Apparent plasma clearance (CL/F)
Measured: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Apparent volume of distribution (Vd/F)
Measured: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Model-based estimate of change from baseline QT interval corrected using Fridericia's correction formula (QTcF) and 90% confidence interval at the estimated Cmax
Measured: Electrocardiogram collected at multiple timepoints during the first 45 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start30 Dec 2020
- Primary completion8 Nov 2022
- Study completion15 Nov 2022
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Barrett, MD, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575766
- Sponsor's protocol ID
- 7051-ONC-101
- Status last verified
- Mar 2023
- First submitted
- 24 Sep 2020
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 36826464
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04575766
- Acronym / sponsor ID
- 7051-ONC-101
- Keywords
- Metastatic Castration-resistant Prostate Cancer, Prostate cancer, Urogenital disease, Prostatic disease, Hormone antagonists, Hormones, hormone substitutes, FT-7051
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalation study of FT-7051 | Experimental | Drug: FT-7051 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT-7051Dose 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. | Drug | Dose escalation study of FT-7051 |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: Within first 4 weeks of treatment
Serious adverse events (SAEs) and clinically relevant adverse events (AEs)
Time frame: The treatment duration, predicted average 26 weeks
Incidence of clinical laboratory abnormalities as assessed by CTCAE v5.0
Time frame: The treatment duration, predicted average 26 weeks
13 secondary outcomes
Prostate-specific antigen (PSA): Percent Change from Baseline
Time frame: 12 weeks
Prostate-specific antigen (PSA): Maximum Decrease from Baseline
Time frame: The treatment duration, predicted average 26 weeks
Prostate-specific antigen (PSA): Time to Progression
Time frame: The treatment duration, predicted average 26 weeks
Time to radiographic progression (rTTP)
Time frame: The treatment duration, predicted average 26 weeks
Overall response rate: radiographic response rate
Time frame: The treatment duration, predicted average 26 weeks
Complete response rate
Time frame: The treatment duration, predicted average 26 weeks
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
Peak Plasma Concentration (Cmax)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Time of peak plasma concentration (Tmax)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
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
Apparent plasma clearance (CL/F)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
Apparent volume of distribution (Vd/F)
Time frame: Blood samples for PK analysis collected at multiple visits during the first 90 days of treatment
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
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Derived from this study: PubMed 36826464Caligiuri 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.
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NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Barrett, MD study director
Novo Nordisk A/S
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT-7051 in people with Metastatic Castration-resistant Prostate Cancer, run by Novo Nordisk A/S at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (DLTs) (time frame: Within first 4 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.