Trials / Terminated
TerminatedNCT04575766
A Study of FT-7051 in Men With MCRPC
A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-12-30
- Primary completion
- 2022-11-08
- Completion
- 2022-11-15
- First posted
- 2020-10-05
- Last updated
- 2023-08-09
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04575766. Inclusion in this directory is not an endorsement.