Trials / Terminated
TerminatedNCT03935555
Assess the Safety, Tolerability Oral PU-H71 in Subjects Taking Ruxolitinib
Phase 1b Study of PU-H71 for the Treatment of Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), Treated With Ruxolitinib
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Samus Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, Phase 1b study with dose escalation and expansion cohorts designed to assess the safety, tolerability, PK, and preliminary efficacy of PU-H71 in subjects with PMF, Post-PV MF, Post-ET MF, taking stable doses of ruxolitinib.
Detailed description
The study will employ a standard 3+3 dose escalation design to determine maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), with additional subjects treated in a dose expansion cohort. The time period for collecting dose limiting toxicities (DLTs) is 1 cycle (21 days).
Conditions
- Primary Myelofibrosis (PMF)
- Post-Polycythemia Vera Myelofibrosis (Post-PV MF)
- Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PU-H71 | PU-H71 is a synthetic purine-scaffold stress chaperome inhibitor, which specifically targets HSP90 in the tumor-specific epichaperome |
Timeline
- Start date
- 2019-08-12
- Primary completion
- 2022-10-19
- Completion
- 2022-11-04
- First posted
- 2019-05-02
- Last updated
- 2022-11-17
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03935555. Inclusion in this directory is not an endorsement.