Trials / Terminated
TerminatedNCT05382936
Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors
A Phase 1, Open-label, Dose-escalation Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Stemline Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study STML-901-0119 was a dose-escalation study evaluating multiple doses and schedules of orally administered SL-901 in patients with advanced solid tumors.
Detailed description
Study STML-901-0119 was a multi-center, open-label, dose-escalation, and regimen-finding study aimed to investigate the safety, pharmacokinetics (PK), and pharmacodynamics of SL-901 in patients with advanced solid tumors. This study initially included two parts: Part 1a, which used a 3+3 dose-escalation design to determine the maximum tolerated dose and an appropriate dosing regimen of SL-901 when administered on both once-daily (QD) and twice-daily (BID) schedules; Part 1b, which was intended to evaluate the clinical activity of SL-901 at the selected dose in patients with advanced solid tumors with specific genetic alterations. The study was stopped after careful consideration of the landscape of similar drugs and evolving standard of care. As a result, Part 1b was not initiated. In Part 1a, eligible patients were enrolled to receive SL-901 orally on a 28-day cycle. Study enrollment was conducted in 2 centers in the United Kingdom, and patients were assigned to either the QD or BID dosing regimen based on their cohort assignment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SL-901 | Patients took study medication daily, with dosage based on their assigned cohort and regimen. |
Timeline
- Start date
- 2021-03-19
- Primary completion
- 2023-05-05
- Completion
- 2023-05-05
- First posted
- 2022-05-19
- Last updated
- 2025-01-09
- Results posted
- 2025-01-09
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05382936. Inclusion in this directory is not an endorsement.