Trials / Withdrawn
WithdrawnNCT04984330
Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease
- Status
- Withdrawn
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Weill Medical College of Cornell University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the safety and efficacy of Selinexor and Dexamethasone and see what effects it has on AL amyloidosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selinexor | Selinexor will be given orally at a dose of 60mg once weekly on the first day of the week (day 1, 8, 15, and 22) for Cycle 1 and up to Cycle 12. |
| DRUG | Dexamethasone | Dexamethasone will be given orally at a dose of 20mg, if tolerated, or at a reduced dose if required, 30 to 60 minutes prior to selinexor for first 2 days of each week only (days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle). |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2023-06-01
- Completion
- 2024-06-01
- First posted
- 2021-07-30
- Last updated
- 2022-11-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04984330. Inclusion in this directory is not an endorsement.