Trials / Completed
CompletedNCT03770000
Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma
An Open Label, Phase I/II Study to Evaluate the Safety and Efficacy of Tenalisib (RP6530), a Novel PI3K δ/γ Dual Inhibitor Given in Combination With a Histone Deacetylase (HDAC) Inhibitor, Romidepsin in Adult Patients With Relapsed/Refractory T-cell Lymphoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Rhizen Pharmaceuticals SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To characterize safety, tolerability and to establish the maximum tolerated dose (MTD) of Tenalisib in combination with Romidepsin in patients with R/R T-cell lymphoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tenalisib | Tenalisib, BID orally daily |
| DRUG | Romidepsin | Romidepsin IV |
Timeline
- Start date
- 2019-03-12
- Primary completion
- 2021-05-14
- Completion
- 2021-05-14
- First posted
- 2018-12-10
- Last updated
- 2022-10-28
- Results posted
- 2022-10-28
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03770000. Inclusion in this directory is not an endorsement.