Trials / Terminated
TerminatedNCT03768505
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 169 (actual)
- Sponsor
- MEI Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy
Detailed description
This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue. Approximately 180 subjects will be enrolled and treated with Zandelisib (ME-401) on the intermittent schedule.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zandelisib (ME-401) | Zandelisib (ME-401) 60 mg |
Timeline
- Start date
- 2019-06-25
- Primary completion
- 2023-03-24
- Completion
- 2023-03-24
- First posted
- 2018-12-07
- Last updated
- 2024-12-31
- Results posted
- 2024-02-01
Locations
115 sites across 14 countries: United States, Australia, Austria, Belgium, France, Germany, Italy, New Zealand, Poland, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03768505. Inclusion in this directory is not an endorsement.