Trials / Unknown
UnknownNCT04431089
Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma
A Phase II Multicenter Study to Investigate the Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients with relapsed or refractory relapsed or refractory follicular (FL) or marginal one (MZL) lymphoma.
Detailed description
This is a phase II, multicenter study to assess the efficacy and safety of SHC014748M, an oral inhibitor of PI3K delta, in patients with relapsed or refractory relapsed or refractory follicular (FL) or marginal one (MZL) lymphoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHC014748M | Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28). Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable. |
Timeline
- Start date
- 2020-05-09
- Primary completion
- 2021-04-01
- Completion
- 2021-07-01
- First posted
- 2020-06-16
- Last updated
- 2021-01-28
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04431089. Inclusion in this directory is not an endorsement.