Trials / Completed
CompletedNCT03730142
A Study of WXFL10030390 in Patients With Advanced Solid Tumors or Lymphoma
A Phase Ⅰ Study of PI3K/mTOR Dual Inhibitor WXFL10030390 to Evaluate the Safety, Tolerability and Pharmacokinetics in Patients With Advanced Solid Tumors or Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
WXFL10030390 (WX390) is a novel oral small molecular that inhibits phosphoinositide-3 kinase (PI3K) and mammalian target of rapamycin (mTOR) and has demonstrated potent inhibitory effects on multiple human tumor xenografts. The first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of WX390 at single dose and multiple doses.
Detailed description
This study will be an open-lable, phase Ⅰ study and will evaluate the safety and pharmacokinetics of WX390 after a single administration followed by a 28-day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-lable administration of WX390 at the MTD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WXFL10030390 | WXFL10030390 is a tablet in the form of 0.1mg and 0.5mg, oral, once a day. |
Timeline
- Start date
- 2018-10-25
- Primary completion
- 2020-07-25
- Completion
- 2020-07-25
- First posted
- 2018-11-05
- Last updated
- 2023-04-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03730142. Inclusion in this directory is not an endorsement.