Trials / Completed
CompletedNCT02004548
Phase I Clinical Study of Metatinib Tromethamine Tablet
A Phase I, Multiple Dose Escalation Clinical Trial of Metatinib Tromethamine Tablet in Patients With Advanced or Metastatic Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters. Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metatinib Tromethamine |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2015-09-01
- Completion
- 2015-12-01
- First posted
- 2013-12-09
- Last updated
- 2015-12-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02004548. Inclusion in this directory is not an endorsement.