Trials / Unknown
UnknownNCT02650375
Study of Metatinib Tromethamine Tablet
A Phase Ib Clinical Study of the Tolerance, Safety and Preliminary Efficacy Observation of Single-/Multiple- Doses of Metatinib Tromethamine Tablets in Patients With Advanced or Metastatic Solid Tumor
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, multicenter study designed to assess the safety, tolerability, preliminary efficacy and pharmacokinetics of Metatinib Tromethamine tablet in patients with advanced or metastatic gastric cancer, liver cancer, colorectal cancer,or con squamous NSCLC. Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred. The study will determine whether MET gene mutation, amplification, as well as MET protein overexpression in tumor tissue correlate with treatment efficacy and clinical outcome. The potential PD biomarker for Metatinib will also be explored.
Conditions
- Advanced or Metastatic Gastric Cancer
- Advanced or Metastatic Liver Cancer
- Advanced or Metastatic CRC
- Advanced or Metastatic Non Squamous NSCLC
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Metatinib Tromethamine | Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-10-01
- Completion
- 2018-02-01
- First posted
- 2016-01-08
- Last updated
- 2017-01-23
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02650375. Inclusion in this directory is not an endorsement.