NCT03231475

Phase I Study of SPH1188-11 in NSCLC

Phase I, Open-label Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of SPH1188-11 Tablets for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Detailed description

Phase I dose escalation study

Conditions

• NSCLC Stage IIIB
• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	SPH1188-11	qd.po

Timeline

• Start date: 2017-07-21
• Primary completion: 2020-12-31
• Completion: 2022-03-31
• First posted: 2017-07-27
• Last updated: 2021-11-08

Locations

1 site across 1 country: China