NCT03904628

Phase I Clinical Study of Oral TG02 Capsule in the Treatment of Recurrent / Progressive High-grade Glioma Patients

Single-center, Dose Escalation, Open Phase I Clinical Study of Oral TG02 Capsule in the Treatment of Recurrent / Progressive High-grade Glioma Patients With Failed TMZ Treatment

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study was to explore the dose-limiting toxicity (DLT) and the maximum tolerable dose (MTD) of oral administration of TG02 capsules twice a week for 4 weeks.

Detailed description

Using the traditional 3 +3 design, 150 mg as the initial dose and 50 mg as the increasing interval of up to 250 mg, and oral administration on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day of each 28-day cycle. Phase I clinical study to evaluate the tolerance and pharmacokinetic parameters of oral TG02 capsules.

Conditions

• High-grade Gliomas

Interventions

Type	Name	Description
DRUG	TG02 capsules oral administration, BIW in every 28d	TG02 capsules150mg oral administration, BIW in every 28d
DRUG	TG02 capsules oral administration, BIW in every 28d	TG02 capsules 200mg oral administration, BIW in every 28d
DRUG	TG02 capsules oral administration, BIW in every 28d	TG02 capsules 250mg oral administration, BIW in every 28d

Timeline

• Start date: 2019-03-22
• Primary completion: 2020-08-01
• Completion: 2020-10-31
• First posted: 2019-04-05
• Last updated: 2020-04-14

Locations

1 site across 1 country: China