Phase I Clinical Study of Oral TG02 Capsule in the Treatment of Recurrent / Progressive High-grade Glioma Patients
- Conditions
- High-grade Gliomas
- Interventions
- Drug: TG02 capsules oral administration, BIW in every 28d
- Registration Number
- NCT03904628
- Lead Sponsor
- Lee's Pharmaceutical Limited
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 150 mg, BIW in every 28d TG02 capsules oral administration, BIW in every 28d TG02 capsules were given orally at 150 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days. 250 mg, BIW in every 28d TG02 capsules oral administration, BIW in every 28d TG02 capsules were given orally at 250 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days. 200 mg, BIW in every 28d TG02 capsules oral administration, BIW in every 28d TG02 capsules were given orally at 200 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days.
- Primary Outcome Measures
Name Time Method Dose limiting toxicity (DLT) 28 days after first dose Adverse events of level 3 or above related to the study drug occurring within 28 days after the first dose as assessed by CTCAE v5.0.
Maximal tolerable dose(MTD) 28 days after first dose DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.
- Secondary Outcome Measures
Name Time Method Overall response rate（ORR） 12 months proportion of patients whose best overall response during their participation in the study is either CR or PR. The best overall response is the best response recorded from first dose until disease progression.
Trial Locations
- Locations (1)
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China