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
Overview
- Phase
- Phase 1
- Intervention
- TG02 capsules oral administration, BIW in every 28d
- Conditions
- High-grade Gliomas
- Sponsor
- Lee's Pharmaceutical Limited
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Dose limiting toxicity (DLT)
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
150 mg, 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.
Intervention: TG02 capsules oral administration, BIW in every 28d
200 mg, 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.
Intervention: TG02 capsules oral administration, BIW in every 28d
250 mg, 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.
Intervention: TG02 capsules oral administration, BIW in every 28d
Outcomes
Primary Outcomes
Dose limiting toxicity (DLT)
Time Frame: 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)
Time Frame: 28 days after first dose
DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.
Secondary Outcomes
- Overall response rate（ORR）(12 months)