High-grade GliomasPhase 1NCT03904628
Phase I Clinical Study of Oral TG02 Capsule in the Treatment of Recurrent / Progressive High-grade Glioma Patients
A Phase 1 study testing TG02 capsules oral administration, BIW in every 28d in people with High-grade Gliomas, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High-grade Gliomas
- What is being tested?
- TG02 capsules oral administration, BIW in every 28d
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2019to 31 Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 ~ 75 years old, both men and women.
- Histologically proven glioblastoma or anaplastic astrocytoma that has failed from temozolomide treatment in the past.
- According to RANO criteria, patients with clinically evaluated recurrence or progression with clearly measurable lesions.
- If previous radiotherapy has been performed, it must be completed for a period of more than 3 months, or within 3 months but tumor progression occurs in the original radiation field or has been confirmed by histopathology. .
- The first day of treatment was ≥ 2 weeks from the second surgery of recurrence, and the incision is healed in grade A.
- ECOG 0 - 2 points, can swallow the drug and maintain oral administration.
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- The expected survival time was more than 3 months.
- The hematopoietic function of bone marrow was adequate: ANC≥1.5×109/L，PLT≥100×109/L，Hb≥90 g/L；.
- Patients who had previously undergone surgical resection were able to provide no less than 15 tumor tissue sections and pathological reports for the study.
Who cannot join
- Other cytotoxic drugs were received within 28 days prior to the start of the study, or adverse reactions from previous systematic treatment have not recovered (except alopecia and pigmentation).
- Bevacizumab was treated within 6 weeks before the start of the study.
- Previous treatment with carmostine sustained-release implants or intracerebral implantation of radiotherapy.
- A patient with a major seizure that cannot be effectively controlled by drugs.
- MRI examinations cannot be performed (e.g. pacemakers, undesirable metal dentures, etc.).
- Patients with severe impairment of liver and kidney function: ALT ≥ 2.5 ULN,AST ≥ 2.5 ULN in patients without liver metastasis; ALT ≥ 5 ULN,AST ≥ 5 ULN in patients with liver metastasis; Or TBIL ≥ 1.5 ULN, or Cr ≥ 1.5 ULN, or creatinine clearance ≤ 60 ml/ min calculated by Cockcroft-Gault formula;
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- Unstable or uncontrollable diseases or conditions related to or affecting cardiac function (e.g. unstable angina pectoris, congestive heart failure [NYHA > II], uncontrolled hypertension [diastolic blood pressure > 85 mmHg; systolic blood pressure >145 mmHg]), arrhythmia or prolonged QTc interval (male > 450 Ms; female > 470ms).
- A history of arterial thromboembolism (such as stroke, transient ischemic attack, or myocardial infarction) within 6 months. Bleeding or hypercoagulable coagulation disorder occurred within 6 months prior to the first day of the study.
- Active peptic ulcer or inflammatory bowel disease.
- Active hepatitis, or HIV, Treponema pallidum infection.
- Pregnant or breastfeeding.
- Subjects who were unable to use adequate contraception during the study and for six months after the end of the study were unable to use adequate contraception.
- Currently participating in another clinical trial or within 30 days of the last administration of the trial drug.
- The subjects had conditions that affected their provision of written informed consent and / or compliance with the research process.
- There were cases in which any other investigator did not consider it appropriate to join the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
Zhongping Chen, doctor, +8613500002457, chenzhp@sysucc.org.cn
Zhengzheng Guo, doctor, +8613580332120, guochch@sysucc.org.cn
About this study
Official title: 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
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.
Read the 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
- Being tested
- TG02 capsules oral administration, BIW in every 28d
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG02 capsules oral administration, BIW in every 28dDrug
TG02 capsules150mg oral administration, BIW in every 28d
TG02 capsules oral administration, BIW in every 28dDrug
TG02 capsules 200mg oral administration, BIW in every 28d
TG02 capsules oral administration, BIW in every 28dDrug
TG02 capsules 250mg oral administration, BIW in every 28d
| Study group | Role | What they receive |
|---|---|---|
| 150 mg, BIW in every 28d | Experimental | TG02 capsules were given orally at 150 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days. Receives: Drug: TG02 capsules oral administration, BIW in every 28d |
| 200 mg, BIW in every 28d | Experimental | TG02 capsules were given orally at 200 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days. Receives: Drug: TG02 capsules oral administration, BIW in every 28d |
| 250 mg, BIW in every 28d | Experimental | TG02 capsules were given orally at 250 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days. Receives: Drug: TG02 capsules oral administration, BIW in every 28d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
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.
Measured: 28 days after first dose
Maximal tolerable dose(MTD)
DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.
Measured: 28 days after first dose
Secondary outcomes (1)
Overall response rate（ORR）
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start22 Mar 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade GliomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904628
- Sponsor's protocol ID
- NTL-LEES-2018-02
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03904628
- Acronym / sponsor ID
- NTL-LEES-2018-02
- Conditions
- High-grade Gliomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150 mg, BIW in every 28d | Experimental | Drug: TG02 capsules oral administration, BIW in every 28dTG02 capsules were given orally at 150 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days. |
| 200 mg, BIW in every 28d | Experimental | Drug: TG02 capsules oral administration, BIW in every 28dTG02 capsules were given orally at 200 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days. |
| 250 mg, BIW in every 28d | Experimental | Drug: TG02 capsules oral administration, BIW in every 28dTG02 capsules were given orally at 250 mg on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day, every 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18 ~ 75 years old, both men and women.
- Histologically proven glioblastoma or anaplastic astrocytoma that has failed from temozolomide treatment in the past.
- According to RANO criteria, patients with clinically evaluated recurrence or progression with clearly measurable lesions.
- If previous radiotherapy has been performed, it must be completed for a period of more than 3 months, or within 3 months but tumor progression occurs in the original radiation field or has been confirmed by histopathology. .
- The first day of treatment was ≥ 2 weeks from the second surgery of recurrence, and the incision is healed in grade A.
Key exclusion criteria (15 listed)
- Other cytotoxic drugs were received within 28 days prior to the start of the study, or adverse reactions from previous systematic treatment have not recovered (except alopecia and pigmentation).
- Bevacizumab was treated within 6 weeks before the start of the study.
- Previous treatment with carmostine sustained-release implants or intracerebral implantation of radiotherapy.
- A patient with a major seizure that cannot be effectively controlled by drugs.
- MRI examinations cannot be performed (e.g. pacemakers, undesirable metal dentures, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG02 capsules oral administration, BIW in every 28dTG02 capsules150mg oral administration, BIW in every 28d | Drug | 150 mg, BIW in every 28d |
| TG02 capsules oral administration, BIW in every 28dTG02 capsules 200mg oral administration, BIW in every 28d | Drug | 200 mg, BIW in every 28d |
| TG02 capsules oral administration, BIW in every 28dTG02 capsules 250mg oral administration, BIW in every 28d | Drug | 250 mg, BIW in every 28d |
Primary outcome
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.
1 secondary outcome
Overall response rate（ORR）
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TG02 capsules oral administration, BIW in every 28d in people with High-grade Gliomas, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongping Chen, doctor (+8613500002457, chenzhp@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 28 days after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.