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The goal of this clinical trial is to evaluate the safety and efficacy of PLB1001 Enteric Capsules in the treatment of PTPRZ1-MET fusion gene positive recurrent secondary glioblastoma. The main questions it aims to answer are:
Participants will
84 sGBM or IDH mutant glioblastoma patients with the ZM fusion gene will be randomly divided into group A (receive vebreltinib) or group B ( receive investigator choose), and the randomize ratio will be 1:1, patients in group A will receive PLB1001 300mg Bid, 28days/cycle. Patients in group B will receive temozolomide (100-150mg/m2/d, 7 days 1 to7 and days 15 to 22 of each 28-day cycle ) or cisplatin+etoposide(cisplatin:80-100mg/m2/3 days, 28days/cycle; etoposide:100mg/m2/d, 3days, 28 days/cycle).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLB1001 | Experimental | Subjects will receive 300mg of PLB1001 twice daily in cycles of 4 weeks duration until death or adverse event(AE) leading to discontinuation |
|
| Temozolomide or Cisplatin combined with etoposide | Active Comparator | Investigators can choose one of two treatments
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLB1001 | Drug | PLB1001 is a capsule in the form of 300mg,twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | Overall survival is defined as the time(in months)from random to the date of death. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate Evaluated by Investigator(ORR) | Objective response rate will be determined according to response assessment in neuro-oncology(RANO). | 5 years |
| Progression Free Survival evaluated by Investigator(PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenbin Li | Beijing Tiantan Hospital | Principal Investigator |
| Xiaoguang Qiu | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital,Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
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| Temozolomide | Drug | 100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle |
|
| Cisplatin combined with Etoposide | Drug | Cisplatin:80-100mg/m2/3 days,28 days/cycle Etoposide:100mg/m2/d,3 days,28 days/cycle |
|
Progression Free Survival is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD or death due to any cause.
| 5 years |
| Quality of Life Assessment EORTC-QLQ-C30 | The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures. These include the Physical Functioning Scale and four more functional scales (role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status / QoL scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. | 5 years |
| Karnofsky Performance Status score | improved is defined as KPS increases >10 after treatment; worsen is defined as KPS decreases >10; stable is defined as KPS changes ≤10. | 5 years |
| Quality of Life Assessment EORTC-QLQ-BN20 | The EORTC-QLQ-BN20 covers future uncertainty, visual disorder, motor dysfunction, communication deficit, headache, seizures, drowsiness, hair loss, itching, difficulty with bladder control, and weakness of both legs. Patients respond by self-report, with most items rated on a 4-point scale, from 1 "not at all" to 4 "very much", except for the two global health status/quality of life items, which are measured on a 7-point Likert scale ("very poor" through "excellent"). The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. | 5 years |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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