Recurrent Atypical/malignant MeningiomaNCT04501705
Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
A study testing Apatinib Mesylate in people with Recurrent Atypical/malignant Meningioma, run by Beijing Sanbo Brain Hospital at 1 site in China.
Trial summary
Apatinib mesylate may be an effective treatment for recurrent atypical/malignant meningioma. This prospective clinical study is now planned to verify the effectiveness and safety of apatinib mesylate in the treatment of relapsed atypical/malignant meningioma. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Recurrent Atypical/malignant Meningioma
- What is being tested?
- Apatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2020to 31 Aug 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years old (at the time of enrollment), regardless of gender.
- The pathological diagnosis of atypical/malignant meningioma was clear after biopsy or surgery.
- The tumor recurrence is confirmed by MRI, that is, the diameter of the lesion on the enhanced MRI image is ≥1cm, and ≥2 slices (slice interval 5mm) are visible; or after another biopsy or surgery, the pathological diagnosis is atypical/malignant meningioma.
- Previous surgery and radiotherapy (including conventional radiotherapy or stereotactic radiosurgery treatment) are required. There are no restrictions on whether to receive chemotherapy or the number of times of the above treatments
- The time interval from the last radiotherapy is ≥4 weeks.
- The time interval from the last chemotherapy is ≥4 weeks, and the patients have fully recovered from the acute toxicity of the last treatment.
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- The interval between the last biopsy or surgery is ≥2 weeks.
- KPS score ≥50 points.
- If the patient is on glucocorticoid therapy, the hormone dosage has stabilized or decreased for at least 2 weeks before the baseline MRI.
- The expected survival time is ≥12 weeks.
- The main organ functions are normal, and there is no serious blood, heart, lung, liver, kidney dysfunction and immune deficiency diseases. The laboratory inspection meets the following requirements:
- Routine blood examination, which must be met (no blood transfusion within 14 days):
- HGB≥100g/L;
- WBC≥3.0×109/L; NEUT≥1.5×109/L;
- PLT ≥100×109/L; (2) The biochemical inspection shall meet the following standards:
- BIL≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.0×ULN; c. Serum Cr≤1.5×ULN or endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula); (3) Occult blood in stool (-); (4) Urine routine is normal, or urine protein <(++), or 24-hour urine protein <1.0 g; (5) Left ventricular ejection fraction (LVEF) ≥50%. 12. The coagulation function is normal, without active bleeding and thrombosis.
- International standardized ratio INR≤1.5×ULN;
- Partial thromboplastin time APTT≤1.5×ULN;
- Prothrombin time PT≤1.5ULN. 13. Female patients of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib mesylate tablets ; Male patients of childbearing age should agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of apatinib mesylate tablets.
- 14. Patients need to provide 25-30 pieces of tumor tissue slices after the last biopsy or surgery.
- 15. The patient has normal swallowing function and can swallow the tablet intact.
- 16. The patient voluntarily joined the study and signed an informed consent form (ICF).
- 17. The patient is expected to have good compliance and be able to follow up the efficacy and adverse reactions as required by the protocol.
Who cannot join
- Past application of anti-tumor angiogenesis drugs;
- Patients diagnosed with neurofibromatosis type 2 and other tumor syndromes;
- People who are known to be allergic to any component of apatinib mesylate;
- Antiepileptic drugs that induce liver enzymes are being used, unless antiepileptic drugs that have been replaced with non-hepatic enzymes are at least 2 weeks away from enrollment;
- Patients with other malignant tumors, unless they have survived for 5 years and the investigator believes that the risk of recurrence is low or patients with carcinoma in situ;
- Patients with hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg);
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- Patients with coronary heart disease ≥2 grade, arrhythmia (including QTc prolongation in men>450 ms, women>470 ms) and cardiac insufficiency;
- Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;
- Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5×ULN), have bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
- There are many factors that affect the absorption of oral drugs, such as uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction;
- There is an infection that is difficult to control;
- Those who had significant blood coughing up 2 months before enrollment, or had blood volume of 2.5ml or more per day; had clinically significant bleeding symptoms or had clear bleeding tendency within 3 months before enrollment, such as Gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, stool occult blood++ and above at baseline, intratumoral or intracranial hemorrhage, or vasculitis, etc.;
- Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;
- Other situations that the researcher thinks are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sanbo Brain Hospital
Beijing, Beijing Municipality
Jun-ping Zhang, Chief Physician, 86-010-62856783
About this study
Official title: Clinical Study of Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
Apatinib mesylate may be an effective treatment for recurrent atypical/malignant meningioma. This prospective clinical study is now planned to verify the effectiveness and safety of apatinib mesylate in the treatment of relapsed atypical/malignant meningioma.
Read the detailed description
Vascular endothelial growth factor VEGF is related to the abnormal angiogenesis of meningioma and can also activate other growth factor pathways. Meningiomas are vascular tumors. Studies have shown that the expression of VEGF in atypical meningiomas is twice that of benign meningiomas, and VEGF in anaplastic meningiomas is 10 times that of benign meningiomas. Therefore, anti-angiogenesis therapy may be more effective for higher grade meningiomas. Previous clinical studies have confirmed that anti-angiogenic drugs such as bevacizumab, sunitinib and PTK 787 can slow down tumor growth and prolong progression-free survival for recurrent atypical/malignant meningioma. In summary, apatinib mesylate may be an effective treatment for recurrent atypical/malignant meningioma. This prospective clinical study is now planned to verify the effectiveness and safety of apatinib mesylate in the treatment of relapsed atypical/malignant meningioma.
- Conditions
- Recurrent Atypical/malignant Meningioma
- Being tested
- Apatinib Mesylate
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib MesylateDrug
Apatinib mesylate tablets: Orally, 500 mg, once a day, with warm water for half an hour after a meal (the time of taking the medicine every day should be the same as possible).
Continue to use 28 days as a cycle, medication until disease progression (PD), intolerable toxicity occurs or the patient withdraws informed consent. However, the longest period does not exceed 24 cycles, and the treatment after 24 cycles is determined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Not described Receives: Drug: Apatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS-6 %
6-month progression-free survival
Measured: 6-month progression-free survival
Secondary outcomes (2)
ORR
Objective Response Rate
Measured: up to 5 years
OS
Overall survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start18 Aug 2020
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Atypical/malignant MeningiomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junping Zhang, Beijing Sanbo Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501705
- Sponsor's protocol ID
- OBU-BJ-CM-Ⅱ-008
- Status last verified
- Oct 2024
- First submitted
- 4 Aug 2020
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Apatinib in the Treatment of Recurrent Atypical/malignant Meningioma in Adults
- ClinicalTrials.gov ID
- NCT04501705
- Acronym / sponsor ID
- OBU-BJ-CM-Ⅱ-008
- Conditions
- Recurrent Atypical/malignant Meningioma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Aug 2020 (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.
Apatinib mesylate may be an effective treatment for recurrent atypical/malignant meningioma. This prospective clinical study is now planned to verify the effectiveness and safety of apatinib mesylate in the treatment of relapsed atypical/malignant meningioma.
Detailed description
Vascular endothelial growth factor VEGF is related to the abnormal angiogenesis of meningioma and can also activate other growth factor pathways. Meningiomas are vascular tumors. Studies have shown that the expression of VEGF in atypical meningiomas is twice that of benign meningiomas, and VEGF in anaplastic meningiomas is 10 times that of benign meningiomas. Therefore, anti-angiogenesis therapy may be more effective for higher grade meningiomas. Previous clinical studies have confirmed that anti-angiogenic drugs such as bevacizumab, sunitinib and PTK 787 can slow down tumor growth and prolong progression-free survival for recurrent atypical/malignant meningioma. In summary, apatinib mesylate may be an effective treatment for recurrent atypical/malignant meningioma. This prospective clinical study is now planned to verify the effectiveness and safety of apatinib mesylate in the treatment of relapsed atypical/malignant meningioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: Apatinib Mesylate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥18 years old (at the time of enrollment), regardless of gender.
- The pathological diagnosis of atypical/malignant meningioma was clear after biopsy or surgery.
- The tumor recurrence is confirmed by MRI, that is, the diameter of the lesion on the enhanced MRI image is ≥1cm, and ≥2 slices (slice interval 5mm) are visible; or after another biopsy or surgery, the pathological diagnosis is atypical/malignant meningioma.
- Previous surgery and radiotherapy (including conventional radiotherapy or stereotactic radiosurgery treatment) are required. There are no restrictions on whether to receive chemotherapy or the number of times of the above treatments
- The time interval from the last radiotherapy is ≥4 weeks.
Key exclusion criteria (15 listed)
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 |
|---|---|---|
| Apatinib MesylateApatinib mesylate tablets: Orally, 500 mg, once a day, with warm water for half an hour after a meal (the time of taking the medicine every day should be the same as possible). Continue to use 28 days as a cycle, medication until disease progression (PD), intolerable toxicity occurs or the patient withdraws informed consent. However, the longest period does not exceed 24 cycles, and the treatment after 24 cycles is determined by the investigator. | Drug | test group |
Primary outcome
PFS-6 %
Time frame: 6-month progression-free survival
6-month progression-free survival
2 secondary outcomes
ORR
Time frame: up to 5 years
OS
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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 study testing Apatinib Mesylate in people with Recurrent Atypical/malignant Meningioma, run by Beijing Sanbo Brain Hospital 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 23 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 15 Oct 2024. 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.
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 Jun-ping Zhang, Chief Physician (86-010-62856783, doczhjp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS-6 % (time frame: 6-month progression-free survival). 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 15 Oct 2024.