GlioblastomaPhase 2NCT04547855
Anlotinib Combined With Dose-dense Temozolomide for the First Recurrent or Progressive Glioblastoma After STUPP Regimen
A Phase 2 study testing anlotinib combined with dose-dense temozolomide in people with Glioblastoma, run by Yonggao Mou at 1 site in China.
Trial summary
Currently,6 cycles of Temozolomide adjuvant chemotherapy after concurrent radiotherapy and Temozolomide chemotherapy(STUPP regimen)for newly diagnosed postoperative GBM can increase the 2-year and 5-year overall survival rates of patients to 26.5% and 9.8%, respectively. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- anlotinib combined with dose-dense temozolomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2020to 11 Mar 2023
- Phase
- Phase 2
- 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
- The primary tumor must be pathologically confirmed as supratentorial glioblastoma;
- The primary tumor progressed or relapsed for the first time after surgery (including biopsy, partial resection, total resection), standard radiotherapy and temozolomide concurrent chemotherapy and temozolomide adjuvant chemotherapy (STUPP regimen), including multiple intracranial recurrence and new lesions.;
- Age ≥ 18 years old,≤75 years old;
- KPS ≥ 60;
- the expected survival time is more than 12 weeks;
- within 28 days before entering the group, patients need to undergo craniocerebral enhanced MRI, and the lesions on MRI must be measurable;
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- for patients undergoing the second surgery after the first recurrence, baseline MRI should be obtained at least 4 weeks after operation;
- if the patient is undergoing hormone therapy, the hormone dose must be stable or reduced at least 5 days before baseline MRI;
- For patients undergoing re-radiation therapy, the baseline MRI should be obtained at least 8 weeks or 4 weeks after the end of the radiotherapy (the recurrence lesion is not in the radiation field);
- For patients who are treated with gamma knife or other hyperdivision methods for the first time, Recurrence or progression must be confirmed by pathology (except for patients with new lesions);
- Peripheral blood picture, liver and kidney function, etc. are within the following allowable range (detected within 7 days before the start of treatment): neutrophils (ANC) ≥ 1.5×109/L; hemoglobin (HGB) ≥100g/L; platelets (PLT) ≥100×109/L; liver transaminase (AST/ALT) ≤2.5 times the upper limit of the normal range; total bilirubin (TBIL) <1.5 times the upper limit of the normal range; Creatinine (CREAT) <1.2 times the upper limit of the normal range; International normalized ratio (INR) <1.5; Activated partial thromboplastin time (APTT) <1.5 times the upper limit of the normal range (except for patients receiving anticoagulation therapy); Urinary protein (PRO)/creatinine (CRE) ratio ≤1.0;
- The patient must have fully recovered from the toxicity of previous chemotherapy or targeted therapy, and at least 30 days from the last treatment; 13.Before starting treatment, the patient must Complete recovery from surgery, postoperative infection or other comorbidities;
- 14.Patients of childbearing age (including female and male patients' female partners) must take effective birth control measures; 15.Sign informed consent.
Who cannot join
- 1.Patients who have participated in other clinical trials in the past and have not terminated the trial; 2.Patients who have used Anlotinib in the past; 3. Baseline MRI suggests the recent risk of cerebral hemorrhage or brain herniation; 4. Pregnant or breast-feeding women; 5.Those who are difficult to control acute infections; 6. People who take drugs, drug abuse, long-term alcoholism and AIDS; 7.Have frequent vomiting or have conditions that affect the oral administration of drugs; 8. Hypertension that cannot be controlled by drugs The patient (>150/100mmHg); 9. Previous hypertensive encephalopathy; 10. Hemorrhage tendency or coagulopathy; 11. Thrombolytic or anticoagulant therapy (unless low molecular weight heparin or warfarin is used); 12).≥ Grade 2 cardiac insufficiency (NYHA criteria) or congestive heart failure; 13. Past history of myocardial infarction or unstable angina, stroke and transient ischemic attack within 6 months; 14. Serious vascular disease; 15.Peripheral artery embolism occurred recently; 16. Abdominal fistula, gastrointestinal perforation and abdominal abscess occurred in the past; 17.Intracranial abscess occurred within 6 months; 18. Major surgery, open biopsy or Have suffered major trauma; 19. Those who are expected to undergo major surgery; 20).Those who have severe incurable wounds, ulcers or fractures; 21).Those with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 22.patients who are allergic to known ingredients of Anlotinib; 23.There is a serious skin disease; 24. Other concomitant diseases that seriously endanger the safety of patients or affect the completion of the study according to the judgment of the investigator .
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
QUN-YING YANG, MD, 13802971439, yangqy@sysucc.org.cn
About this study
Official title: A Phase II Study of Anlotinib Combined With Dose-dense Temozolomide for the First Recurrent or Progressive Glioblastoma After STUPP Regimen
Currently,6 cycles of Temozolomide adjuvant chemotherapy after concurrent radiotherapy and Temozolomide chemotherapy(STUPP regimen)for newly diagnosed postoperative GBM can increase the 2-year and 5-year overall survival rates of patients to 26.5% and 9.8%, respectively. However, most patients are still unable to avoid tumor recurrence and death.Anlotinib is an efficient multi-target tyrosine kinase inhibitor (TKI) that effectively block the migration and proliferation of endothelial cells and reduce tumor microvascular density by targeting VEGFRs, FGFRs, PDGFRs. It has been proved to be safe and effective in advanced lung cancer(including NSCLC,SCLC)after second-line standard chemotherapy failure,and advanced soft tissue sarcoma after anthracycline-containing chemotherapy failure.Here, we prepared to evaluate whether the combination of dose-dense Temozolomide and Anlotinib can preferably improved survival of the first recurrent or progressive GBM after STUPP regimen.
- Conditions
- Glioblastoma
- Being tested
- anlotinib combined with dose-dense temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anlotinib combined with dose-dense temozolomideDrug
Also called Anlotinib hydrochloride capsule
Temozolomide Capsule 150mg, p.o., qd, d1-7,15-21,4 weeks one cycle; Anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | anlotinib combined with dose-dense temozolomide Receives: Drug: anlotinib combined with dose-dense temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months Objective Response Rates
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using as Assessed by Investigator Using RANO Version 1.1
Measured: 6 month
6 months Progression-Free Survival Rates
6 months Progression-Free Survival Rates as Assessed by Investigator Using RANO Version 1.1
Measured: 6 months
Secondary outcomes (3)
Progress-free survival (PFS)
Progression-Free Survival (PFS) as Assessed by Investigator Using RANO Version 1.1
Measured: Approximately 6 months
overall survival
OS was defined as the time from the date of randomization to the date of death due to any cause.
Measured: Approximately 1 years
Toxic side effects
Toxic side effects as Assessed by Investigator Using RANO Version 1.1
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start11 Sep 2020
- Primary completion11 Sep 2022 (estimated)
- Study completion11 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonggao Mou
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Responsible party
- Sponsor-investigator, Yonggao Mou, Sun Yat-sen University
- Investigators
- QUN-YING YANG, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547855
- Sponsor's protocol ID
- Qun-Ying YANG
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Anlotinib Combined With Dose-dense Temozolomide for the First Recurrent or Progressive Glioblastoma After STUPP Regimen
- ClinicalTrials.gov ID
- NCT04547855
- Acronym / sponsor ID
- Qun-Ying YANG
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Yonggao MouUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 11 Sep 2022 (estimated)
- Study completion
- 11 Mar 2023 (estimated)
- First posted
- 14 Sep 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.
Currently,6 cycles of Temozolomide adjuvant chemotherapy after concurrent radiotherapy and Temozolomide chemotherapy(STUPP regimen)for newly diagnosed postoperative GBM can increase the 2-year and 5-year overall survival rates of patients to 26.5% and 9.8%, respectively. However, most patients are still unable to avoid tumor recurrence and death.Anlotinib is an efficient multi-target tyrosine kinase inhibitor (TKI) that effectively block the migration and proliferation of endothelial cells and reduce tumor microvascular density by targeting VEGFRs, FGFRs, PDGFRs. It has been proved to be safe and effective in advanced lung cancer(including NSCLC,SCLC)after second-line standard chemotherapy failure,and advanced soft tissue sarcoma after anthracycline-containing chemotherapy failure.Here, we prepared to evaluate whether the combination of dose-dense Temozolomide and Anlotinib can preferably improved survival of the first recurrent or progressive GBM after STUPP regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: anlotinib combined with dose-dense temozolomideanlotinib combined with dose-dense temozolomide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The primary tumor must be pathologically confirmed as supratentorial glioblastoma;
- The primary tumor progressed or relapsed for the first time after surgery (including biopsy, partial resection, total resection), standard radiotherapy and temozolomide concurrent chemotherapy and temozolomide adjuvant chemotherapy (STUPP regimen), including multiple intracranial recurrence and new lesions.;
- Age ≥ 18 years old,≤75 years old;
- KPS ≥ 60;
- the expected survival time is more than 12 weeks;
Key exclusion criteria (1 listed)
- 1.Patients who have participated in other clinical trials in the past and have not terminated the trial; 2.Patients who have used Anlotinib in the past; 3. Baseline MRI suggests the recent risk of cerebral hemorrhage or brain herniation; 4. Pregnant or breast-feeding women; 5.Those who are difficult to control acute infections; 6. People who take drugs, drug abuse, long-term alcoholism and AIDS; 7.Have frequent vomiting or have conditions that affect the oral administration of drugs; 8. Hypertension that cannot be controlled by drugs The patient (>150/100mmHg); 9. Previous hypertensive encephalopathy; 10. Hemorrhage tendency or coagulopathy; 11. Thrombolytic or anticoagulant therapy (unless low molecular weight heparin or warfarin is used); 12).≥ Grade 2 cardiac insufficiency (NYHA criteria) or congestive heart failure; 13. Past history of myocardial infarction or unstable angina, stroke and transient ischemic attack within 6 months; 14. Serious vascular disease; 15.Peripheral artery embolism occurred recently; 16. Abdominal fistula, gastrointestinal perforation and abdominal abscess occurred in the past; 17.Intracranial abscess occurred within 6 months; 18. Major surgery, open biopsy or Have suffered major trauma; 19. Those who are expected to undergo major surgery; 20).Those who have severe incurable wounds, ulcers or fractures; 21).Those with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 22.patients who are allergic to known ingredients of Anlotinib; 23.There is a serious skin disease; 24. Other concomitant diseases that seriously endanger the safety of patients or affect the completion of the study according to the judgment of the investigator .
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 |
|---|---|---|
| anlotinib combined with dose-dense temozolomideAlso: Anlotinib hydrochloride capsuleTemozolomide Capsule 150mg, p.o., qd, d1-7,15-21,4 weeks one cycle; Anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle. | Drug | experimental group |
Primary outcome
6 months Objective Response Rates
Time frame: 6 month
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using as Assessed by Investigator Using RANO Version 1.1
6 months Progression-Free Survival Rates
Time frame: 6 months
6 months Progression-Free Survival Rates as Assessed by Investigator Using RANO Version 1.1
3 secondary outcomes
Progress-free survival (PFS)
Time frame: Approximately 6 months
overall survival
Time frame: Approximately 1 years
Toxic side effects
Time frame: Approximately 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: Yes
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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.
QUN-YING YANG, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anlotinib combined with dose-dense temozolomide in people with Glioblastoma, run by Yonggao Mou 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 13 inclusion and 1 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 Sep 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 QUN-YING YANG, MD (13802971439, yangqy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months Objective Response Rates (time frame: 6 month). 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 Sep 2020.