MGMT-Unmethylated GlioblastomaPhase 2NCT04725214
Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma
A Phase 2 study testing Anlotinib in people with MGMT-Unmethylated Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MGMT-Unmethylated Glioblastoma
- What is being tested?
- Anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2021to Dec 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
- Aged 18-70 years,
- Histologically proven diagnosis of glioblastoma (WHO grade IV),
- Have received standard STUPP treatment plan,
- Gross resection or partial resection of the tumor (confirmed by MRI)> 50%,
- The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60,
- No previous radiotherapy, chemotherapy, immunotherapy or biotherapy 7.Adequate bone marrow function: Hemoglobin ≥ 100g/L，Platelets ≥ 80×109/L，Absolute neutrophil count (ANC) ≥ 1.5×109/L
- 8.Adequate renal function: Serum creatinine ≤ 1.25 x UNL (upper normal limit) or creatinine clearance ≥ 60 ml/min 9.Adequate hepatic function: serum bilirubin ≤ 1.5 x UNL, AST and ALT ≤ 2.5 x UNL，ALP≤5x UNL 10.For females of child-bearing potential, negative serum pregnancy test within 14 days prior to registration. Women of childbearing potential and male participants must practice adequate contraception during participation in the study and within 8 weeks after the last administration of the drug 11.Able to provide written informed consent
Who cannot join
- Recurrent or multiple malignant gliomas
- Subtentorial glioblastoma or metastatic lesions outside the skull
- Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery
- Previously received radiation therapy for the head and neck cancer
- Have received any antibody treatment before
- Contraindication of radiotherapy and chemotherapy defined as follows: Acute bacterial or fungal infection，Unstable angina and/or congestive heart failure within the last 6 months，co-morbidity with immunosuppressive therapy
- Evidence of bleeding diathesis or coagulopathy
- Prior invasive malignancy (except for non-melanomatous skin cancer or carcinoma in situ of cervix)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
qichun wei, MD, 086-0571-87783521, qichun_wei@zju.edu.cn
yongjie shui, MM, 086-0571-87783521, syjhz@163.com
About this study
Official title: Anlotinib Combined With STUPP Protocol as First-line Regimen for MGMT Nonmethylated Glioblastoma: a Multicenter, Open-label, Single-arm, Phase II Clinical Trial
The purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.
Read the detailed description
For MGMT unmethylated glioblastoma patients undergoing STUPP regimen adjuvant therapy, during adjuvant chemotherapy, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14).
- Conditions
- MGMT-Unmethylated Glioblastoma
- Being tested
- Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Also called temozolomide capsule
Anlotinib With STUPP Regimen
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | For MGMT unmethylated glioblastoma, during temozolomide adjuvant, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14) Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year OS
1-year overall survival
Measured: from enrollment to death (for any reason).assessed up to 12 months
Secondary outcomes (5)
PFS
Progression-Free Survival
Measured: from enrollment to progression or death (for any reason),assessed up to 24months
OS
Overall Survival
Measured: from enrollment to death (for any reason).assessed up to 24 months
adverse event
Adverse events are described in terms of CTC AE 5.0
Measured: from enrollment to death (for any reason).assessed up to 24 months
Health-related quality of life
Health-related quality of life are measured by the EORTC-QL30/BN20
Measured: from enrollment to death (for any reason).assessed up to 24 months
Neurocognitive function
Neurocognitive function are measured by John-Hopkins adapted cognitive exam (ACE)
Measured: from enrollment to death (for any reason).assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start15 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MGMT-Unmethylated GlioblastomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Model description
- Adjuvant therapy with Anlotinib and Temozolomide for MGMT nonmethylated glioblastoma after concurrent chemo-radiotherapy
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qichun Wei, MD, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725214
- Sponsor's protocol ID
- 2020-780
- Status last verified
- Jan 2021
- First submitted
- 17 Jan 2021
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Combined With STUPP Protocol as First-line Regimen for MGMT Nonmethylated Glioblastoma: a Multicenter, Open-label, Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04725214
- Acronym / sponsor ID
- 2020-780
- Conditions
- MGMT-Unmethylated Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Jan 2021 (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 purpose of this study is to test the efficacy and safety of Anlotinib in combination with STUPP regimen for MGMT promoter nonmethylated glioblastoma.
Detailed description
For MGMT unmethylated glioblastoma patients undergoing STUPP regimen adjuvant therapy, during adjuvant chemotherapy, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adjuvant therapy with Anlotinib and Temozolomide for MGMT nonmethylated glioblastoma after concurrent chemo-radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: AnlotinibFor MGMT unmethylated glioblastoma, during temozolomide adjuvant, concurrent with anti-angiogenesis targeted therapy(Anlotinib capsule,d1-14) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-70 years,
- Histologically proven diagnosis of glioblastoma (WHO grade IV),
- Have received standard STUPP treatment plan,
- Gross resection or partial resection of the tumor (confirmed by MRI)> 50%,
- The pathological tissue specimens are detected as MGMT unmethylated,6.Karnofsky performance status ≥ 60,
Key exclusion criteria (8 listed)
- Recurrent or multiple malignant gliomas
- Subtentorial glioblastoma or metastatic lesions outside the skull
- Have received radiotherapy, chemotherapy or other anti-tumor drugs for the disease before surgery
- Previously received radiation therapy for the head and neck cancer
- Have received any antibody treatment before
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 |
|---|---|---|
| AnlotinibAlso: temozolomide capsuleAnlotinib With STUPP Regimen | Drug | Experimental |
Primary outcome
1-year OS
Time frame: from enrollment to death (for any reason).assessed up to 12 months
1-year overall survival
5 secondary outcomes
PFS
Time frame: from enrollment to progression or death (for any reason),assessed up to 24months
OS
Time frame: from enrollment to death (for any reason).assessed up to 24 months
adverse event
Time frame: from enrollment to death (for any reason).assessed up to 24 months
Health-related quality of life
Time frame: from enrollment to death (for any reason).assessed up to 24 months
Neurocognitive function
Time frame: from enrollment to death (for any reason).assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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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.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Qichun Wei, MD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 in people with MGMT-Unmethylated Glioblastoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 8 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 26 Jan 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year OS (time frame: from enrollment to death (for any reason).assessed up to 12 months). 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 26 Jan 2021.