GliomaPhase 2NCT03390062
A Study of Apatinib in Recurrent or Recurrent High-grade Glioma
A Phase 2 study testing Apatinib in people with Glioma, run by West China Hospital.
Trial summary
The purpose of this study is to determine the effectiveness and safety of Apatinib for patients with Recurrent or Recurrent High-grade Glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2018to 1 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 18 years old, male or female;
- 2. The histologically confirmed first-line after the surgical resection of the WHOIII / IV glioma or previous surgery and / or radiotherapy and chemotherapy after the recurrence of WHOIII / IV glioma;
- 3. ECOG score: 0-2 points;
- 4. The main organs function properly, that is, meet the following criteria:(1) blood test:a. HGB≥90 g / L;b. ANC ≧ 1.5 × 109 / L;c. PLT ≥80 × 109 / L;(2) biochemical examination:a. ALB≥30g / L;b. ALT and AST <2*ULN;c. TBIL≤1.5*ULN; d. Plasma Cr≤1.5 *ULN;
- 5. No history of mental illness in patients;
- 6. Thyroid function is normal;
- 7. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Who cannot join
- 1. Pregnant or lactating women;
- 2. Hypertensive patients who are not well controlled by antihypertensive medication (systolic blood pressure> 150 mmHg and diastolic blood pressure> 100 mmHg); those with grade I or greater myocardial ischemia or myocardial infarction, arrhythmia (including QT Period ≥ 440 ms) and grade I cardiac insufficiency, grading reference NCI-CTC AE 3.0;
- 3. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption;
- 4. Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding;
- 5. Have mental illness, or history of substance abuse;
- 6. Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; allowing the use of small doses of prophylaxis for prophylaxis, provided that the prothrombin time has an International Normalized Ratio (INR) ≤1.5 Farin (1 mg orally, once daily), low dose heparin (6,000 to 12,000 U daily for adults), or low dose aspirin (80 to 100 mg daily);
- 7. Researchers think it is not suitable for inclusion. All patients underwent CT or MRI of the head one week prior to the start of the protocol, with intracranial hemorrhage.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An One Arm, Open and Prospective Studyof Apatinib for the Treatment of Recurrent or Recurrent High-grade Glioma
The purpose of this study is to determine the effectiveness and safety of Apatinib for patients with Recurrent or Recurrent High-grade Glioma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called Aitan
Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue.
| Study group | Role | What they receive |
|---|---|---|
| apatinib | Experimental | apatinib 500 mg orally daily until the untolerabale toxicities、desease progress or death Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Measured: 24 month
Progress-free Survival(PFS)
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Measured: 24month
Secondary outcomes (2)
Objective Response Rate(ORR)
Proportion of patients with reduction in tumor burden of a predefined amount
Measured: 6month
EORTC QLQ-C30
The EORTC Quality of Life questionnaires are developed to assess the quality of life of cancer patients.
Measured: 24month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start4 Jan 2018 (estimated)
- Primary completion20 Dec 2019 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Li ping, West China Hospital
- Investigators
- qing Mao, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390062
- Sponsor's protocol ID
- Ahead-G-201702
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An One Arm, Open and Prospective Studyof Apatinib for the Treatment of Recurrent or Recurrent High-grade Glioma
- ClinicalTrials.gov ID
- NCT03390062
- Acronym / sponsor ID
- Ahead-G-201702
- Conditions
- Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 4 Jan 2018 (estimated)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 4 Jan 2018 (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 determine the effectiveness and safety of Apatinib for patients with Recurrent or Recurrent High-grade Glioma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apatinib | Experimental | Drug: Apatinibapatinib 500 mg orally daily until the untolerabale toxicities、desease progress or death |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age ≥ 18 years old, male or female;
- 2. The histologically confirmed first-line after the surgical resection of the WHOIII / IV glioma or previous surgery and / or radiotherapy and chemotherapy after the recurrence of WHOIII / IV glioma;
- 3. ECOG score: 0-2 points;
- 4. The main organs function properly, that is, meet the following criteria:(1) blood test:a. HGB≥90 g / L;b. ANC ≧ 1.5 × 109 / L;c. PLT ≥80 × 109 / L;(2) biochemical examination:a. ALB≥30g / L;b. ALT and AST <2*ULN;c. TBIL≤1.5*ULN; d. Plasma Cr≤1.5 *ULN;
- 5. No history of mental illness in patients;
Key exclusion criteria (7 listed)
- 1. Pregnant or lactating women;
- 2. Hypertensive patients who are not well controlled by antihypertensive medication (systolic blood pressure> 150 mmHg and diastolic blood pressure> 100 mmHg); those with grade I or greater myocardial ischemia or myocardial infarction, arrhythmia (including QT Period ≥ 440 ms) and grade I cardiac insufficiency, grading reference NCI-CTC AE 3.0;
- 3. Unable to swallow, chronic diarrhea and intestinal obstruction, significantly affect the medication and absorption;
- 4. Have a clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++ above), within 6 months history of gastrointestinal bleeding;
- 5. Have mental illness, or history of substance abuse;
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 |
|---|---|---|
| ApatinibAlso: AitanApatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. | Drug | apatinib |
Primary outcome
Overall Survival(OS)
Time frame: 24 month
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Progress-free Survival(PFS)
Time frame: 24month
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
2 secondary outcomes
Objective Response Rate(ORR)
Time frame: 6month
EORTC QLQ-C30
Time frame: 24month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Glioma
Active, not recruitingPhase 1/2
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EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
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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.
qing Mao, M.D. principal investigator
West China Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib in people with Glioma, run by West China Hospital.
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 7 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 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 ping Li, M.D. (08618980602780, lipinglunwen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: 24 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 4 Jan 2018.