Recurrent GlioblastomaPhase 2NCT04715620
Niraparib Combined With Radiotherapy in rGBM
A Phase 2 study testing Niraparib in people with Recurrent Glioblastoma, run by Tianjin Huanhu Hospital at 1 site in China.
Trial summary
Thirty patients were enrolled in this study, mainly patients with first recurrence of glioblastoma, and the requirement is that they can receive secondary radiotherapy. Regardless of whether the patient has received a second operation or the MGMT promoter is methylated, they can be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- Niraparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2021to Jan 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form before conducting any research related procedures;
- Male or female aged between 18 and 70;
- Histologically confirmed WHO classification of recurrent glioblastoma grade IV;
- The expected survival time is more than 6 months
- Able to receive radiotherapy again
- KPS≥60
Show all 11Show fewer
- Can swallow and maintain oral medication
- In the past month, no more than 3 grand epileptic seizures per week
- Good organ function, including: Bone marrow function: neutrophil count ≥1500/µL; platelets ≥100,000/µL; hemoglobin ≥10g/dL; Liver function: total bilirubin ≤1.5 times the upper limit of normal or direct bilirubin ≤1.0 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal; Renal function: serum creatinine ≤1.5 times the upper limit of normal value, or creatinine clearance ≥60mL/min (calculated according to Cockcroft-Gault formula);
- Ability to follow the plan;
- Any previous toxicity of chemotherapy has returned to ≤ CTCAE level 1 or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤ CTCAE level 2.
Who cannot join
- Those who are known to be allergic to niraparib or the active or inactive ingredients of drugs with similar chemical structure to niraparib;
- Those who have previously received PARP inhibitor therapy;
- Have received major surgery within 3 weeks before the start of the study, or any surgical effects that have not recovered after surgery or received chemotherapy;
- Received palliative radiotherapy with> 20% bone marrow 1 week before enrollment;
- The patient has previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- Suffer from serious or uncontrolled diseases, including but not limited to:
Show all 9Show fewer
- Uncontrollable nausea and vomiting, inability to swallow study drugs, any gastrointestinal diseases that may interfere with drug absorption and metabolism; active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; uncontrolled ventricular Arrhythmia, myocardial infarction in the last 3 months; uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders that affect the patient's informed consent; immunodeficiency (except splenectomy) Or other researchers believe that it may expose patients to high-risk toxic diseases; hypertension that cannot be controlled by drugs; and manifestations of intracranial hypertension, intracranial hemorrhage, and intracranial infarction caused by any reason;
- Patients with distant metastasis;
- Any past or current disease, treatment, or laboratory abnormality that may interfere with the results of the study, affect the patient's full participation in the study, or the investigator believes that the patient is not suitable for participating in the study; the patient must not be allowed within four weeks before the start of the study drug treatment Receive platelet or red blood cell transfusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Huanhu Hosptal
Tianjin, Tianjin Municipality, 300350
Zheng Wang, +86 22 59065906, afjsh@163.com
About this study
Official title: Efficacy and Safety of Niraparib Combined With Radiotherapy in Patients With Recurrent Glioblastoma
Thirty patients were enrolled in this study, mainly patients with first recurrence of glioblastoma, and the requirement is that they can receive secondary radiotherapy. Regardless of whether the patient has received a second operation or the MGMT promoter is methylated, they can be included in this study. After enrollment, patients were given niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/µL), combined with radiotherapy (total dose 55Gy), follow-up Time 1 year. Until the patient has disease progression or intolerance or voluntarily withdraw from the study.
- Conditions
- Recurrent Glioblastoma
- Being tested
- Niraparib
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/µL)
| Study group | Role | What they receive |
|---|---|---|
| niraparib | Experimental | Not described Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS-6
6-month progression-free survival rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Wei, Tianjin Huanhu Hospital
- Investigators
- Wei Jiang, Principal investigator, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715620
- Sponsor's protocol ID
- TJHH-2306
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Niraparib Combined With Radiotherapy in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT04715620
- Acronym / sponsor ID
- TJHH-2306
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 20 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.
Thirty patients were enrolled in this study, mainly patients with first recurrence of glioblastoma, and the requirement is that they can receive secondary radiotherapy. Regardless of whether the patient has received a second operation or the MGMT promoter is methylated, they can be included in this study. After enrollment, patients were given niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/µL), combined with radiotherapy (total dose 55Gy), follow-up Time 1 year. Until the patient has disease progression or intolerance or voluntarily withdraw from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| niraparib | Experimental | Drug: Niraparib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sign a written informed consent form before conducting any research related procedures;
- Male or female aged between 18 and 70;
- Histologically confirmed WHO classification of recurrent glioblastoma grade IV;
- The expected survival time is more than 6 months
- Able to receive radiotherapy again
Key exclusion criteria (9 listed)
- Those who are known to be allergic to niraparib or the active or inactive ingredients of drugs with similar chemical structure to niraparib;
- Those who have previously received PARP inhibitor therapy;
- Have received major surgery within 3 weeks before the start of the study, or any surgical effects that have not recovered after surgery or received chemotherapy;
- Received palliative radiotherapy with> 20% bone marrow 1 week before enrollment;
- The patient has previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
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 |
|---|---|---|
| NiraparibNiraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/µL) | Drug | niraparib |
Primary outcome
PFS-6
Time frame: 6 months
6-month progression-free survival rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Related trials for Recurrent Glioblastoma
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
Not yet recruiting
Safety and Efficacy of Autologous Natural Killer Cell Therapy (CHANK-101) in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
RecruitingPhase 2/3
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Glioblastoma
RecruitingPhase 1
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Glioblastoma Multiforme, Recurrent Glioblastoma
Not yet recruitingPhase 1
IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Newly Diagnosed and Recurrent Pediatric High-grade Glioma (pHGG) and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (ndDIPG)
High-grade Glioma, Diffuse Intrinsic Pontine Glioma
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.
Wei Jiang principal investigator
Tianjin Huanhu Hospital
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 Niraparib in people with Recurrent Glioblastoma, run by Tianjin Huanhu 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 11 inclusion and 9 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 20 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?
Contact Wei Jiang (+86 22 59065906, wjianghh@163.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 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 20 Jan 2021.