GlioblastomaPhase 2NCT04552977
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
A Phase 2 study testing fluzoparil and temozolomide in people with Glioblastoma, run by Shandong Cancer Hospital and Institute.
Trial summary
This is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the efficacy and safety of fluzoparil combined with temozolomide in patients with recurrent glioblastoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- fluzoparil and temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Aug 2022
- 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
- Voluntary participation and written informed consent;
- The age was 18-70 years old, with no gender limit;
- Supratentorial space occupying lesions were diagnosed as glioblastoma by pathology;
- Patients received standard radiotherapy and temozolomide concurrent chemotherapy after surgery, and the interval between the last radiotherapy and the last radiotherapy was ≥ 4 weeks (pseudo progression should be excluded);
- MRI confirmed that the tumor had definite recurrence. The diameter of the enhancement focus was more than 1 cm and more than 2 layers (layer spacing was 5 mm), or the recurrence was confirmed by pathology after re biopsy or operation;
- The recurrence site or other reasons can not be resected;
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- The methylation status of MGMT promoter had been detected or was willing to be detected before enrollment;
- According to recist1.1, there was at least one measurable lesion;
- KPS score ≥ 60 points;
- The tablets can be swallowed normally;
- The expected survival time was more than 3 months;
- Sufficient organs and bone marrow function. The definition is as follows.
- Neutrophil count (ANC) ≥ 1500 / mm3 (1.5 ×109 / L);
- Platelet count (PLT) ≥ 100000 / mm3 (100 × 109 / L);
- Hemoglobin (HB) ≥ 9 g / dl (90 g / L);
- Serum albumin ≥ 2.8 g / dl;
- Serum creatinine ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥ 60 ml / min;
- Total bilirubin (TB) ≤ 1.5 × ULN, or total bilirubin (TB) > 1.5 × ULN, but direct bilirubin (DBIL) ≤ 1 × ULN; patients with liver metastasis should be ≤ 2 × ULN;
- The level of AST / SGOT or ALT / SGPT should be ≤ 2.5 × ULN and ≤ 5 × ULN in patients with liver metastasis;
- Left ventricular ejection fraction (LVEF) ≥ 50%, QTc < 450 ms in male and < 470ms in female;
- The international normalized ratio (INR) of prothrombin time was ≤1.5 and activated partial thromboplastin time (APTT) were ≤1.5 times the upper limit of normal value in patients who had not received anticoagulant therapy. Patients receiving full dose or parenteral anticoagulant therapy can enter the clinical trial as long as the dosage of anticoagulant drugs is stable for at least 2 weeks before entering the clinical study, and the results of coagulation test are within the limits of local treatment;
- Women of childbearing age should have negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug; for men, it should be surgical sterilization or agree to use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug;
- Good compliance, can cooperate with the study and follow-up according to the requirements of the program.
Who cannot join
- Patients had been treated with PARP inhibitors in the past;
- Previous allergic history of temozolomide or fluzoparide, previous allergy to dacarbazine, and allergic reaction to temozolomide or fluzoparide;
- Patients had inherited galactose intolerance, lactase deficiency and glucose galactose malabsorption;
- The following treatments or drugs were received before the first study treatment:
- Major surgery (biopsy is allowed due to diagnosis) or severe trauma within 4 weeks before the first use of the study drug;
- Received strong CYP3A4 inducer or inhibitor within 2 weeks after the first use of the study drug;
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- Previously vaccinated with anti-tumor vaccine; vaccinated with live attenuated vaccine within 28 days before the first study drug treatment or within 60 days after the end of study drug treatment;
- Currently participating in other clinical studies, unless it is an observational (non intervention) clinical study or an intervention in the follow-up of a new clinical study; or has participated in any other drug clinical study within 4 weeks before the first administration, or no more than 5 half-life from the last study medication;
- Except basal cell carcinoma or squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of cervix, intraductal carcinoma in situ of breast and papillary thyroid carcinoma which can be treated locally and have been cured in the past 5 years or at the same time;
- Advanced patients with symptoms, spread to the viscera, and at risk of life-threatening complications in a short period of time (including patients with uncontrollable large amount of exudate [chest, pericardium, abdominal cavity];
- Fever of unknown origin > 38.5℃ occurred during the screening period / before the first administration (according to the researcher's judgment, fever caused by tumor can be included in the group);
- Severe infection (CTCAE > Level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. the baseline chest imaging examination revealed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics)；
- Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; hypertension with poor drug control (systolic blood pressure continuously increased ≥ 150mmhg or diastolic blood pressure ≥ 100mmhg);
- History of gastrointestinal bleeding or tendency of gastrointestinal bleeding in the past 6 months, such as esophageal varices, local active ulcer lesions, fecal occult blood≥(+) (gastroscopy is required when fecal occult blood is (+));
- Unable to swallow the study drug, chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis), intestinal obstruction and other factors affecting drug administration and absorption;
- Urine protein ≥ + + + or 24-hour urine protein > 1.0g;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or congenital immunodeficiency was known;
- Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with active pulmonary tuberculosis infection within one year before enrollment, or patients with active pulmonary tuberculosis infection history one year ago but without regular treatment;
- Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); untreated active hepatitis B (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] positive test results, HBV-DNA ≥ 500 Hepatitis C was defined as hepatitis C antibody [HCV AB] positive, HCV-RNA higher than the detection limit of analysis method and abnormal liver function), or combined with hepatitis B and hepatitis C co infection;
- Patients had a clear history of neurological or mental disorders, including epilepsy and dementia, and was known to have a history of psychotropic substance abuse, alcoholism or drug abuse;
- Patients who were considered unsuitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
This is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the efficacy and safety of fluzoparil combined with temozolomide in patients with recurrent glioblastoma.
- Conditions
- Glioblastoma
- Being tested
- fluzoparil, temozolomide
- Keywords
- glioblastoma, fluzoparil
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluzoparilDrug
a PARP1 inhibitor
temozolomideDrug
an alkylating chemotherapeutic agent
| Study group | Role | What they receive |
|---|---|---|
| fluzoparil+temozolomide | Experimental | Participants receive fluzoparil and temozolomide Receives: Drug: fluzoparil; Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-months PFS rate in all participants by RECIST 1.1
6-months progression-free survival rate in all participants by RECIST 1.1
Measured: Up to approximately 24 months
Secondary outcomes (7)
ORR in all paients by RECIST Version 1.1
ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.
Measured: Up to approximately 24 months
Disease control rate in all patients by RECIST Version 1.1
Disease control rate is defined as the proportion of patients whose best curative effect reaches complete remission, partial remission or disease control. Maintain for at least 4 weeks by RECIST Version 1.1
Measured: Up to approximately 24 months
Overall survival (OS) in all participants
OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.
Measured: Up to approximately 24 months
mPFS in all participants
mPFS was defined as as the median time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first.
Measured: Up to approximately 24 months
mOS in all participants
mOS was defined as the time from the first day of study treatment to death due to any cause.
Measured: Up to approximately 24 months
Number of participants experiencing an adverse event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
Measured: From first dose to last dose of treatment plus 2 months of follow-up, up to 24 months
Number of participants experiencing a serious adverse event (SAE)
Any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE.
Measured: From first dose to last dose of treatment plus 2 months of follow-up, 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 posted17 Sep 2020
- Study startSep 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- Jinming Yu, Ph.D, M.D, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552977
- Sponsor's protocol ID
- GBM-IIT-SHR3162-TMZ
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT04552977
- Acronym / sponsor ID
- GBM-IIT-SHR3162-TMZ
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, fluzoparil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 17 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.
This is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the efficacy and safety of fluzoparil combined with temozolomide in patients with recurrent glioblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluzoparil+temozolomide | Experimental | Drug: fluzoparil, Drug: temozolomideParticipants receive fluzoparil and temozolomide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Voluntary participation and written informed consent;
- The age was 18-70 years old, with no gender limit;
- Supratentorial space occupying lesions were diagnosed as glioblastoma by pathology;
- Patients received standard radiotherapy and temozolomide concurrent chemotherapy after surgery, and the interval between the last radiotherapy and the last radiotherapy was ≥ 4 weeks (pseudo progression should be excluded);
- MRI confirmed that the tumor had definite recurrence. The diameter of the enhancement focus was more than 1 cm and more than 2 layers (layer spacing was 5 mm), or the recurrence was confirmed by pathology after re biopsy or operation;
Key exclusion criteria (21 listed)
- Patients had been treated with PARP inhibitors in the past;
- Previous allergic history of temozolomide or fluzoparide, previous allergy to dacarbazine, and allergic reaction to temozolomide or fluzoparide;
- Patients had inherited galactose intolerance, lactase deficiency and glucose galactose malabsorption;
- The following treatments or drugs were received before the first study treatment:
- Currently participating in other clinical studies, unless it is an observational (non intervention) clinical study or an intervention in the follow-up of a new clinical study; or has participated in any other drug clinical study within 4 weeks before the first administration, or no more than 5 half-life from the last study medication;
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 |
|---|---|---|
| fluzoparila PARP1 inhibitor | Drug | fluzoparil+temozolomide |
| temozolomidean alkylating chemotherapeutic agent | Drug | fluzoparil+temozolomide |
Primary outcome
6-months PFS rate in all participants by RECIST 1.1
Time frame: Up to approximately 24 months
6-months progression-free survival rate in all participants by RECIST 1.1
7 secondary outcomes
ORR in all paients by RECIST Version 1.1
Time frame: Up to approximately 24 months
Disease control rate in all patients by RECIST Version 1.1
Time frame: Up to approximately 24 months
Overall survival (OS) in all participants
Time frame: Up to approximately 24 months
mPFS in all participants
Time frame: Up to approximately 24 months
mOS in all participants
Time frame: Up to approximately 24 months
Number of participants experiencing an adverse event (AE)
Time frame: From first dose to last dose of treatment plus 2 months of follow-up, up to 24 months
Number of participants experiencing a serious adverse event (SAE)
Time frame: From first dose to last dose of treatment plus 2 months of follow-up, 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 17 Sep 2020.
- 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.
Jinming Yu, Ph.D, M.D principal investigator
Shandong Cancer Hospital and Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fluzoparil and temozolomide in people with Glioblastoma, run by Shandong Cancer Hospital and Institute.
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 21 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 17 Sep 2020. 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 Jinming Yu, Ph.D, M.D (13806406293, sdyujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-months PFS rate in all participants by RECIST 1.1 (time frame: Up to approximately 24 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 17 Sep 2020.