A Phase II Clinical Study to Evaluate the Efficacy and Safety of Flazoparib Combined With Temozolomide After the Completion of Standard Concurrent Chemoradiotherapy (CCRT) in Newly Diagnosed Glioblastoma

NCT07047066 | Not Yet Recruiting Phase 2

• 1 other identifier: GBM-Ⅱ-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase II clinical study is planned to evaluate the efficacy and safety of fluzoparib combined with temozolomide in newly diagnosed glioblastoma patients after completing standard concurrent chemoradiotherapy (CCRT), explore the effectiveness and safety of this regimen, and find a better treatment option for glioblastoma patients

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• OS

  Defined as the time from the date of randomization to death from any cause.

  Patients were assessed up to 36 months from enrollment to first death (whichever occurred first)

Secondary Outcomes (2)

• PFS

  From enrollment to the first appearance of disease progression or date death from any cause,whichever came first,assessed up to 36 mounths

• ORR

  From enrollment to initial efficacy evaluation ,assessed up to 6 months

Study Arms (1)

Fluzoparib combined with Temozolomide

EXPERIMENTAL

Drug: Fluzoparib with Temozolomide

Interventions

Fluzoparib with Temozolomide DRUG

Fluzoparib: 100mg, po.bid. Q4W, d1-28, for a total of 6 cycles Temozolomide (TMZ): 150-200 mg/m2, po. Q4W, d1-5, for a total of 6 cycles If unacceptable toxicity occurs and a dose reduction is required, it is recommended to first reduce the dose from 100 mg (2 tablets) to 50 mg (1 tablet) twice a day. If further dose reduction is required, it is recommended to reduce the dose from 50 mg (1 tablet) twice a day to 50 mg (1 tablet) once a day. If it is still intolerable, the patient should withdraw from the clinical study. The TMZ dose is adjusted by the investigator according to standard chemotherapy requirements. Adjuvant TMZ treatment of less than 6 cycles is allowed depending on the subject's condition (e.g. confirmed disease progression, intolerable toxicity, etc.). Tumor assessment is performed during two cycles of TMZ (q8w±7 days) during the study or when clinically indicated

Fluzoparib combined with Temozolomide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form (ICF);
• \. Age ≥18 years old, \<70 years old;
• \. Based on postoperative MRI, the total resection range is ≥80% compared with preoperative MRI (resection for the purpose of biopsy is not eligible);
• \. Patients newly diagnosed with primary glioblastoma by imaging or pathology, completed concurrent chemoradiotherapy (CCRT), and planned to receive adjuvant TMZ treatment;
• \. Appropriate hematological treatment and end-organ function within 14 days before randomization, defined by the following laboratory results:
• Absolute neutrophil count (ANC) ≥1.5×109/L;
• Platelet count ≥100×109/L;
• Hemoglobin ≥90 g/L;
• Total bilirubin ≤1.5 ×ULN;
• AST and ALT ≤3 × ULN;
• Alkaline phosphatase ≤2.5 × ULN;
• Serum albumin ≥25 g/L;
• Serum creatinine ≤133 μmol/L;
• PT and aPTT ≤ 1.5 × ULN; 6. Karnofsky score ≥ 60; 7. Expected survival \> 12 weeks; 8. Women of childbearing age\*: must use highly effective contraceptive methods (resulting in a contraceptive failure rate of \<1% per year) from the date of informed consent until at least 3 months after the last dose of the study drug fluzoparib/TMZ (whichever occurs later).
• Men: agree to use contraceptive measures, defined as follows: For female partners of childbearing potential or pregnant female partners, men must use highly effective contraceptive methods from the date of informed consent until at least 3 months after the last dose of the study drug fluzoparib/TMZ (whichever occurs later).

You may not qualify if:

• \. During the concurrent chemoradiotherapy phase, the total radiotherapy dose is \>60Gy; 2. Multifocal glioma (≥3 lesions); 3. Patients with primary infratentorial glioblastoma; 4. Patients with leptomeningeal disease; 5. Patients with stable or no dose reduction of corticosteroids within 14 days of randomization; 6. Pregnancy, lactation or breastfeeding (need to breastfeed or breastfeed during the study);
• HIV antibody positive;
• Active hepatitis B: defined as HBsAg positive or HBcAb positive, and HBV DNA test result \> 2000 IU/mL;
• Active hepatitis C: defined as HCV antibody positive and PCR test HCV RNA positive. However, subjects with positive serum anti-HCV and negative HCV RNA can also be included;
• Syphilis infection (positive Treponema pallidum specific antibody); 16. Patients who the investigator believes are not suitable for participation in the trial or will violate the protocol

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

fluzoparib; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 2, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share