Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Participants receive fluzoparil and temozolomide

fluzoparil

temozolomide

Jinming Yu, Ph.D, M.D

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.

A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma

6-months progression-free survival rate in all participants by RECIST 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.

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

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.

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.

mOS was defined as the time from the first day of study treatment to death due to any cause.

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.

Any event which causes death, permanent damage, birth defects, or requires hospitalization is considered an SAE.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma	NCT04552977	Glioblastoma	fluzoparil temozolomide	18 Years - 70 Years	Shandong Cancer Hospital and Institute
A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma	NCT04552977	Glioblastoma	fluzoparil temozolomide	18 Years - 70 Years	Shandong Cancer Hospital and Institute

Spots Global Cancer Trial Database for glioblastoma, fluzoparil