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

NCT04552977 | Unknown Phase 2 DMC

• 1 other identifier: GBM-IIT-SHR3162-TMZ
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glioblastoma

Keywords

glioblastoma, fluzoparil

Outcome Measures

Primary Outcomes (1)

• 6-months PFS rate in all participants by RECIST 1.1

  6-months progression-free survival rate in all participants by RECIST 1.1

  Up to approximately 24 months

Secondary Outcomes (7)

• ORR in all paients by RECIST Version 1.1

  Up to approximately 24 months

• Disease control rate in all patients by RECIST Version 1.1

  Up to approximately 24 months

• Overall survival (OS) in all participants

  Up to approximately 24 months

• mPFS in all participants

  Up to approximately 24 months

• mOS in all participants

  Up to approximately 24 months

Study Arms (1)

fluzoparil+temozolomide

EXPERIMENTAL

Participants receive fluzoparil and temozolomide

Drug: fluzoparil; Drug: temozolomide

Interventions

fluzoparil DRUG

a PARP1 inhibitor

fluzoparil+temozolomide

temozolomide DRUG

an alkylating chemotherapeutic agent

fluzoparil+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:

• 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;
• 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);

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

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 Officials

• Jinming Yu, Ph.D, M.D

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinming Yu, Ph.D, M.D

CONTACT

13806406293; sdyujinming@126.com

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: President of Shandong Cancer Hospital and Institute

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 17, 2020
• Study Start: September 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share