Skip to content

Exploratory Clinical Study on Mifepristone for the Treatment of Recurrent Glioblastoma

Phase I Clinical Trials on Mifepristone for the Treatment of Recurrent Glioblastoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065595
Enrollment
Unknown
Registered
2022-11-09
Start date
2022-11-21
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Glioblastoma

Interventions

treatment group:Administration of Mifepristone

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The subject has histologically confirmed diagnosis of primary GBM for which the subject has received surgical intervention of GTR, and postoperative radiochemotherapy of standard Stupp protocol. 2. Clinical presentation consistent with recurrent glioblastoma with measurable enhancing lesions according to RANO criteria; 3. >=18 years of age; 4. Karnofsky performance status (KPS) >= 70; 5. Complete blood count: WBC>4 x 10^9/L, Hb>90g/L; 6. No serious liver or kidney function abnormalities; 7. No significant electrocardiographic abnormalities; 8. No immune system disorders, no history of long-term hormone use within 3 months prior to treatment, non-allergic; 9. Not participating in other clinical trials related to glioma treatment; 10. Consent to join the study, with an informed consent form signed by the patient or a proxy; good compliance and ability to accept follow-up visits and relevant examinations.

Exclusion criteria

Exclusion criteria: 1. Those with contraindications to the use of prostaglandins: e.g. glaucoma, asthma and allergy to prostaglandins 2. Pregnancy with IUD and suspected ectopic pregnancy. 3. Those who are undergoing long-term corticosteroid treatment at the same time. 4. Pregnancy planned within 6 months. 5. Recent use of ketoconazole, itraconazole, erythromycin and other drugs related to metabolism via CYP3A4.

Design outcomes

Primary

MeasureTime frame
complete blood count;liver function test;kidney function test;endocrine test;contrast-enhanced brain MR;

Countries

China

Contacts

Public ContactMao Ying

Department of NeurosurgeryHuashan Hospital, Fudan University, Shanghai

maoying@fudan.edu.cn+86 13801769152

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026