A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma
Reason given: Strategic decision
Key facts
- Where
- Durham and Jacksonville, United StatesSee the 2 sites
- Phase
- Phase 1
Where in United States
- Duke University HospitalDurham, United StatesNo longer taking part
- Baptist MD AndersonJacksonville, United StatesNo longer taking part
Trial details
- Who runs it
- Biodexa Pharmaceuticals
- Trial code
- NCT05324501
- Record updated
- 10 February 2025
- Original description
A study designed to assess the safety of MTX110 in patients suffering with recurrent glioblastoma. MTX110 will be administered directly to the site of the tumour via a catheter which is inserted during a surgical procedure at the beginning of the study.Read full original descriptionShow less
Phase I Open Label Ascending Dose Study to Assess the Feasibility and Safety of Intermittent Infusions of MTX110 Administered by Convection-Enhanced Delivery (CED) in Patients With Recurrent Glioblastoma (rGBM) (MAGIC-G1)
A study designed to assess the safety of MTX110 in patients suffering with recurrent glioblastoma. MTX110 will be administered directly to the site of the tumour via a catheter which is inserted during a surgical procedure at the beginning of the study.
Inclusion: Recurrent glioblastoma; Patients must be healthy enough to tolerate surgery and general anesthesia; Estimated life expectancy of greater than 3 months.
Exclusion: Patients scheduled to undergo or are undergoing re-irradiation for the recurrent tumour; Patients with a history of glioblastoma treatment with carmustine or Gliadel® wafers; Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks, or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week) prior to starting the study drug; Patients may not have received treatment with tumor treating fields ≤ 1 week prior to starting the study drug; Patients may not be less than 12 weeks from completion of radiation therapy for the primary tumor; Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active; multifocal disease; extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease; Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin (treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment); Patients who cannot undergo MRI; Posterior fossa location of the tumor, regardless of its morphology.