Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gadolinium · 1 trial · 2 indications
Dose limiting toxicities (DLTs) are defined as possibly, probably, or definitely related adverse events that are severe or medically significant, and needing topical \& systemic therapy; needing surgery intervention; needing hospitalization; needing treatment interruption; or life threatening. Late DLTs will be assessed as the number of DLTs that occur in the period from 31 days after the start of treatment through 5 months after the start of treatment. The outcome will be reported as a number without dispersion.
| Arm | Type | Description |
|---|---|---|
| Novo-TTF | EXPERIMENTAL | Day 1: Subjects will wear the Optune (TTFields device) for ≥ 18 hours/day. They will take off the device when receiving stereotactic radiosurgery and brain MRI scans. Days 1 to 8: Subjects will take oral temozolomide 75 mg/m2/day Days 2 to 8: Subjects will receive stereotactic radiosurgery (total of 35 Gy) divided equally over 5 days • After the interventional treatment, subjects will receive standard of care adjuvant chemotherapy and routine surveillance brain MRI scans. |
| Name | Type | Description |
|---|---|---|
| Optune | DEVICE | Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure |
| Gadolinium | DRUG | Gadolinium contrast medium |
| Temozolomide | DRUG | Chemotherapy agent |
| Stereotactic radiosurgery (SRS) | RADIATION | Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2 |
Inclusion Criteria: * Histopathologically proven newly diagnosed glioblastoma (GBM, WHO Grade IV) or molecular GBM of lower grade that will be treated as per glioblastoma (defined as IDH wild type, 1p19q not co deleted) * Age ≥ 18 years * A maximum tumor target diameter of less than 5 cm on the pos...
Gadolinium is an investigational small molecule being studied for use in glioblastoma, a type of brain cancer. It is being evaluated in combination with Tumor Treating Fields and hypofractionated chemoradiotherapy for newly diagnosed glioblastoma. The drug is currently in Phase 1 clinical development and is not yet approved.
Gadolinium is being developed by NovoCure Limited, a company traded on NASDAQ under the ticker NVCR. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with glioblastoma.
Gadolinium is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial for glioblastoma has been completed.
Gadolinium has been studied in one clinical trial, identified as NCT04474353. This Phase 1 trial, titled 'Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma,' enrolled 12 participants in the United States. The trial has been completed.
Gadolinium is being developed by NovoCure Limited as a small molecule for glioblastoma. While gadolinium-based compounds are commonly known as MRI contrast agents, this specific drug is being investigated for its potential role in cancer treatment, not as a diagnostic imaging agent.