Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Semustine · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Temodal group | EXPERIMENTAL | Subjects treated with temozolomide. |
| Semustine group | ACTIVE_COMPARATOR | Subjects treated with semustine. |
| Name | Type | Description |
|---|---|---|
| Temozolomide | DRUG | Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy. |
| Semustine | DRUG | Semustine orally once every 28 days at a dose of 150 mg/m2/day. |
Inclusion Criteria: * Prior histologic confirmation of glioblastoma, anaplastic astrocytoma. * Evidence of tumor progression or recurrence. * Age \>=18 years. * Karnofsky performance status \>=60%. * Absolute neutrophil count \>=1,500/mm\^3, platelet count \>=100,000/mm\^3, hemoglobin \>=8g/dL. * S...
Semustine is an investigational small molecule being studied for the treatment of glioblastoma, a type of brain cancer. It is being evaluated in patients with recurrent glioblastoma or anaplastic astrocytoma. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.
Semustine is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with recurrent glioblastoma or anaplastic astrocytoma.
Semustine is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 3 trial has been completed, but the drug is not yet available for commercial use.
Semustine has been studied in one completed Phase 3 clinical trial with the identifier NCT00335075. The trial, titled 'Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)', enrolled 151 participants and compared Semustine to an active control.
No, Semustine is not the same as Temodal. In the clinical trial NCT00335075, Semustine was compared against Temodal (temozolomide) as an active control. Semustine is a separate investigational drug being studied for recurrent glioblastoma or anaplastic astrocytoma.