Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
fotemustine · 2 trials · 2 indications
Overall survival (OS) was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of magnetic resonance imaging (MRI) assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.
OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.
The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD.
| Arm | Type | Description |
|---|---|---|
| Calibration Arm | EXPERIMENTAL | - |
| Investigational Arm | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| bevacizumab [Avastin] | DRUG | 10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity |
| fotemustine | DRUG | 75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity |
Inclusion Criteria: * Adult patients, \>/=18 years of age * Diagnosis of recurrent glioblastoma multiforme (Grade IV) * Previous treatment with temozolomide and radiotherapy * First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy) * Adequate hematolo...
Fotemustine is an investigational small molecule being studied for the treatment of glioblastoma multiforme and malignant melanoma. It is in Phase 2 clinical development and has not been approved by the FDA. Fotemustine is being evaluated in combination with bevacizumab in clinical trials for these oncology indications.
Fotemustine is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials of fotemustine in combination with bevacizumab for the treatment of malignant melanoma and glioblastoma multiforme.
Fotemustine is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials of fotemustine have been completed, one in malignant melanoma and one in recurrent glioblastoma.
Fotemustine has been studied in two completed Phase 2 clinical trials. NCT01069627 evaluated fotemustine with bevacizumab in 20 patients with metastatic melanoma in Italy. NCT01474239 evaluated fotemustine with bevacizumab in 91 patients with recurrent glioblastoma in Italy.
Fotemustine is a small molecule oncology drug. Its specific molecular target has not been disclosed in the available information. It is being studied in combination with bevacizumab for the treatment of malignant melanoma and glioblastoma multiforme.