Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cilengitide · 2 trials · 1 indication
The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
| Arm | Type | Description |
|---|---|---|
| Cilengitide + Temozolomide + Radiotherapy | EXPERIMENTAL | - |
| Temozolomide + Radiotherapy | ACTIVE_COMPARATOR | - |
| Cilengitide (2-times weekly) + Temozolomide + Radiotherapy | EXPERIMENTAL | - |
| Cilengitide (5-times weekly) + Temozolomide + Radiotherapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cilengitide | DRUG | Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. |
| Temozolomide | DRUG | Temozolomide (TMZ) 75 milligram per square meter \[mg/m\^2\] will be administered intravenously once daily from Weeks 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m\^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression. |
| Radiotherapy | RADIATION | Radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Weeks 1 to 6, total dose 60 Gy. |
| Cilengitide (2-times weekly) | DRUG | Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. |
| cilengitide (5-times weekly) | DRUG | Cilengitide 2000 milligram (mg) will be administered intravenously 5-times weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment. |
Inclusion Criteria: 1. Tumor tissue specimens from the glioblastoma surgery or open biopsy (formalin-fixed, paraffin-embedded block; stereotactic biopsy not allowed) must be available for MGMT status analysis and central pathology review 2. Newly diagnosed histologically proven supratentorial gliob...
Cilengitide is an investigational small molecule being studied for the treatment of glioblastoma, a type of brain cancer. It is administered in combination with temozolomide and radiation therapy in patients with newly diagnosed glioblastoma, with treatment approaches varying based on the methylation status of the gene promoter.
Cilengitide is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company has sponsored clinical trials evaluating the drug in patients with glioblastoma.
Cilengitide has completed Phase 3 clinical development for glioblastoma. It remains an investigational drug and is not approved by regulatory authorities. Two clinical trials have been completed, including one Phase 3 study and one Phase 2 study, with a total enrollment of 810 patients.
Cilengitide has been evaluated in two completed clinical trials. NCT00689221 is a Phase 3 study in patients with newly diagnosed glioblastoma and methylated gene promoter status, enrolling 545 participants. NCT00813943 is a Phase 2 study in patients with unmethylated gene promoter status, enrolling 265 participants. Both trials combined cilengitide with temozolomide and radiation therapy.
Cilengitide is a small molecule that targets integrins, which are cell surface receptors involved in tumor growth and angiogenesis. By inhibiting these integrins, cilengitide aims to disrupt the interactions between tumor cells and their microenvironment, potentially slowing tumor progression in glioblastoma.
Cilengitide is the sole name provided for this investigational drug. It is not known by any alternative names in the available information. The drug is being studied specifically for glioblastoma and has no other documented names or aliases.