Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Cilengitide (2-times weekly)
cilengitide · 4 trials · 3 indications
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.
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC).
Cmax of cilengitide in plasma after single dose in groups of subjects with different grades of renal function compared to subjects with normal renal function.
AUC of cilengitide in plasma after single dose in groups of subjects with different grades of renal function compared to subjects with normal renal function.
| 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 | - |
| Safety run-in part: Cil (1000 mg) + Cetuximab + Cis + Gem | EXPERIMENTAL | - |
| Safety run-in part: Cil (1000 mg) + Cetuximab + Cis + Vin | EXPERIMENTAL | - |
| Safety run-in part: Cil (2000 mg) + Cetuximab + Cis + Gem | EXPERIMENTAL | - |
| Safety run-in part: Cil (2000 mg) + Cetuximab + Cis + Vin | EXPERIMENTAL | - |
| Randomized part: Cil (Once Weekly) + Cetuximab + Chemotherapy | EXPERIMENTAL | - |
| Randomized part: Cil (Twice Weekly) + Cetuximab + Chemotherapy | EXPERIMENTAL | - |
| Randomized part: Cetuximab + Chemotherapy | ACTIVE_COMPARATOR | - |
| Group 1 | EXPERIMENTAL | Healthy volunteers: matched subjects with normal renal function |
| Group 2 | EXPERIMENTAL | Mild renal impaired subjects |
| Group 3 | EXPERIMENTAL | Moderate renal impaired subjects |
| Group 4a | EXPERIMENTAL | First group of Severe renal impaired subjects |
| Group 4b | EXPERIMENTAL | Second group of severe renal impaired subjects |
| 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. |
| Cetuximab | DRUG | Cetuximab will be administered at a dose of 400 milligram per square meter (mg/m\^2) as intravenous infusion over 2 hours on Day 1. |
| Cisplatin | DRUG | Cisplatin (Cis) will be administered at a dose of 75 mg/m\^2 as intravenous infusion on Day 1. |
| Gemcitabine | DRUG | Gemcitabine (Gem) will be administered at a dose of 1250 mg/m\^2 as intravenous infusion on Days 1 and 8. |
| Vinorelbine | DRUG | Vinorelbine (Vin) will be administered at a dose of 25 mg/m\^2 as intravenous infusion on Days 1 and 8. |
| Chemotherapy | DRUG | Cis 80 mg/m\^2 intravenous infusion on Day 1 + Vin 25 mg/m\^2 or Cis 75 mg/m\^2 intravenous infusion on Day 1 + Gem 1250 mg/m\^2 intravenous infusion on Days 1 and 8 of each 3-week cycle will be administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles. |
| cilengitide 2000mg | DRUG | A single dose of cilengitide 2000mg (250mL) will be administered as 1-hour i.v. infusion on Day 1 |
| cilengitide 1000mg | DRUG | A single dose of cilengitide 1000mg (125mL) will be administered as 1-hour i.v. infusion on Day 1 |
| cilengitide > 1000mg and up to 2000mg | DRUG | A single dose of cilengitide \> 1000mg and up to 2000mg will be administered as 1-hour i.v. infusion on Day 1 if applicable, based on Safety Monitoring Committee decision |
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 oncology drug developed by Merck KGaA. It has been studied in non-small cell lung cancer, glioblastoma, and renal impairment. It is not approved and remains in clinical development, with completed Phase 1, Phase 2, and Phase 3 trials in these indications.
Cilengitide targets the integrins ITGB3, ITGAV, and ITGB5, where it acts as an antagonist. By blocking these integrin receptors, it interferes with integrin-mediated signaling in tumor cells and their surrounding environment. This integrin antagonist mechanism underlies its investigation as an anticancer agent in glioblastoma and non-small cell lung cancer.
Cilengitide is developed by Merck KGaA, which trades under the ticker MKGAF. Merck KGaA sponsored the clinical trials evaluating cilengitide in glioblastoma, non-small cell lung cancer, and renal impairment.
Cilengitide is in Phase 2 development overall, though a Phase 3 trial in glioblastoma has also been completed. It is investigational and not approved. The Phase 3 study NCT00689221 evaluated cilengitide with temozolomide and radiation in newly diagnosed glioblastoma patients with methylated gene promoter status.
Cilengitide has been studied in completed trials including NCT01504165, a Phase 1 pharmacokinetic study in renal impairment; NCT00842712, a Phase 2 trial with cetuximab and platinum chemotherapy in advanced non-small cell lung cancer; and NCT00813943 and NCT00689221, Phase 2 and Phase 3 glioblastoma trials combining cilengitide with temozolomide and radiation therapy.