Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cilengitide · 2 trials · 2 indications
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 |
|---|---|---|
| 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 (Cil) will be administered at a dose of 1000 milligram (mg) as intravenous infusion twice weekly over 1 hour on Days 1 and 4. |
| 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. Written informed consent obtained before undergoing any study-related activities. 2. Male or female, at least 18 years of age 3. Histologically confirmed NSCLC, Stage IIIb with documented malignant pleural effusion or Stage IV (according to staging system 6th edition) 4. EGFR...
Cilengitide is an investigational small molecule being studied for the treatment of carcinoma, non-small-cell lung cancer, and for use in patients with renal impairment. It is not approved and remains in clinical development.
Cilengitide is being developed by Merck KGaA, a biopharmaceutical company. The company's stock is traded under the ticker MKGAF.
Cilengitide is in Phase 2 clinical development for non-small-cell lung cancer. It has completed a Phase 1 study in renal impairment. The drug is investigational and has not been approved.
Cilengitide has been studied in two completed trials. NCT00842712 was a Phase 2 study in 232 patients with advanced non-small-cell lung cancer. NCT01504165 was a Phase 1 pharmacokinetic study in 32 subjects with renal impairment.
Cilengitide is the sole name provided for this investigational agent. No alternative names have been reported for this compound in the available clinical trial information.