Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00705016 | Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) | PHASE1 | COMPLETED | 184 | — | — | Oct 1, 2008 | Jun 1, 2013 | Apr 30, 2014 | 37 | Austria, Belgium +7 |
The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors \[RECIST\] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.
| Arm | Type | Description |
|---|---|---|
| Cilengitide 2000 mg once weekly+Cetuximab+5-FU+Cisplatin | EXPERIMENTAL | - |
| Cilengitide 2000 mg twice weekly+Cetuximab+5-FU+Cisplatin | EXPERIMENTAL | - |
| Cetuximab+5-FU+Cisplatin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Cilengitide 2000 mg once weekly | DRUG | Cilengitide 500 milligram (mg) will be administered as an intravenous infusion over 60 minutes, daily from Day 1 to 4 of the first week of each 3-week cycle, subsequently followed by 2000 mg dose of cilengitide on Day 8 and 15 of every cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received cilengitide 2000 mg once weekly until PD, unacceptable toxicity or withdrawal for any other reason. |
| Cilengitide 2000 mg twice weekly | DRUG | Cilengitide 2000 mg will be administered as an intravenous infusion over 60 minutes, twice weekly on Day 1, 4, 8, 11, 15, and 18 of each 3-week cycle for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants will receive cilengitide 2000 mg once weekly until PD, unacceptable toxicity or withdrawal for any other reason. |
| Cetuximab | DRUG | Cetuximab will be administered as 250 milligram per square meter (mg/m\^2) as infusion (initial starting dose of 400 mg/m\^2) on Day 1, 8 and 15 of each 3-week treatment cycle. Cetuximab will be administered for a total of 6 cycles (18 weeks) or until PD, unacceptable toxicity or withdrawal for any other reason. After 6 cycles, participants received Cetuximab 250 mg/m\^2 once weekly until PD, unacceptable toxicity or withdrawal for any other reason. |
| 5-fluorouracil (5-FU) | DRUG | 5-FU will be administered as an intravenous continuous infusion at a dose of 1000 mg/m\^2 daily from Day 1 to 4 of each 3-week treatment cycle. 5-FU will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first. |
| Cisplatin | DRUG | Cisplatin will be administered as an intravenous infusion over 60 minutes, at a dose 100 mg/m\^2 on Day 1 of each 3-week treatment cycle. Cisplatin will be administered for a total of 6 cycles (18 weeks), or until PD, unacceptable toxicity, or withdrawal for any other reason, whichever occur first. |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of SCCHN * At least one measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) * Karnofsky performance status (KPS) of greater than or equal to 70 or eastern cooperative oncology gro...