Entry Detail
| General information | |
| Database: | DB00369 |
| Objective: | Foretinib is a smallmolecule, oral multikinase inhibitor primarily targeting the mesenchymal epithelial transition (MET) factor receptor, and the vascular endothelial growth factor receptor 2. They conducted a phase II study to evaluate the singleagent activity and tolerability of foretinib in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). |
| Authors: | Seitheyrt T, et al |
| Title: | Phase II trial of singleagent foretinib (GSK1363089) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. |
| Journal: | Invest New Drugs. |
| Year: | 2013 |
| PMID: | 22918720 |
| Trial Design | |
| Clinical Trial Id: | NCT00725764 |
| Agent: | foretinib |
| Target: | Vascular endothelial growth factor receptor 2 Hepatocyte growth factor receptor |
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | singlearm, phase II, multicenter¡¡nonrandomized, openlabel, Simon IIstagesafety and efficacy study |
| Key Patients Feature: | recurrent/metastatic squamous cellcarcinoma of the head and neck (SCCHN). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Foretinib was administered as 240 mg orally for 5 consecutive days of a 14day treatment cycle (5/9 schedule) to patients with recurrent and/or metastatic SCCHN. |
| Primary End Point: | the response rate according to RECIST 1.0; |
| Secondary End Point: | progression free survival (PFS), duration of response, overall survival (OS) and the pharmacokinetic parameters. |
| Patients Number: | 41 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Although there were no confirmed PRs or CRs in this trial, seven of 14 patients had stable disease (SD)and six of 14 patients experienced some tumor shrinkage (range 5-21 %).The median duration of SD was 4.1 months and the disease stabilization rate was 50 % (Table 3). Two patients had prolonged SD of 13 and 13.9 months¡¯ duration, respectively.The median duration of SD was 4.1 months and the disease stabilization rate was 50 % (Table 3). Two patients had prolonged SD of 13 and 13.9 months¡¯ duration, respectively. |
| Disease Control Rate: | 0.5 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.65 months (3.4-5.3) |
| Median OS A vs. C: | 5.59 months (3.71-NA) |
| Adverse Event(agent arm): | The most common adverse events were fatigue, constipation and hypertension, which were manageable with additional medication or adjustments to the dosing schedule. |
| Conclusions: | Foretinib 240 mg on a 59 schedule was generally well tolerated. SD was the bestobserved outcome, with minor tumor shrinkage detected in nearly half of all patients. The efficacy results, prolonged disease stabilization and tolerable sideeffect profile, support further investigation, possibly in combination with other targeted agents or cytotoxic chemotherapy for SCCHN. |