Entry Detail
| General information | |
| Database: | DB00835 |
| Objective: | The primary objective of thisphase I doseescalation study was to identify the maximum tolerated dose (MTD) of sunitinib plus pemetrexed in patients with advanced cancer. |
| Authors: | Chow LQ, et al |
| Title: | a phase I doseescalation and pharmacokinetic study of sunitinib in combination with pemetrexed in patients with advanced solid malignancies, with an expanded cohort in non small cell lung cancer. |
| Journal: | Cancer Chemother Pharmacol. |
| Year: | 2012 |
| PMID: | 21989766 |
| Trial Design | |
| Clinical Trial Id: | NCT00528619 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | sunitinib + pemetrexed |
| Study Type: | a phase I doseescalation and pharmacokinetic study |
| Key Patients Feature: | Male or female patients, 18 years or older, with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 were considered for study entry into the original cohort. patients were eligible if they had a diagnosis of a solid malignancy that was histologically or cytopathologically confirmed and refractory to standard therapy, or for which no standard therapy existed. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Using a 3 + 3 doseescalation design, patients received oral sunitinib qd by continuous daily dosing (CDD schedule; 37.5 or 50 mg) or 2 weeks on/1 week off treatment schedule (Schedule 2/1; 50 mg). Pemetrexed (300500 mg/m(2) IV) was administered q3w. At the proposed recommendedphase 2 dose (RP2D), additional patients with non small cell lung cancer (non small cell lung cancer) were enrolled. |
| Primary End Point: | the maximum tolerated dose (MTD) |
| Secondary End Point: | NA |
| Patients Number: | 35 |
| Trial Results | |
| DLT_MTD: | MTDs were sunitinib 37.5 mg/day (CDD/RP2D) or 50 mg/day (Schedule 2/1) with pemetrexed 500 mg/m2. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common nonhematologic AEs related to either drug, observed in patients treated on the CDD schedule MTD, were fatigue/asthenia (n = 16; 73%), nausea (n = 14; 64%), and anorexia (n = 13; 59%). |
| Conclusions: | In patients with advanced solid malignancies, the MTD of sunitinib plus 500 mg/m(2) pemetrexed was 37.5 mgday (CDD schedule) or 50 mgday (Schedule 21). The CDD schedule MTD was tolerable and demonstrated promising clinical benefit in non small cell lung cancer |