Entry Detail
| General information | |
| Database: | DB00902 |
| Objective: | Thisphase I, dosefinding study determined the maximum tolerated dose (MTD), safety, and pharmacokinetics of sunitinib plus gemcitabine in patients with advanced solid tumours |
| Authors: | Michaelson MD, et al |
| Title: | Sunitinib in combination with gemcitabine for advanced solid tumours: a phase I dosefinding study. |
| Journal: | Br J Cancer. |
| Year: | 2013 |
| PMID: | 23511559 |
| Trial Design | |
| Clinical Trial Id: | NCT00615446 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Sunitinib + gemcitabine |
| Study Type: | a phase I dosefinding study |
| Key Patients Feature: | The population comprised patients aged 18 years with life expectancy 12 weeks and Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. All patients had histologically proven advanced solid tumours for which curative therapy was not available, had received 1 prior chemotherapy regimen, and were considered eligible |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Two schedules with sunitinib (2550 mg per day) and IV gemcitabine (7501250 mg m(2)) in escalating doses were studied. First, patients received sunitinib on a 4weekson2weeksoff schedule (Schedule 4/2) plus gemcitabine on days 1, 8, 22, and 29. Second, patients received sunitinib on a 2weekson1weekoff schedule (Schedule 2/1) plus gemcitabine on days 1 and 8. |
| Primary End Point: | determination of MTD and tolerability |
| Secondary End Point: | NA |
| Patients Number: | 44 |
| Trial Results | |
| DLT_MTD: | With no doselimiting toxicities (DLTs) at maximum dose levels on Schedule 2/1, MTD was not reached. |
| Objective Response Rate: | 18% |
| 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): | Grade 4 treatmentrelated AEs and laboratory abnormalities included cerebrovascular accident, hypertension, and pulmonary embolism (n=1 each), and neutropenia (n=3), thrombocytopenia and increased uric acid (both n=2), and lymphopenia (n=1). There were no clinically significant drugdrug interactions. |
| Conclusions: | Sunitinib plus gemcitabine on Schedule 21 with growth factor support was well tolerated and safely administered at maximum doses of each drug, without significant drugdrug interactions. |