Entry Detail
| General information | |
| Database: | DB00887 |
| Objective: | To establish the safety, pharmacokinetics, and recommended dose of sunitinib, a novel oral multitargeting tyrosine kinase inhibitor with antiangiogenic and antitumor properties, in patients with advanced malignancies |
| Authors: | Faivre S, et al |
| Title: | Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. |
| Journal: | J Clin Oncol. |
| Year: | 2006 |
| PMID: | 16314617 |
| Trial Design | |
| Clinical Trial Id: | NA |
| 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: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | phase I doseescalation study |
| Key Patients Feature: | Patients with histologically proven advanced solid malignancy for which no other therapy was possible, with an Eastern Cooperative Oncology Group performance status less than and equal to 2, were included in the study. Eligible patients were women (postmenopausal, surgically sterile, or using effective contraception) or men more than and equal to 18 years of age with adequate bone marrow, liver, and renal function |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Sunitinib was given orally for 4 weeks every 6 weeks |
| Primary End Point: | safety, pharmacokinetics, and recommended dose |
| Secondary End Point: | NA |
| Patients Number: | 28 |
| Trial Results | |
| DLT_MTD: | Hematologic doselimiting toxicity (DLT) was defined as at least a grade 4 hematologic toxicity or grade 3 thrombocytopenia accompanied by a grade 3 or greater hemorrhage.The MTD was defined as the dose level at which less than 33% of the patients would experience DLT at cycle 1 |
| 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): | Asthenia was the most frequent grade 3 to 4 toxicity at doses more than and equal to 50 mg/d. Asthenia appeared progressively from grade 1 during the first 2 weeks and worsened slightly to grade 3 to 4 during weeks 3 and 4 of each cycle. |
| Conclusions: | At the dose of 50 mgd (4 weeks on, 2 weeks off), sunitinib displays manageable toxicity. Antitumor activity supports further studies in patients with renal cell carcinoma, gastrointestinal, neuroendocrine, and stromal tumors. Future studies may consider including prospective imaging techniques such as high frequency ultrasound to monitor tumor density. |