| General information |
| Database: | DB00937 |
| Objective: | Multitargeted tyrosine kinase inhibitors (TKIs) have antitumor activity in metastatic renal cell carcinoma (mRCC). Resistance to these agents develops frequently, and their use is often limited by intolerance. Ramucirumab is a recombinant human monoclonal antibody directed against human vascular endothelial growth factor receptor2. For this study, the authors investigated the clinical efficacy and safety of ramucirumab in patients with TKIresistant/intolerant mRCC |
| Authors: | Garcia JA, et al |
| Title: | a phase 2, singlearm study of ramucirumab in patients with metastatic renal cell carcinoma with disease progression on or intolerance to tyrosine kinase inhibitor therapy. |
| Journal: | Cancer. |
| Year: | 2014 |
| PMID: | 24577874 |
| Trial Design |
| Clinical Trial Id: | NCT 00515697 |
| Agent: | ramucirumab
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II, singlearm study |
| Key Patients Feature: | patients with metastatic renal cell carcinoma with disease progression on or intolerance to tyrosine kinase inhibitor therapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients received ramucirumab 8 mg/kg every 2 weeks until they developed disease progression or intolerable toxicity |
| Primary End Point: | the best objective response rate (ORR); |
| Secondary End Point: | the disease control rate (DCR), progression free survival (PFS), the median duration of overall response, and safety. |
| Patients Number: | 39 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 5.10% |
| Disease Control Rate: | The 12week DCR was 64.1% (95% CI, 47.2%78.8%). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 7.1 months (95% CI, 4.19.7 months) |
| Median OS A vs. C: | 24.8 months (95% CI, 18.932.6 months) |
| Adverse Event(agent arm): | AEs that resulted in dose modifications/delays in >1 patient were proteinuria (n = 3), acute renal failure (n = 2), hemoptysis (n = 2), hypertension (n = 2), increased blood creatinine (n = 2), and infusion reaction (n = 2). Overall, 37 patients (94.9%) experienced a drugrelated AE, defined as an event that was considered possibly, probably, or definitely related to investigational therapy. Of these, 10 patients (25.6%) experienced a grade 3 or 4 AE. The most common drugrelated AEs were fatigue (35.9%; 2.6% grade 3), headache (33.3%; 2.6% grade 3), and epistaxis (30.8%; 0% grade 3). The incidence of hypertension was 15.4% (7.7% grade 3) |
| Conclusions: | Although the study did not meet its primary endpoint of more than and equal to 15% ORR, ramucirumab was associated with evidence of antitumor activity in patients with TKIresistantintolerant mRCC. Ramucirumab was safe and well tolerated. |