| General information |
| Database: | DB00934 |
| Objective: | Vascular endothelial growth factor (VEGF) receptormediated signaling contributes to ovarian cancer pathogenesis. Elevated VEGF expression is associated with poor clinical outcomes. they investigated ramucirumab, a fully human antiVEGFR2 antibody, in patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Primary endpoints were progression free survival at 6 months (PFS6) and confirmed objective response rate (ORR). |
| Authors: | Penson RT, et al |
| Title: | a phase II study of ramucirumab (IMC1121B) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. |
| Journal: | Gynecol Oncol. |
| Year: | 2014 |
| PMID: | 25016924 |
| Trial Design |
| Clinical Trial Id: | NCT00721162 |
| Agent: | ramucirumab
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | ovarian, primary peritoneal, or fallopian tube carcinoma |
| Cancer Subtype: | epithelial ovarian, primary peritoneal, or fallopian tube carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II study |
| Key Patients Feature: | Women who received more than and equal to 1 platinumbased chemotherapeutic regimen and had a platinumfree interval of <12 months with measurable disease were eligible. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received 8 mg/kg ramucirumab intravenously every 2 weeks. |
| Primary End Point: | progression free survival at 6 months (PFS6) and confirmed objective response rate (ORR |
| Secondary End Point: | NA |
| Patients Number: | 60 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 5.00% |
| Disease Control Rate: | 61.70% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.5 months (95% CI: 2.3-5.3) and the 6month PFS rate was 33.5% (95% CI: 21.0-46.4%) |
| Median OS A vs. C: | 11.1 months (95% CI: 8.3-17.0) |
| Adverse Event(agent arm): | The most common treatmentemergent adverse events (TEAE) considered at least possibly related to study drug were headache (65.0%; Grade 3/4 10.0%), fatigue (56.7%; Grade 3/4 3.3%), diarrhea (28.3%; Grade 3/4 1.7%), hypertension (25.0%; Grade 3/4 3.3%), and nausea (20.0%; Grade 3/4 0%) |
| Conclusions: | Although antitumor activity was observed, the predetermined efficacy endpoints were not met. |