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  • Title: A phase ib study of safety and pharmacokinetics of ramucirumab in combination with paclitaxel in patients with advanced gastric adenocarcinomas.
    Author: Ueda S, Satoh T, Gotoh M, Gao L, Doi T.
    Journal: Oncologist; 2015 May; 20(5):493-4. PubMed ID: 25888272.
    Abstract:
    LESSONS LEARNED: The pharmacokinetic results of this phase Ib study of ramucirumab combined with paclitaxel as second-line therapy in Japanese patients with metastatic gastric or gastro-esophageal junction adenocarcinoma are in line with previous ramucirumab studies.This combination at the doses and schedule given did not result in any dose-limiting toxicities and appeared to be safe and well tolerated. BACKGROUND: This phase Ib study evaluated the tolerability and pharmacokinetics of ramucirumab, an anti-VEGFR-2 antibody, combined with paclitaxel as second-line therapy in Japanese patients with metastatic gastric or gastroesophageal junction adenocarcinoma after first-line therapy with fluoropyrimidines and/or platinum. METHODS: Patients received ramucirumab 8 mg/kg on days 1 and 15 and paclitaxel 80 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. Safety analyses included all patients (n = 6). RESULTS: No dose-limiting toxicities occurred in the first cycle. All patients experienced ≥1 treatment-emergent adverse event (TEAE); 5 patients experienced grade ≥3 TEAEs. There were two deaths caused by disease progression. The best overall responses were stable disease (n = 5) and partial response (n = 1). Patients received ramucirumab and paclitaxel for a median of 12.5 weeks (range: 11.4-42.7 weeks) and 12.2 weeks (range: 11.0-41.0 weeks), respectively. Following a single dose of ramucirumab IV infusion 8 mg/kg, clearance was ∼0.017 L/hour, half-life (t1/2) was 138 to 225 hours, and steady-state volume of distribution (Vss) was ∼3 L. CONCLUSION: The ramucirumab/paclitaxel combination appears to be well-tolerated in Japanese patients with advanced gastric adenocarcinomas. These results are in line with previous ramucirumab pharmacokinetic studies as anticipated. 摘要 背景. 本项Ib期研究纳入了患有转移性胃腺癌或胃食管交界部腺癌的日本患者，评价了抗VEGFR-2抗体雷莫芦单抗联合紫杉醇作为氟尿嘧啶和/或铂类一线治疗失败后的二线治疗的耐受性和药代动力学特征。 方法. 给予患者雷莫芦单抗8 mg/kg（第1、15天）和紫杉醇80 mg/m2（第1、8、15天）治疗，28天为一周期。安全性分析纳入了所有患者（n = 6）。 结果. 第一个周期中未发生剂量限制毒性事件。所有患者均发生≥ 1次治疗后出现的不良事件（TEAE），5例患者发生了≥ 3级TEAE。2例患者死于疾病进展。最佳总体治疗反应为疾病稳定（n = 5）和部分缓解（n = 1）。中位治疗时间分别为雷莫芦单抗12.5周（范围：11.4 ∼ 42.7周）和紫杉醇12.2周（范围：11.0 ∼ 41.0周）。单次静脉注射雷莫芦单抗8 mg/kg后，清除率约为0.017 L/小时，半衰期（t1/2）为138 ∼ 225小时，稳态分布容积（VSS）约为3 L。 结论. 雷莫芦单抗联合紫杉醇方案在日本进展期胃腺癌患者中耐受良好。如同预期，这些结果与既往雷莫芦单抗药代动力学研究的结果一致。The Oncologist 2015;20:493–494
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