ＮＡＮＯ ＭＲＮＡ(株)【4571】の掲示板 2017/11/18〜2017/12/10

>>484

Clinical Trialsサイトではありませんので、推移は分かりません。

>>484

青えんぴつさん
いつも情報の提供をありがとうございます。

翻訳機で調べましたら、、、

高度な固体の腫瘍を持つ患者のNC-6004（ナノ粒子シスプラチン）
プラスGemcitabineのフェーズIb/IIトライアル

と訳されました。

>>484

若干、数値で異なるものもありますが、恐らく
平成29 年10 ⽉17 ⽇のIRと同じものだと思います。
　http://xml.irpocket.com/C4571/20171017WCLPRR.pdf

じものだと思います。

2017年4月19日受信。
改定は2017年7月19日を受けた。
受け入れ2017年10月10日
©2017米国癌研究協会

Abstract

Purpose: NC-6004, a novel cisplatin nanoparticle developed using micellar technology exhibits sustained release of cisplatin and selective distribution to tumors. Preclinical data demonstrated a favorable tolerability profile and preserved or improved antitumor activity compared with cisplatin across animal models. We evaluated the safety and tolerability of NC-6004 and gemcitabine using a Bayesian continual reassessment model (N-CRM) to determine the optimal dose.

Experimental Design: Patients with advanced solid tumors received NC-6004 at 60 to 180 mg/m2 on day 1 and gemcitabine at 1,250 mg/m2 on days 1 and 8 every 3 weeks. Dose escalation of NC-6004 began with a single patient run-in until a dose-limiting toxicity occurred at 180 mg/m2. Cohorts of four patients were enrolled at doses predicted by the N-CRM. The maximum tolerated dose (MTD) was defined as having the greatest probability of target toxicity <25%. Quality of life was assessed using EORTC-QLQ-C30.

Results: Among 22 patients, the most common grade III/IV hematologic adverse events were leukopenia (68%) and thrombocytopenia (59%). Of 20 pretreated patients evaluable for response, half were previously exposed to a platinum agent. The MTD was 135 mg/m2. Nine patients were treated at the MTD with median treatment duration of 15 weeks (range, 3–50). Tumor shrinkage occurred in 11 (55%), partial responses in 3 (15%), and stable disease in 14 (70%). Most patients reported stable or improved EORTC QLQ-C30 scores.

Conclusions: Greater cisplatin equivalent doses were achieved with no clinically significant neuro-, oto-, or nephrotoxicity. These data demonstrate tolerability and promising activity of NC-6004 in combination with gemcitabine. Clin Cancer Res; 1–9. ©2017 AACR.