Phase I clinical study of oral olaparib in pediatric patients with refractory solid tumors: study protocol

被引：8

作者：

Takagi, Masatoshi ^{[1
]}

Ogawa, Chitose ^{[2
]}

Aoki-Nogami, Yuki ^{[2
]}

Iehara, Tomoko ^{[3
]}

Ishibashi, Eri ^{[4
]}

Imai, Minoru ^{[4
]}

Kihara, Tetsuro ^{[4
]}

Nobori, Kiyoshi ^{[5
]}

Hasebe, Kazuhisa ^{[4
]}

Mizutani, Shuki ^{[4
]}

Kimura, Toshimi ^{[6
]}

Nagata, Masashi ^{[7
]}

Yasuhara, Masato ^{[7
]}

Yoshimura, Kenichi ^{[8
]}

Yorozu, Pariko ^{[5
]}

Hosoi, Hajime ^{[3
]}

Koike, Ryuji ^{[5
]}

机构：

[1] Tokyo Med & Dent Univ, Dept Pediat & Dev Biol, Bunkyo Ku, Yushima 1-5-45, Tokyo 1138519, Japan

[2] Natl Canc Ctr, Dept Pediat Oncol, Chuo Ku, Tsukiji 5-1-1, Tokyo 1040045, Japan

[3] Kyoto Prefectural Univ Med, Dept Pediat, Kamigyo Ku, Kyoto 6028566, Japan

[4] Tokyo Med & Dent Univ, Univ Res Adm Div, Tokyo, Japan

[5] Tokyo Med & Dent Univ, Med Innovat Promot Ctr, Tokyo, Japan

[6] Tokyo Womens Med Univ, Dept Pharmacodynam, Shinjuku Ku, Kawada Cho 8-1, Tokyo 1628666, Japan

[7] Tokyo Med & Dent Univ, Dept Pharmacodynam, Tokyo, Japan

[8] Kanazawa Univ, Innovat Clin Res Ctr, Takara Machi 13-1, Kanazawa, Ishikawa 9208641, Japan

来源：

BMC PEDIATRICS | 2019年 / 19卷 / 1期

关键词：

Olaparib; Phase I; Children; Solid tumor; Chemotherapy; Poly(ADP-ribose) polymerase; TABLET FORMULATION; SURVIVAL; OSTEOSARCOMA; RECURRENCE; CHILDREN; RELAPSE; REPAIR; 11Q; TOLERABILITY; ADOLESCENTS;

D O I：

10.1186/s12887-019-1409-7

中图分类号：

R72 [儿科学];

学科分类号：

100202 ;

摘要：

BackgroundThere is no established standard chemotherapy for recurrent pediatric solid tumors such as neuroblastoma and sarcoma. Since some of these tumor cells show dysfunctions in homologous recombination repair, the goal is to conduct a phase I study of olaparib, a poly(ADP-ribose) polymerase inhibitor. In this clinical trial, the aims are to evaluate the safety, tolerability, and efficacy of olaparib in pediatric patients with refractory solid tumors and to recommend a dose for phase II trials.MethodsIn this open-label, multicenter study, olaparib tablets (62.5, 125, and 187.5mg/m(2) b.i.d.) will be administered orally in a standard 3+3 dose escalation design. Patients aged 3 to 18years with recurrent pediatric solid tumors are eligible. Pharmacokinetic and pharmacodynamic analyses will also be performed.DiscussionThis study aims to extend the indications for olaparib by assessing its safety and efficacy in pediatric refractory solid tumor patients.Trial registrationUMIN-CTR (UMIN000025521); Registered on January 4, 2017.

引用

页数：7

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