Abstract | BACKGROUND: METHODS: In this open-label, multicenter study, olaparib tablets (62.5, 125, and 187.5 mg/m2 b.i.d.) will be administered orally in a standard 3 + 3 dose escalation design. Patients aged 3 to 18 years with recurrent pediatric solid tumors are eligible. Pharmacokinetic and pharmacodynamic analyses will also be performed. DISCUSSION: This study aims to extend the indications for olaparib by assessing its safety and efficacy in pediatric refractory solid tumor patients. TRIAL REGISTRATION: UMIN-CTR ( UMIN000025521 ); Registered on January 4, 2017.
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Authors | Masatoshi Takagi, Chitose Ogawa, Yuki Aoki-Nogami, Tomoko Iehara, Eri Ishibashi, Minoru Imai, Tetsuro Kihara, Kiyoshi Nobori, Kazuhisa Hasebe, Shuki Mizutani, Toshimi Kimura, Masashi Nagata, Masato Yasuhara, Kenichi Yoshimura, Pariko Yorozu, Hajime Hosoi, Ryuji Koike |
Journal | BMC pediatrics
(BMC Pediatr)
Vol. 19
Issue 1
Pg. 31
(01 26 2019)
ISSN: 1471-2431 [Electronic] England |
PMID | 30684955
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Phthalazines
- Piperazines
- Poly(ADP-ribose) Polymerase Inhibitors
- olaparib
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Topics |
- Administration, Oral
- Adolescent
- Child
- Child, Preschool
- Clinical Trials, Phase I as Topic
(methods)
- Humans
- Neoplasm Recurrence, Local
(drug therapy)
- Phthalazines
(administration & dosage)
- Piperazines
(administration & dosage)
- Poly(ADP-ribose) Polymerase Inhibitors
(administration & dosage)
- Research Design
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