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Phase 1 study of veliparib with carboplatin and weekly paclitaxel in Japanese patients with newly diagnosed ovarian cancer.
Nishio, Shin; Takekuma, Munetaka; Takeuchi, Satoshi; Kawano, Kouichirou; Tsuda, Naotake; Tasaki, Kazuto; Takahashi, Nobutaka; Abe, Masakazu; Tanaka, Aki; Nagasawa, Takayuki; Shoji, Tadahiro; Xiong, Hao; Nuthalapati, Silpa; Leahy, Terri; Hashiba, Hideyuki; Kiriyama, Tsukasa; Komarnitsky, Philip; Hirashima, Yasuyuki; Ushijima, Kimio.
Afiliação
  • Nishio S; Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
  • Takekuma M; Division of Gynecology, Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan.
  • Takeuchi S; Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Iwate, Japan.
  • Kawano K; Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
  • Tsuda N; Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
  • Tasaki K; Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
  • Takahashi N; Division of Gynecology, Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan.
  • Abe M; Division of Gynecology, Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan.
  • Tanaka A; Division of Gynecology, Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan.
  • Nagasawa T; Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Iwate, Japan.
  • Shoji T; Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Iwate, Japan.
  • Xiong H; AbbVie, North Chicago, Illinois, USA.
  • Nuthalapati S; AbbVie, North Chicago, Illinois, USA.
  • Leahy T; AbbVie, North Chicago, Illinois, USA.
  • Hashiba H; AbbVie GK, Tokyo, Japan.
  • Kiriyama T; AbbVie GK, Tokyo, Japan.
  • Komarnitsky P; AbbVie, North Chicago, Illinois, USA.
  • Hirashima Y; Division of Gynecology, Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan.
  • Ushijima K; Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka, Japan.
Cancer Sci ; 108(11): 2213-2220, 2017 Nov.
Article em En | MEDLINE | ID: mdl-28837250
This phase 1, open-label, dose-escalation study was conducted to determine the safety, tolerability, pharmacokinetics and preliminary efficacy of veliparib with carboplatin and weekly paclitaxel in Japanese women with newly diagnosed, advanced ovarian cancer. Patients received veliparib at 100 or 150 mg b.i.d. on days 1-21 with carboplatin (area under the concentration-time curve 6 mg/mL•min) on day 1 and paclitaxel 80 mg/m2 on days 1, 8 and 15 every 3 weeks for up to 6 21-day cycles. Dose escalation followed a 3 + 3 design to determine dose-limiting toxicities, maximum tolerated dose and the recommended phase 2 dose. Nine patients (median age 62 [range 27-72] years) received a median of 5 (range 3-6) cycles of treatment (3 at 100 mg, 6 at 150 mg). There were no dose-limiting toxicities. The most common adverse events of any grade were neutropenia (100%), alopecia (89%), peripheral sensory neuropathy (78%), and anemia, nausea and malaise (67% each). Grade 3 or 4 adverse events were associated with myelosuppression. Pharmacokinetics of carboplatin/paclitaxel were similar at both veliparib doses. Response, assessed in five patients, was partial in four and complete in one (objective response rate 100%). The response could not be assessed in four patients who had no measurable disease at baseline. The recommended phase 2 dose of veliparib, when combined with carboplatin/paclitaxel, is 150 mg b.i.d. Findings from this phase 1 trial demonstrate the tolerability and safety of veliparib with carboplatin/paclitaxel, a regimen with potential clinical benefit in Japanese women with ovarian cancer.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Benzimidazóis / Carboplatina / Paclitaxel Tipo de estudo: Diagnostic_studies Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias Ovarianas / Benzimidazóis / Carboplatina / Paclitaxel Tipo de estudo: Diagnostic_studies Limite: Adult / Aged / Female / Humans / Middle aged Idioma: En Ano de publicação: 2017 Tipo de documento: Article