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clinical study for pediatric patients with solid tumors that have come back after disappearing or that don’t respond to any treatment, designed to find the safest and most tolerable dose of nab ®-pacl...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-000144-26

clinical study for pediatric patients with solid tumors that have come back after disappearing or that don’t respond to any treatment, designed to find the safest and most tolerable dose of nab ®-paclitaxel and to asses the preliminary efficacy of the treatment

Femme et Homme

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Extrait

Phase I: determine the pediatric MTD/RP2D, safety and tolerability of nab-paclitaxel administered intravenously over 30min on Days 1, 8, and 15 of a 28-day cycle in patients ≥ 6 months and < 18 years old with recurrent or refractory solid tumors Phase II: assess the antitumor activity by the overall response rate (ORR) of nab-paclitaxel given at the RP2D in patients ≥ 6 months and ≤ 24 years old with several discrete recurrent or refractory solid tumor types including neuroblastoma, rhabdomyosarcoma and Ewing's sarcoma

Critère d'inclusion

  • recurrent or refractory solid tumor

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