Last updated on April 2018

To Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors

Brief description of study

The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in phase 1 18 years old and in phase 2 24 years old). After the final dose has been chosen, patients will be enrolled according to the specific solid tumor type, (neuroblastoma, rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these tumors.

Detailed Study Description

ABI-007-PST-001 is a Phase 1 / 2, multicenter, open-label, dose-finding study to assess the safety , tolerability, and preliminary efficacy of weekly nab-paclitaxel in pediatric patients with recurrent or refractory solid tumors (excluding brain tumors). The Phase 1 portion of the study, with a dose escalation design, ended and the recommended Phase 2 dose (RP2D) was determined as 240 mg/m2 IV in patients weighing > 10 kg and 11.5 mg/kg in patients weighing 10 kg on Days 1, 8 and 15 of a 28-day cycle . The Phase 2 portion of the study will enroll additional patients at the RP2D into one of three solid tumor groups [Neuroblastomas, Rhabdomyosarcomas, Ewing's Sarcomas]. Both phases of the study are open-label and conducted at multiple centers.

The Phase 2 is using a Simon two-stage design to monitor patient enrollment for each group separately. The Rhabdomyosarcoma group did not reach the expected number of two responders out of fourteen efficacy eligible patients. Consequently, this group is stopped.

Clinical Study Identifier: NCT01962103

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Phoenix Childrens Hospital
Phoenix, AZ United States

Columbia University Medical Center
New York, NY United States

The Hospital for Sick Children
Toronto, ON Canada

Institute for Pediatric Hemato-Oncology, Leon Berard Cancer Center
Lyon, France

Hopital d'Enfants, CHU Nancy
Nancy, France

Institut Curie
Paris, France

Institut Gustave Roussy
Villejuif, France

Azienda Ospedaliera Universitaria Meyer
Firenze, Italy

Children's Hospital Largo
Genova, Italy

Istituto Nazionale Tumori
Milan, Italy

Clinica di Oncoematologia
Padova, Italy

Policlinico Agostino Gemelli
Rome, Italy

l'Azienda Ospedaliera Regina Margherita - Sant Anna
Torino, Italy

Hospital Universitario Vall D Hebron
Barcelona, Spain

Hospital Sant Joan de Deu
Barcelona, Spain

Spanish National Cancer Research Centre
Madrid, Spain

Hospital Universitario Virgen Del Rocio
Sevilla, Spain

Unidad de Oncologia Pediatrica, Hospital Universitario la Fe
Valencia, Spain

Universit ts-Kinderklinik
Zurich, Switzerland

Royal Marsden Hospital
Sutton, United Kingdom