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

Official Title

A Phase 1/2, Multicentre, 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 Tumours.

Summary:

The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumours, and to see if it works to treat these solid tumours 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 tumour type, (neuroblastoma, rhabdomyosarcoma, or Ewing's sarcoma), to see how nab-paclitaxel works in treating these tumours.

Trial Description

Primary Outcome:

  • Incidence of Dose Limiting Toxicities (DLT) (Phase 1)
  • Incidence of adverse events (Phase 1)
  • Overall response rate (ORR) (Phase 2)
Secondary Outcome:
  • Pharmacokinetics (PK) - Cmax (Phase 1)
  • Pharmacokinetics (PK) - AUC (Phase 1)
  • Pharmacokinetics (PK) - Clearance (Phase 1)
  • Pharmacokinetics (PK) - Vss (Phase 1)
  • Overall Response Rate (ORR) (Phase 1)
  • Duration of Response (DOR)
  • Disease Control Rate (DCR)
  • Progression-free survival (PFS)
  • 1-year survival
  • Safety
  • Pharmacokinetics (PK) -Cmax (Phase 2)
  • Pharmacokinetics (PK) - AUC (Phase 2)
  • Pharmacokinetics (PK) - Clearance (Phase 2)
  • Pharmacokinetics (PK) - Vss (Phase 2)
ABI-007-PST-001 is a Phase 1 / 2, multicentre, 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 tumours (excluding brain tumours). 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 tumour groups [Neuroblastomas, Rhabdomyosarcomas, Ewing's Sarcomas]. Both phases of the study are open-label and conducted at multiple centres. 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.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society