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Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy

NCT01222767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-10-29

Study results available
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Summary

This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis® (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the antitumor activity of Zalypsis.

Conditions

  • Ewing's Sarcoma
  • Primitive Neuroectodermal Tumor (PNET)
  • Askin's Tumor of the Chest Wall
  • Extraosseous Ewing's Sarcoma (EOE)

Interventions

DRUG

Zalypsis

Zalypsis is provided as a lyophilized powder for concentrate for solution for infusion in a strength of 2.5 mg/vial.

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Principal Investigators

  • Fariba Navid, MD · St. Jude Children 's Research Hospital

  • Sant P Chawla, MD · Sarcoma Oncology Center

  • Jean Yves Blay, MD · Centre Leon Berard

  • Stefano Ferrari, MD · Istituto Ortopedici Rizzoli

  • Armando Santoro, Prof. · Istituto Clinico Humanitas

  • Paolo Casali, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  • Robin L. Jones, MD · Seattle Cancer Care Alliance

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222767 on ClinicalTrials.gov