At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
Zalypsisdrug
Likely dose
Zalypsis 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Zalypsis for Ewing's Sarcoma and 3 related conditions. Completed, enrolled 17 participants across 7 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEwing's Sarcoma, Primitive Neuroectodermal Tumor (PNET), Askin's Tumor of the Chest Wall, Extraosseous Ewing's Sarcoma (EOE)
CountriesFrance, Italy, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartDec 2010
Primary CompletionApr 2012
TodayJul 2026
First PostedOct 18, 2010
Enrollment StartDec 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.7 years ago
Interventions
Zalypsisdrug
Zalypsis is provided as a lyophilized powder for concentrate for solution for infusion in a strength of 2.5 mg/vial.