NCT01222767

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

Completed Phase 2 Results posted Last updated 30 September 2021

What this trial tests

Phase 2 trial testing Zalypsis in Ewing's Sarcoma in 17 participants. Completed in 1 April 2012.

Timeline

1 December 2010

Primary endpoint
1 April 2012

1 April 2012

Quick facts

Lead sponsor	PharmaMar
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	1 December 2010
Primary completion	1 April 2012
Estimated completion	1 April 2012
Sites	7 locations across United States, France, Italy

Drugs / interventions tested

• Zalypsis — full drug profile →

Conditions studied

• Ewing's Sarcoma — all drugs for Ewing's Sarcoma →
• Primitive Neuroectodermal Tumor (PNET) — all drugs for Primitive Neuroectodermal Tumor (PNET) →
• Askin's Tumor of the Chest Wall — all drugs for Askin's Tumor of the Chest Wall →
• Extraosseous Ewing's Sarcoma (EOE) — all drugs for Extraosseous Ewing's Sarcoma (EOE) →

Sponsor

PharmaMar — full company profile →

Who can join

16 and older, any sex, with Ewing's Sarcoma or Primitive Neuroectodermal Tumor (PNET). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall Response Rate (ORR)
  Time frame: At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years
  Overall response rate (ORR), defined as the percentage of patients with confirmed objective response (OR), either CR or PR according to the RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Marine-Derived Anticancer Agents Targeting Apoptotic Pathways: Exploring the Depths for Novel Cancer Therapies.
   Dalisay DS, Tenebro CP, Sabido EM, Suarez AFL, et al · · 2024 · cited 14× · PMID 38535455 · DOI 10.3390/md22030114
2. Systematic review of phase-I/II trials enrolling refractory and recurrent Ewing sarcoma: Actual knowledge and future directions to optimize the research.
   Felix A, Berlanga P, Toulmonde M, Landman-Parker J, et al · · 2021 · cited 14× · PMID 33452711 · DOI 10.1002/cam4.3712
3. Heterogeneous Circulating Tumor Cells in Sarcoma: Implication for Clinical Practice.
   Agnoletto C, Caruso C, Garofalo C. · · 2021 · cited 12× · PMID 34063272 · DOI 10.3390/cancers13092189
4. Levels of active tyrosine kinase receptor determine the tumor response to Zalypsis.
   Moneo V, Serelde BG, Blanco-Aparicio C, Diaz-Uriarte R, et al · · 2014 · cited 8× · PMID 24758355 · DOI 10.1186/1471-2407-14-281
5. Multiple Myeloma: Possible Cure from the Sea.
   Capalbo A, Lauritano C. · · 2022 · cited 5× · PMID 35740630 · DOI 10.3390/cancers14122965