Trials / Completed
CompletedNCT01222767
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
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- PharmaMar · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Zalypsis | Zalypsis is provided as a lyophilized powder for concentrate for solution for infusion in a strength of 2.5 mg/vial. |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2012-04-01
- Completion
- 2012-04-01
- First posted
- 2010-10-18
- Last updated
- 2021-10-29
- Results posted
- 2021-10-29
Locations
7 sites across 3 countries: United States, France, Italy
Source: ClinicalTrials.gov record NCT01222767. Inclusion in this directory is not an endorsement.