Phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis®(PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic EwingFamily of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy.Étude de phase II , multicentrique, ouverte, clinique et pharmacocinétique de Zalypsis® (PM00104) chez des patients atteints d’un sarcome de la famille des tumeurs d’Ewing (EFT) non resécable, localement avancé et/ou métastatique en progression après au moins une première ligne chimiothérapique

Pharma Mar S.A., Sociedad Unipersonal0 sites29 target enrollmentOctober 11, 2010

Overview

No summary available.

Registry

who.int

Start Date

October 11, 2010

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pharma Mar S.A., Sociedad Unipersonal

•1\. Voluntary written informed consent, obtained from the patient or his/her representative before the beginning of any specific study procedures.
•2\. Age \= 16 years.
•3\. Histologically or cytologically confirmed EFT, with recurrent disease.
•4\. Documented failure to at least one prior chemotherapy regimen for their disease.
•5\. Radiographic documentation of disease progression at study entry.
•6\. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score \= 2\.
•7\. Life expectancy \= 3 months.
•8\. Complete recovery from the effects of drug\-related adverse events (AEs) derived from previous treatments, excluding alopecia and grade 1 peripheral neuropathy, according to the National Cancer Institute Common Terminology Criteria for
•Adverse Events (NCI\-CTCAE) v. 4\.0\.
•9\. At least one measurable lesion (target lesion” according to the RECIST v.1\.1\), located in a non\-irradiated area and adequately measured less than four weeks before study entry.

•1\. Prior therapy with Zalypsis®.
•2\. Pregnant or lactating women or women of childbearing potential not using an appropriate contraceptive method.
•3\. Less than three weeks from prior radiation therapy, biological therapy or chemotherapy.
•4\. Less than six weeks from prior nitrosourea, mitomycin C, high\-dose chemotherapy or radiotherapy involving the whole pelvis or over 50% of the spine, provided that acute effects of radiation treatment have resolved. Hormonal therapy and
•palliative radiation therapy (i.e., for control of pain from bone metastases) must be discontinued before study entry.
•5\. Patients with a prior invasive malignancy (except nonmelanoma skin cancer and in situ cervix carcinoma) who have had any evidence of disease within the last five years or whose prior malignancy treatment contraindicates the current protocol therapy.
•6\. Evidence of progressive or symptomatic central nervous system (CNS) metastases or leptomeningeal metastases.
•7\. Other diseases or serious conditions:
•a) Increased cardiac risk, as defined by:
•\-Unstable angina or myocardial infarction within 12 months before inclusion in the study.