Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewi… (NCT01222767) | Clinical Trial Compass
CompletedPhase 2
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
United States, France, Italy17 participantsStarted 2010-12
Plain-language 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.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Voluntary written informed consent, obtained from the patient or his/her representative before the beginning of any specific study procedures.
✓. Age ≥ 16 years.
✓. Histologically or cytologically confirmed EFT (Ewing Family of Tumors), with recurrent disease.
✓. Documented failure to at least one prior chemotherapy regimen for their disease.
✓. Radiographic documentation of disease progression at study entry.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≤ 2.
✓. Life expectancy ≥ 3 months.
✓. 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.
Exclusion criteria
✕. Prior therapy with Zalypsis®.
✕. Pregnant or lactating women or women of childbearing potential not using an appropriate contraceptive method.
✕. Less than three weeks from prior radiation therapy, biological therapy or chemotherapy.
✕. 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.
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: At baseline and every other cycle (± 1 week) until evidence of PD, up to 2 years
✕. Patients with a prior invasive malignancy (except non-melanoma 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.
✕. Evidence of progressive or symptomatic central nervous system (CNS) metastases or leptomeningeal metastases.
✕. Other diseases or serious conditions:
✕. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in the study. The Investigator should feel free to consult the Study Coordinator or the Sponsor(s) in case of uncertainty in this regard.