Trial record 9 of 224 for:
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
This study has been completed.
Information provided by (Responsible Party):
First received: October 8, 2010
Last updated: June 4, 2012
Last verified: June 2012
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.
Primitive Neuroectodermal Tumor (PNET)
Askin's Tumor of the Chest Wall
Extraosseous Ewing's Sarcoma (EOE)
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Antitumor activity [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To determine the antitumor activity of Zalypsis® administered as a 1-hour intravenous (i.v.) infusion on Day 1, 8 and 15 every four weeks (d1, d8 and d15, q4wk) to patients with advanced and/or metastatic EFT.
Secondary Outcome Measures:
- To determine time-to-event efficacy parameters [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Safety profile and tolerability profile [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
To characterize the safety profile and tolerability of Zalypsis® in patients with unresectable advanced and/or metastatic EFT (Ewing Family of Tumors)
- Pharmacokinetics profile [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To characterize the pharmacokinetics (PK) of Zalypsis® when administered as a single-agent to patients with EFT
- Pharmacodynamic profile [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To determine the pharmacodynamic profile by measuring the effect of Zalypsis® on the number of Ewing's sarcoma circulating tumor cells (CTCs) at different times of treatment and its correlation with the clinical outcome.
- Pharmacogenomic (PGx) profile [ Time Frame: 36 months ] [ Designated as safety issue: No ]
To determine the pharmacogenomic (PGx) profile. Hypothesis-generating exploratory PGx analyses will be conducted to correlate the molecular parameters found in the tumor and blood samples of the patients with the clinical results achieved with Zalypsis®.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2012 (Final data collection date for primary outcome measure)
Experimental: Arm 1
Zalypsis is provided as a lyophilized powder for concentrate for solution for infusion in a strength of 2.5 mg/vial.
Other Name: PM00104
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is clearly documented or biopsy proven.
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/l; platelet count ≥ 100 x 109/l, and hemoglobin ≥ 9 g/dl.
- Adequate renal function: calculated creatinine clearance (using Cockcroft and Gault's formula) ≥ 30 ml/min.
Adequate hepatic function:
- Total bilirubin ≤ 1.5 x upper limit or normality (ULN), unless due to Gilbert's syndrome.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 x ULN (≤ 5 x ULN in case of hepatic metastases), and alkaline phosphatase (AP) ≤ 2.5 x ULN (≤ 5 x ULN in case of extensive bone involvement).
- Albumin ≥ 25 g/l.
- Left ventricular ejection fraction (LVEF) within normal limits (LVEF of at least 50%).
- Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment. Acceptable methods of contraception include complete abstinence, intrauterine device (IUD), oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository).
- 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.
- 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.
- Limitation of the patient's ability to comply with the treatment or to follow-up at a participating center. Patients enrolled into this trial must be treated and followed at a participating center.
- Treatment with any investigational product within 30 days prior to inclusion in the study.
- Known hypersensitivity to any component of Zalypsis®.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222767
|Sarcoma Oncology Center
|Santa Monica, California, United States, 90403 |
|St. Jude Children 's Research Hospital
|Memphis, Tennessee, United States, 38105A |
|Seattle Cancer Care Alliance
|Seattle, Washington, United States |
|Centre Léon Bérard
|Lyon, France, 69373 |
|Istituto Ortopedici Rizzoli
|Bologna, Italy, 40136 |
|Istituto Nazionale dei Tumori
|Milan, Italy, 20133 |
|Istituto Clinico Humanitas
|Rozzano, Italy, 20089 |
||Fariba Navid, MD
||St. Jude Children 's Research Hospital
||Sant P Chawla, MD
||Sarcoma Oncology Center
||Jean Yves Blay, MD
||Centre Léon Bérard
||Stefano Ferrari, MD
||Istituto Ortopedici Rizzoli
||Armando Santoro, Prof.
||Istituto Clinico Humanitas
||Paolo Casali, MD
||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
||Robin L. Jones, MD
||Seattle Cancer Care Alliance
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 8, 2010
||June 4, 2012
||United States: Food and Drug Administration
Keywords provided by PharmaMar:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2013
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue