Phase II exploratory study of brostallicin PNU-166196A in patients with ovarian cancer resistant/refractory to platinum based chemotherapy. - ND

• Conditions: Advanced/metastatic ovarian cancer resistant or refractory to platinum.; MedDRA version: 6.1Level: PTClassification code 10033128

• Registration Number: EUCTR2005-005646-39-IT
• Lead Sponsor: ERVIANO MEDICAL SCIENCES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

1.Histologically or cytologically proven diagnosis of advanced/metastatic epithelian ovarian cancer 2.Progressive disease after at least one prior platinum based regimen 3.Age / 18 4.Eastern Cooperative Oncology Group ECOG performance status PS of 0 or 1 5.Life expectancy of / 3 months at study entry i.e. from informed consent signature date 6.At least one measurable lesion according to RECIST criteria 7.All acute toxic effects excluding alopecia of any prior therapy must have resolved to CTCAE Version 3.0 Grade / 1 8.Required initial laboratory data to be eligible for study entry are Absolute neutrophil count ANC / 1,500/mm3 / Grade 1 , Platelets PLT / 100,000/mm3, Hemoglobin / 10.0 g/dL / Grade 1 , Total serum bilirubin / 1.5 x ULN / Grade 1 , Liver transaminases AST/ALT / 2.5 x ULN; / Grade 1 ; in case of liver metastasis / 5 x ULN , Alkaline Phosphatase ALP / 2.5 x ULN / Grade 1 ; in case of liver metastasis / 5 x ULN , Serum Albumin / 3.0 g/dL / Grade 1 , Serum creatinine / 1.25 x ULN / 133 mcmol/L and/or creatinine clearance / 60 mL/min 9.Wash out period of at least 4 weeks from surgery, from radiotherapy or from previous chemotherapy 10.Negative serum pregnancy test for females of childbearing potential / 7 days before starting treatment 11.Signed written informed consent prior to beginning protocol specific procedures 12.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients who received more than 2 prior chemotherapy lines of treatment for advanced/metastatic ovarian cancer 2.Second malignancies. Patients with prior history of other malignancies must have been disease free for / 5 years. Previous histories of basal cell carcinoma of the skin or in situ carcinoma of the cervix are accepted 3.Patients with clinically significant cardiac disease or myocardial infarction within the last 6 months before study entry 4.Known brain or leptomeningeal disease CT-scan or MRI of the brain required only in case of clinical suspicion of central nervous system metastases 5.Active uncontrolled infection including known positive human immunodeficiency virus HIV 6.Pregnancy or breast-feeding. Patients must agree to avoid becoming pregnant during the study and in the following 3 months after the end of the treatment, be surgically sterile or be postmenopausal. 7.Irradiation to / 25 of her bone marrow 8.Concomitant treatment with any other anti-cancer therapy and/or investigational agent 9.Patients who have participated in any investigational drug study within 4 weeks preceding treatment start 10.Medical or psychological condition that would not permit the patient to complete the trial or understand and sign informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified