GR012: A phase II study of NGR-hTNF administered in combination with doxorubicin every 3 weeks in patients affected by advanced or metastatic ovarian cancer - NGR012

Phase 1

• Conditions: Patients affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel; MedDRA version: 14.1Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-000004-33-IT
• Lead Sponsor: MOLMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-10
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

?Patients >=18 years old affected by advanced or metastatic ovarian cancer previously treated with platinum regimens (cis or carboplatin) plus paclitaxel and with documented progression disease within 6 months from last chemotherapy administered (refractory/resistant population) or in progression disease after 6 months from last chemotherapy (platinum regimens plus paclitaxel) administered ? Rechallenge with platinum regimens ? No previous exposure to anthracyclines ? Histologically or cytologically confirmed ovarian carcinoma ? Life expectancy more than 3 months ? ECOG Performance status 0 - 1 ? Normal cardiac function (LVEF >=55%) and absence of uncontrolled hypertension ? Measurable disease defined as >=1 unidimentionally measurable lesion >= 20 mm by conventional technics or >= 10 mm ( spiral CT scan or PET); ascites is allowed if present with peritoneal carcinosis ?Adequate baseline bone marrow, hepatic and renal function, defined as follows: neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L; bilirubin < 1.5 x ULN;AST and/or ALT < 2.5 x ULN in absence of liver metastasis;AST and/or ALT < 5 x ULN in presence of liver metastasis;Serum creatinine < 1.5 x ULN ? Absence of any conditions in which hypervolaemia and its consequences or haemodilution could represent a risk for the patient ? Patients must give written informed consent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

? Concurrent anticancer therapy ? Patients must not receive any other investigational agents while on study ? New York Heart Association class II-IV cardiac disease ? Acute angina ? Patients with myocardial infarction within the last six (6) months ? Patient with significant peripheral vascular disease ? Thrombosis of main portal vein ? Clinical signs of CNS involvement ? Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol ? Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients ? Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol ? Pregnancy or lactation.

Study & Design

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