GR018: randomized study that schedules two treatments one with NGR-hTNF plus pegylated liposomal doxorubicin (PLD) and the other one with PLD in platinum-resistant ovarian cancer
- Conditions
- Advanced or metastatic platinum-resistant ovarian cancer patientsMedDRA version: 13.1Level: 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
- EUCTR2010-023613-61-IT
- Lead Sponsor
- MOLMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1. Age = 18 years 2. Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage 3. Patients previously treated with a maximum of two platinum-based regimen (cisplatin or carboplatin) plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population) 4. ECOG Performance status 0 - 2 (Appendix A) 5. Life expectancy of 12 weeks or more 6. Normal cardiac function (LVEF = 50%) and absence of uncontrolled hypertension 7.Adequate baseline bone marrow, hepatic and renal function, 8. At least one (not previously irradiated) target lesion that could be measured in one dimension, or non-measurable disease only, according to RECIST criteria 9. Patients may have had prior therapy providing the following conditions are met: a. Surgery and radiation therapy: wash-out period of 14 days b. Systemic anti-tumor therapy: wash-out period of 21 days 10. 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Patients must not receive any other investigational agents while on study 2. More than two previous chemotherapy lines 3. Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication 4. Prolonged QTc interval (congenital or acquired) > 450 ms 5. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy or history of stroke) 6. Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol 7. Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients 8. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol 9. Pregnancy or lactation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus PLD versus patients randomized to PLD;Secondary Objective: • To compare overall survival (OS) • To compare response rate (RR) • To compare disease control rate (DCR) • To compare duration of disease control • To evaluate safety/toxicity profile related to NGR-hTNF;Primary end point(s): To compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus PLD versus patients randomized to PLD;Timepoint(s) of evaluation of this end point: Approximately from 3 to 6 months <br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • To compare overall survival (OS) • To compare response rate (RR) • To compare disease control rate (DCR) • To compare duration of disease control • To evaluate safety/toxicity profile related to NGR-hTNF <br>;Timepoint(s) of evaluation of this end point: Approximately from 3 to 12 months <br>