Advanced or metastatic platinum-resistant ovarian cancer patients
Conditions
Interventions
Product Name: NGR-hTNF
Product Code: MM102
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: MM102
Other descriptive name: NGR-hTN
Sponsors
MolMed S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 nonmeasurable 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 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 1. Patients must not receive any other investigational agents while on study 2. More than two previous chemotherapy lines and previous treatment with anthracycline 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To document the preliminary efficacy in terms of progression-free and overall survival, response rate, disease control rate, and duration of disease control in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone;Timepoint(s) of evaluation of this end point: From 3 to 12 months | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the early safety of NGR-hTNF given every week (instead of every 3 or 4 weeks such as in IPR/24 study) plus an anthracycline in 12 patients randomized to experimental arm A, as compared to 12 patients randomized to control arm B and treated with an anthracycline alone;Secondary Objective: To document the preliminary efficacy in terms of progression-free and overall survival, response rate, disease control rate, and duration of disease control in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone;Primary end point(s): To determine the early safety of NGR-hTNF given every week (instead of every 3 or 4 weeks such as in IPR/24 study) plus an anthracycline in 12 patients randomized to experimental arm A, as compared to 12 patients randomized to control arm B and treated with an anthracycline alone;Timepoint(s) of evaluation of this end point: Weekly | — |
Countries
Italy
Contacts
Public ContactClinical Development
MolMed S.p.A.
Outcome results
None listed