NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this extension protocol is to evaluate the early safety of a new schedule of NGR-hTNF given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm A, as compared to a reference cohort of 12 patients randomized to an anthracycline alone

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGC Biologics S.p.A.; MolMed S.p.A.
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage

• Patients previously treated with a maximum of two platinum-based regimen plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population)

• ECOG Performance status 0 - 2

• Life expectancy of 12 weeks or more

• Normal cardiac function and absence of uncontrolled hypertension

• Adequate baseline bone marrow, hepatic and renal function defined as follows:

1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL

2. Bilirubin ≤ 1.5 x ULN

3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis

4. Serum creatinine < 1.5 x ULN

• At least one (not previously irradiated) target lesion or non-measurable disease only, according to RECIST criteria

• Patients may have had prior therapy providing the following conditions are met:

1. Surgery and radiation therapy: wash-out period of 14 days

2. Systemic anti-tumor therapy: wash-out period of 21 days

• Patients must give written informed consent to participate in the study

Exclusion Criteria:

• Patients must not receive any other investigational agents while on study

• More than two previous chemotherapy lines and previous treatment with anthracycline

• 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

• Prolonged QTc interval (congenital or acquired) > 450 ms

• History or evidence upon physical examination of CNS disease unless adequately treated

• 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 or contraindications 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