Status:
COMPLETED
NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)
Lead Sponsor:
AGC Biologics S.p.A.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
In this extension protocol IPR/26 of completed IPR/24 study, considering the relatively short half-life of approximately 1 hour and the favourable toxicity profile of NGR-hTNF, characterized by transi...
Eligibility Criteria
Inclusion
- 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:
- Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 1.5 x ULN
- AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis
- 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:
- Surgery and radiation therapy: wash-out period of 14 days
- Systemic anti-tumor therapy: wash-out period of 21 days
- Patients must give written informed consent to participate in the study
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03804866
Start Date
March 1 2013
End Date
December 1 2016
Last Update
January 15 2019
Active Locations (4)
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1
Ospedale San Raffaele
Milan, Italy, 20132
2
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
3
Istituto Europeo di Oncologia
Milan, Italy, 20141
4
Istituto Nazionale Tumori IRCCS Fondazione "Giovanni Pascale"
Naples, Italy, 80131