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NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer

Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate
constitutional symptoms, the reversibility of these adverse events generally occurring only
during the infusion time; the absence of overlapping toxicities with chemotherapeutic
agents; the safety and preliminary antitumor activity observed in previous trial with
doxorubicin; and the objective response rate (RR) registered in a phase II trial in
previously treated ovarian cancer patients seems justified to evaluate in a randomized phase
II trial the efficacy of NGR-hTNF against a doxorubicin-based option in advanced ovarian
cancer patients progressing or recurrent after a standard platinum/taxane-based

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

- Good clinical Conditions

- Normal cardiac function

- Adequate baseline bone marrow, hepatic and renal function

- 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

Exclusion Criteria:

- Patients may 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Defined as the time from the date of randomization until disease progression, or death

Outcome Time Frame:

every 6-8-12 weeks

Safety Issue:


Principal Investigator

Antonio Lambiase, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.


Italy: Ethics Committee

Study ID:




Start Date:

June 2011

Completion Date:

February 2014

Related Keywords:

  • Ovarian Cancer
  • NGR-hTNF
  • Pegylated liposomal doxorubicin
  • Doxorubicin
  • Platinum-resistant
  • Progression or recurrence Ovarian Cancer
  • Ovarian Cancer
  • Advanced or metastatic
  • Ovarian Neoplasms