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NGR012: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Advanced or Metastatic Ovarian Cancer

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Trial Information

NGR012: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Ovarian Cancer

This is a phase II, open-label,single arm, non-randomized study that will be conducted in
patients affected by metastatic ovarian cancer, that will be conducted using Simon's
two-stage design method.

Inclusion Criteria:

- Patients ≥18 years old affected by advanced or metastatic ovarian cancer previously
treated with platinum regimens (cis or carboplatin) plus paclitaxel and with
documented progression disease within 6 months from last chemotherapy administered
(refractory/resistant population) or in progression disease after 6 months from last
chemotherapy (platinum regimens plus paclitaxel) administered

- Rechallenge with platinum regimens

- No previous exposure to anthracyclines

- Histologically or cytologically confirmed ovarian carcinoma

- Life expectancy more than 3 months

- ECOG Performance status 0 - 1

- Normal cardiac function (LVEF ≥55%) and absence of uncontrolled hypertension

- Measurable disease defined as ≥1 unidimensional measurable lesion ≥ 20 mm by
conventional technics or ≥ 10 mm ( spiral CT scan or PET); ascites is allowed if
present with peritoneal carcinosis

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

- Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L

- Bilirubin < 1.5 x ULN

- AST and/or ALT < 2.5 x ULN in absence of liver metastasis

- AST and/or ALT < 5 x ULN in presence of liver metastasis

- Serum creatinine < 1.5 x ULN

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

- Chemotherapy and radiotherapy: wash-out period of 28 days

- Surgery: wash-out period of 14 days

- Absence of any conditions in which hypervolaemia and its consequences (e.g. increased
stroke volume, elevated blood pressure) or haemodilution could represent a risk for
the patient (take as reference "Technical data sheet human albumin" specifically used
in Pharmacy Department for NGR-hTNF dilution)

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

Exclusion criteria:

- Concurrent anticancer therapy

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

- New York Heart Association class II-IV cardiac disease

- Acute angina

- Patients with myocardial infarction within the last six (6) months

- Patient with significant peripheral vascular disease

- Thrombosis of main portal vein

- Clinical signs of CNS involvement

- 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. Patients with reproductive potential (i.e. menopausal for
less than 1-year and not surgically sterilized) must practice effective contraceptive
measures throughout the study. Women of childbearing potential must provide a
negative pregnancy test (serum or urine) within 14 days prior to registration.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity defined as response rate according to RECIST criteria

Outcome Time Frame:

during the study

Safety Issue:


Principal Investigator

Antonio Lambiase, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.


Italy: Ethics Committee

Study ID:




Start Date:

November 2008

Completion Date:

September 2013

Related Keywords:

  • Advanced or Metastatic Ovarian Cancer
  • NGR-hTNF
  • Ovarian cancer
  • Doxorubicin
  • Ovarian Neoplasms