Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer (NGR018)

A

AGC Biologics

Status and phase

Completed
Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Pegylated liposomal doxorubicin
Drug: Doxorubicin
Drug: NGR-hTNF

Study type

Interventional

Funder types

Industry

Identifiers

NCT01358071
2010-023613-61 (EudraCT Number)
NGR018

Details and patient eligibility

About

The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone

Full description

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 chemotherapy.

Enrollment

119 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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 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 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.

Trial design

119 participants in 2 patient groups

Arm A: NGR-hTNF+ anthracycline
Experimental group
Description:
NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin
Treatment:
Drug: NGR-hTNF
Drug: Doxorubicin
Drug: Pegylated liposomal doxorubicin
Arm B: anthracycline
Active Comparator group
Description:
Pegylated Liposomal Doxorubicin or Doxorubicin
Treatment:
Drug: Doxorubicin
Drug: Pegylated liposomal doxorubicin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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