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Clinical Trials/EUCTR2010-023613-61-GB
EUCTR2010-023613-61-GBActive, not recruitingPhase 1

GR018: Randomized phase II study of NGR-hTNF plus an anthracycline versus an anthracycline alone in platinum-resistant ovarian cancer - NGR018

MOLMED0 sites133 target enrollmentStarted: April 2, 2012Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
133
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • •1.Age = 18 years
  • •2.Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage
  • •3.Patients previously treated with a maximum of two platinum-based regimen (cisplatin or carboplatin) plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population)
  • •4.ECOG Performance status 0 - 2 (Appendix A)
  • •5.Life expectancy of 12 weeks or more
  • •6.Normal cardiac function (LVEF = 50%) and absence of uncontrolled hypertension
  • •7.Adequate baseline bone marrow, hepatic and renal function, defined as follows:
  • •a.Neutrophils = 1.5 x 109/L; platelets = 100 x 109/L; hemoglobin = 9 g/dL
  • •b.Bilirubin = 1.5 x ULN
  • •c.AST and/or ALT = 2.5 x ULN in absence of liver metastasis or = 5 x ULN in presence of liver metastasis
  • •d.Serum creatinine < 1.5 x ULN
  • •8.At least one (not previously irradiated) target lesion that could be measured in one dimension, or non-measurable disease only, according to RECIST criteria
  • •9.Patients may have had prior therapy providing the following conditions are met:
  • •a.Surgery and radiation therapy: wash-out period of 14 days
  • •b.Systemic anti-tumor therapy: wash-out period of 21 days
  • •10.Patients must give written informed consent to participate in the study
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1.Patients must not receive any other investigational agents while on study
  • •2.More than two previous chemotherapy lines and previous treatment with anthracycline
  • •3.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
  • •4.Prolonged QTc interval (congenital or acquired) > 450 ms
  • •5.History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy or history of stroke)
  • •6.Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
  • •7.Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
  • •8.Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
  • •9.Pregnancy or lactation.

Investigators

Sponsor
MOLMED

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