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Clinical Trials/EUCTR2009-016879-29-GB
EUCTR2009-016879-29-GBActive, not recruitingPhase 1

GR015: Randomized double-blind phase III study of NGR-hTNF plus best investigator’s choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma (MPM) - NGR015

MOLMED0 sites400 target enrollmentStarted: October 26, 2010Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
400
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •1. Age = 18 years
  • •2. Histological or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown
  • •3. Prior treatment with no more than one systemic pemetrexed-based chemotherapy regimen administered for advanced or metastatic disease. Prior use of a biological agent in combination with a pemetrexed-based regimen and prior administration of intrapleural cytotoxic agents are allowed. Patients who have
  • •previously received anthracyclines should not receive doxorubicin.
  • •4. ECOG Performance Status 0 - 2 (Appendix A)
  • •5. Life expectancy of = 12 weeks
  • •6. 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
  • •7. Measurable or non-measurable disease according to MPM-modified RECIST criteria
  • •8. Patients may have had prior treatment providing the following conditions are met:
  • •a. Surgery: wash-out period of 14 days
  • •b. Systemic anti-tumor and radiation therapy: wash-out period of 28 days
  • •9. 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 390
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 390

Exclusion Criteria

  • •1. Patients must not receive any other investigational agents while on study
  • •2. 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
  • •3. Uncontrolled hypertension
  • •4. 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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