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Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma (NGR007)

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ClinicalTrials.gov Identifier: NCT00483509
Recruitment Status : Unknown
Verified October 2015 by MolMed S.p.A..
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2007
Last Update Posted : October 9, 2015
Information provided by (Responsible Party):
MolMed S.p.A.

Brief Summary:
The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic SCLC patients affected by advanced or metastatic small cell lung carcinoma (SCLC) previously treated with at least one therapeutic regimen

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: NGR-hTNF Drug: Doxorubicin Phase 2

Detailed Description:
This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at the least one therapeutic regimen, that will be conducted using Simon's two-stage design method.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NGR007: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Small Cell Lung Carcinoma (SCLC) Previously Treated With at Least One Therapeutic Regimen
Study Start Date : December 2006
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A: NGR-hTNF + doxorubicin
NGR-hTNF plus doxorubicin
Drug: NGR-hTNF
iv q3W 0.8 mcg/sqm NGR-hTNF
Drug: Doxorubicin
iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion

Primary Outcome Measures :
  1. Antitumour activity defined as progression free survival (PFS) [ Time Frame: during the trial ]

Secondary Outcome Measures :
  1. Tumor Growth Control Rate (TGCR) [ Time Frame: during the trial ]
  2. Overall survival (OS) [ Time Frame: during the treatment and during the follow-up ]
  3. Experimental Imaging Study (DCE-MRI) [ Time Frame: during the study ]
  4. Safety [ Time Frame: During the treatment and during the follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ≥ 18 years affected by SCLC previously treated with at least one therapeutic regimen (including doxorubicin). However, in case of patient already pretreated with doxorubicin, a previous cumulative dose of doxorubicin < 300 mg/m^2 is recommended and the current treatment has to be stopped when a maximum cumulative dose of doxorubicin 550 mg/m^2 is reached.
  • Cytology or histology confirmed SCLC at first diagnosis (patient with recurrent disease do not require a confirmatory biopsy to be eligible)
  • Measurable disease, defined as ≥ 1 unidimensional measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by CT scan according to RECIST criteria
  • ECOG Performance status 0 - 2
  • 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
  • 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 (reference appendix "Technical data sheet human albumin")
  • Normal cardiac function (LVEF ≥ 55%) and absence of uncontrolled hypertension
  • Patients may have had prior therapy providing the following conditions are met:

    - Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days before start treatment

    - Surgery: wash-out period of 14 days before start treatment

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

Exclusion Criteria:

  • Concurrent anticancer therapy
  • Patients may not receive any other investigational agents while on study
  • Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  • Uncontrolled hypertension
  • Prolonged QTc interval (congenital or acquired)
  • Patient with significant peripheral vascular disease
  • Previous signs of cardiotoxicity doxorubicin related
  • 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 or contraindications to human albumin preparations or to any of the excipients
  • Known hypersensitivity/allergic reaction or contraindications to anthracyclines
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
  • Pregnancy or lactation. Patients - both males and females - 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483509

Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Turin, Italy, 10043
Azienda Ospedaliera Universitaria San Martino
Genoa, Italy, 16132
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Fondazione San Raffaele del Monte Tabor
Milan, Italy, 20132
Sponsors and Collaborators
MolMed S.p.A.
Study Director: Antonio Lambiase, MD MolMed S.p.A.

Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00483509     History of Changes
Other Study ID Numbers: NGR007
2006-005700-14 ( EudraCT Number )
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015

Keywords provided by MolMed S.p.A.:

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action