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

September 12, 2019 updated by: AGC Biologics S.p.A.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 least one therapeutic regimen, that will be conducted using Simon's two-stage design method.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • Istituto nazionale Per la Ricerca sul Cancro
      • Genoa, Italy, 16132
        • Azienda Ospedaliera Universitaria San Martino
      • Milan, Italy, 20132
        • Fondazione San Raffaele del Monte Tabor
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Istituto Clinico Humanitas
    • Turin
      • Orbassano, Turin, Italy, 10043
        • Azienda Ospedaliera Universitaria San Luigi Gonzaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antitumour Activity Defined as Progression Free Survival (PFS)
Time Frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 150 weeks
Defined as the time from the date of randomization until disease progression, or death due to any cause or the last patient was known to be alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (Recist v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition the appearance of one or more new lesions was also considered progression
From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 150 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Growth Control Rate (TGCR)
Time Frame: Assessed every 6-12 weeks, up to 150 weeks

evaluated according to Response evaluation criteria in solid tumors (RECIST V1.0) for target lesions and assessed by MRI:

  • Complete Response (CR):Disappearance of all target lesions
  • Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the base line sum LD
  • Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Assessed every 6-12 weeks, up to 150 weeks
Overall Survival (OS)
Time Frame: Through study completion, an average of 3 years
Overall Survival was defined as the time from the baseline CT scan to death due to any cause, or the last date the patient was known to be alive.
Through study completion, an average of 3 years
Experimental Imaging Study (DCE-MRI)
Time Frame: during the study
To document possible modifications on vessels permeability by imaging techniques
during the study
Number of Adverse Events, Reported by Severity and Relation to Treatment
Time Frame: Through study completion, an average of 3 years
Evaluation according to NCI common terminology criteria for adverse events (version 3.0)
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGC Biologics S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2007

Primary Completion (Actual)

September 22, 2010

Study Completion (Actual)

May 17, 2011

Study Registration Dates

First Submitted

June 6, 2007

First Submitted That Met QC Criteria

June 6, 2007

First Posted (Estimate)

June 7, 2007

Study Record Updates

Last Update Posted (Actual)

October 4, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGR007
  • 2006-005700-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Cell Lung Cancer

Clinical Trials on NGR-hTNF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe