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Malignant Pleural MesotheliomaPhase 2NGR010NCT00484276

Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma

A Phase 2 study testing NGR-hTNF in people with Malignant Pleural Mesothelioma, run by AGC Biologics S.p.A. at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as single agent. Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Pleural Mesothelioma
What is being tested?
NGR-hTNF
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
4 sitesItaly
Study dates
May 2007to Mar 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients >18 years affected by malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen
  • Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatous, mixed
  • Prior intrapleural cytotoxic agents including bleomycin not considered systemic chemotherapy
  • 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
Show all 16Show fewer
  • 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 hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (take as reference "Technical data sheet human albumin" specifically used in Pharmacy Department for NGR-hTNF dilution)
  • Patients may have had prior therapy providing the following conditions are met:
  • Chemotherapy and radiotherapy: wash-out period of 28 days
  • Surgery: wash-out period of 14 days
  • Normal cardiac function and absence of uncontrolled hypertension
  • Patients must give written informed consent to participate in the study

Who cannot join

  • Concurrent anticancer therapy
  • Patients may not receive any other investigational agents while on study
  • 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 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. 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

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

  • Fondazione San Raffaele del Monte Tabor

    Milan

  • Istituto Europeo Oncologico

    Milan

  • Istituto Nazionale dei Tumori

    Milan

  • Istituto Clinico Humanitas

    Rozzano, Milan

Other trials in Italy

About this study

Official title: NGR010: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Malignant Pleural Mesothelioma Previously Treated With no More Than One Systemic Therapeutic Regimen

The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic malignant pleural mesothelioma patients treated with NGR-hTNF as single agent.

Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria.

Read the detailed description

This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic malignant pleural mesothelioma previously treated with no more than one systemic therapeutic regimen , that will be conducted using Simon's two-stage design method.

Being tested
NGR-hTNF
Keywords
NGR-hTNF, malignant pleural mesothelioma
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NGR-hTNFDrug

    iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Study groups in NCT00484276
Study groupRoleWhat they receive
NGR-hTNFExperimentalNGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every 3 weeks or weekly
Receives: Drug: NGR-hTNF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antitumor activity defined as progression free survival (PFS)

    Defined as the time from the date of randomization until disease progression, or death

    Measured: during the study

Secondary outcomes (6)

  1. Tumor Growth Control Rate (TGCR)

    Evaluated according to modified RECIST criteria for Malignant Pleural Mesothelioma

    Measured: Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD

  2. Overall survival (OS)

    Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive

    Measured: from the randomization until to the date of patient death or discontinuation from the study

  3. Experimental Imaging Study (DCE-MRI)

    To document possible modifications on vessels permeability by imaging techniques

    Measured: During the treatment

  4. Cmax of NGR-hTNF in patients treated with weekly schedule

    to evaluate Cmax of NGR-hTNF administered weekly

    Measured: During the treatment

  5. AUC(tau) of NGR-hTNF in patients treated with weekly schedule

    to evaluate AUC(tau) of NGR-hTNF administered weekly

    Measured: During the treatment

  6. Safety according to NCI-CTCAE criteria (version 3)

    To evaluate safety profile related to NGR-hTNF

    Measured: During the treatment and during the follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00484276
Sponsor's protocol ID
NGR010
Other IDs
2006-005993-39
Acronym
NGR010
Status last verified
Jan 2019
First submitted
7 Jun 2007
Last updated
16 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • Gregorc V, Zucali PA, Santoro A, Ceresoli GL, Citterio G, De Pas TM, Zilembo N, De Vincenzo F, Simonelli M, Rossoni G, Spreafico A, Grazia Vigano M, Fontana F, De Braud FG, Bajetta E, Caligaris-Cappio F, Bruzzi P, Lambiase A, Bordignon C. Phase II study of asparagine-glycine-arginine-human tumor necrosis factor alpha, a selective vascular targeting agent, in previously treated patients with malignant pleural mesothelioma. J Clin Oncol. 2010 May 20;28(15):2604-11. doi: 10.1200/JCO.2009.27.3649. Epub 2010 Apr 20.

    PubMed 20406925

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NGR-hTNF in people with Malignant Pleural Mesothelioma, run by AGC Biologics S.p.A. at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antitumor activity defined as progression free survival (PFS) (time frame: during the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00484276, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.

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