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Solid TumorsPhase 1NCT00483093

Study of NGR-hTNF in Combination With Cisplatin in Solid Tumor

A Phase 1 study testing NGR-hTNF and Cisplatin in people with Solid Tumors, run by AGC Biologics S.p.A. at 2 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 safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
NGR-hTNF and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesItaly
Study dates
Jul 2007to Apr 2013
Phase
Phase 1
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 with advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and suitable for a treatment with cisplatin
  • Life expectancy more than 3 months
  • ECOG Performance status 0-1
  • Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) may represent a risk for the patient
  • 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
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  • 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
  • Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50 ml/min
  • 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
  • Corticosteroid therapy wash out period of 14 days
  • Surgery: wash-out period of 14 days
  • Patients must give written informed consent to participate in the study

Who cannot join

  • Previous signs of severe toxicity platinum related
  • Patients must not receive any other investigational agents while on study
  • New York Heart Association class III or IV cardiac disease
  • Unstable angina
  • Patients with myocardial infarction within the last six (6) months
  • Patient with significant peripheral vascular disease
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  • 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

2 sites in 1 country.

Italy2 sites

  • Fondazione San Raffaele del Monte Tabor

    Milan, Milan,

  • Istituto Europeo Oncologico

    Milan, Milan

Other trials in Italy

About this study

Official title: NGR004:A Phase IB Study of NGR-hTNF in Combination With Cisplatin in Patient Affected by Advanced or Metastatic Solid Tumor

The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).

Read the detailed description

This is a phase IB, open-label, non-randomized, dose-escalation study that will be conducted in sequential cohorts of patients. Three patients per each cohort are planned.

Patients, with advanced or metastatic solid tumor not amenable of standard therapy will be enrolled.

Conditions
Solid Tumors
Being tested
NGR-hTNF, Cisplatin
Keywords
NGR-hTNF, cisplatin, solid tumors

What participants receive

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

  • NGR-hTNFDrug

    iv q3W escalating dose NGR-hTNF up to 1.6 mcg/sqm

  • CisplatinDrug

    iv q3W 80 mg/sqm 30 minutes after NGR-hTNF infusion for a maximum of six cycles

Study groups in NCT00483093
Study groupRoleWhat they receive
AExperimentalNot described
Receives: Drug: NGR-hTNF; Drug: Cisplatin

What is being measured

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

  1. To verify the safety of escalating doses of NGRhTNF (from 0.2 to 1.6 µg/m^2) in combination with cisplatin (80 mg/m^2) every 3 weeks

    Measured: To recommend a dose regimen of NGR-hTNF + Cisplatin for future phase II trials

Secondary outcomes (3)

  1. To document the preliminary antitumor activity of the combination in terms of objective response rate according to RECIST criteria

    Measured: every six weeks

  2. To evaluate the pharmacokinetic profiles of the combination of NGR-hTNF and cisplatin

    Measured: During the study

  3. To measure plasma levels of sTNFRs and anti-NGR-hTNF antibodies

    Measured: During the study

Timeline

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

  1. First posted6 Jun 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJun 2010
  4. Study completionApr 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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00483093
Sponsor's protocol ID
NGR004
Other IDs
2006-006035-42
Status last verified
May 2014
First submitted
5 Jun 2007
Last updated
30 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Gregorc V, De Braud FG, De Pas TM, Scalamogna R, Citterio G, Milani A, Boselli S, Catania C, Donadoni G, Rossoni G, Ghio D, Spitaleri G, Ammannati C, Colombi S, Caligaris-Cappio F, Lambiase A, Bordignon C. Phase I study of NGR-hTNF, a selective vascular targeting agent, in combination with cisplatin in refractory solid tumors. Clin Cancer Res. 2011 Apr 1;17(7):1964-72. doi: 10.1158/1078-0432.CCR-10-1376. Epub 2011 Feb 9.

    PubMed 21307147

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NGR-hTNF and Cisplatin in people with Solid Tumors, run by AGC Biologics S.p.A. at 2 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 11 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 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

To verify the safety of escalating doses of NGRhTNF (from 0.2 to 1.6 µg/m^2) in combination with cisplatin (80 mg/m^2) every 3 weeks (time frame: To recommend a dose regimen of NGR-hTNF + Cisplatin for future phase II trials). 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 NCT00483093, 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 30 May 2014.

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