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Metastatic Adult Soft Tissue SarcomaPhase 2NCT00484341

Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas.

A Phase 2 study testing low-dose NGR-hTNF, high-dose NGR-hTNF and Doxorubicin in people with Metastatic Adult Soft Tissue Sarcoma, run by AGC Biologics S.p.A. at 7 sites in 3 countries.

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 preliminary antitumor activity of two doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally advanced or metastatic soft-tissue sarcoma (STS) patients untreated or previously treated with one or more prior systemic regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Adult Soft Tissue Sarcoma
What is being tested?
low-dose NGR-hTNF, high-dose NGR-hTNF and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
7 sitesin 3 countries
Study dates
Oct 2010to May 2016
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
  • Histologically-proven, locally advanced, or metastatic STS (excluding extraosseus Ewing sarcoma)
  • Patients not amenable to surgery, radiotherapy, or combined-modality therapy with curative intent
  • Patients untreated or previously treated with one or more systemic regimen
  • ECOG Performance status 0-2 (Appendix A)
  • At least one untreated (not previously irradiated) target lesion that could be measured in one dimension, according to RECIST criteria
Show all 17Show fewer
  • A life expectancy of 12 weeks or more
  • Adequate baseline bone marrow, hepatic and renal function, defined as follows:
  • Neutrophils > 1.5 x 109/L and platelets > 100 x 109/L
  • Bilirubin < 1.5 x ULN
  • AST and/or ALT < 2.5 x ULN in absence of liver metastasis or < 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 treatment providing the following conditions are met before treatment start:
  • Surgery and radiation therapy: wash-out period of 14 days
  • Systemic therapy: wash-out period of 21 days
  • Patients must give written informed consent

Who cannot join

  • 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
  • LVEF < 55% (only for patients candidate for doxorubicin treatment)
  • Uncontrolled hypertension
  • Prolonged QTc interval (congenital or acquired) > 450 ms
  • 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
Show all 10Show fewer
  • 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
  • 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 child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

Italy4 sites

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    Milan, 20133

  • IRCCS Policlinico S. Matteo

    Pavia, 27100

  • Università Campus Bio-Medico

    Rome, 00128

Other trials in Italy

France2 sites

  • Centre Leon Berard

    Lyon, 69373

  • Institut de Cancérologie Gustave Roussy

    Villejuif, 94805

Other trials in France

United Kingdom1 site

  • Clatterbridge Centre for Oncology

    Bebington, Wirral, BA11 3

Other trials in United Kingdom

About this study

Official title: NGR016: Randomized Phase II Study Evaluating Two Doses of NGR-hTNF Administered Either as Single Agent or in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma (STS)

The main objective of the trial is to document the preliminary antitumor activity of two doses of NGR-hTNF administered either alone or in combination with doxorubicin in locally advanced or metastatic soft-tissue sarcoma (STS) patients untreated or previously treated with one or more prior systemic regimen.

Read the detailed description

Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms when given either every three weeks or weekly both at low (0.8 µg/m^2) and high dose (45 µg/m^2); the reversibility of these adverse events generally occurring only during the infusion time; the absence of overlapping toxicities with chemotherapeutic agents; and the safety and preliminary antitumor activity observed in phase Ib trial with doxorubicin, seems justified to evaluate in a randomized 4-arm phase II trial the preliminary antitumor activity of two doses of NGR-hTNF (0.8 µg/m^2 and 45 µg/m^2) administered weekly either alone or in combination with a standard dose of doxorubicin (60 mg/m^2 every three weeks).

Being tested
low-dose NGR-hTNF, high-dose NGR-hTNF, Doxorubicin
Keywords
NGR-hTNF, Doxorubicin, Soft Tissue Sarcoma
Medical subject headings
Sarcoma

What participants receive

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

  • low-dose NGR-hTNFDrug

    Also called NGR-hTNF

    NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs

  • high-dose NGR-hTNFDrug

    Also called NGR-hTNF

    NGR-hTNF: 45 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs

  • DoxorubicinDrug

    Doxorubicin: 60 mg/m² intravenous infusion over 15 minutes (starting 1 hour after the end of NGR-hTNF infusion) on day 1 every 3 weeks for a maximum of 6 cycles or until cumulative dose of 550 mg/m²

Study groups in NCT00484341
Study groupRoleWhat they receive
A: low-dose NGR-hTNFExperimental0.8 mcg/m² of NGR-hTNF
Receives: Drug: low-dose NGR-hTNF
B: high-dose NGR-hTNFExperimental45 mcg/m² of NGR-hTNF
Receives: Drug: high-dose NGR-hTNF
C: low-dose NGR-hTNF + doxorubicinExperimental0.8 mcg/m² of NGR-hTNF + doxorubicin
Receives: Drug: low-dose NGR-hTNF; Drug: Doxorubicin
D: high-dose NGR-hTNF + doxorubicinExperimental45 mcg/m² of NGR-hTNF + doxorubicin
Receives: Drug: high-dose NGR-hTNF; Drug: Doxorubicin

What is being measured

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

  1. Progression-Free Survival (PFS)

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

    Measured: every 6-12 weeks

Secondary outcomes (5)

  1. Safety and Toxicity according to NCI-CTCAE criteria (version 4.02)

    To evaluate safety and toxicity profile related to NGR-hTNF

    Measured: during the study

  2. Duration of Disease Control

    Measured from the date of randomization until disease progression, or death due to any cause

    Measured: every 6-12 weeks

  3. 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: every 6-12 weeks

  4. Response rate

    Measured both according to RECIST criteria and by FDG-PET

    Measured: every 6-12 weeks

  5. Tumor response

    Evaluated by a centralized review of changes in tumor density on CT scan and/or perfusion MRI

    Measured: every 6-12 weeks

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 startOct 2010
  3. Primary completionMay 2016
  4. Study completionMay 2016

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00484341
Sponsor's protocol ID
NGR016
Other IDs
2010-018851-88
Status last verified
Aug 2018
First submitted
7 Jun 2007
Last updated
29 Aug 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing low-dose NGR-hTNF, high-dose NGR-hTNF and Doxorubicin in people with Metastatic Adult Soft Tissue Sarcoma, run by AGC Biologics S.p.A. at 7 sites in 3 countries.

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 17 inclusion and 10 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy, France, United Kingdom. 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?

Progression-Free Survival (PFS) (time frame: every 6-12 weeks). 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 NCT00484341.

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 29 Aug 2018.

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