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)
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
69
3 countries
7
Study Start
October 2010
Actual (reported)Primary Completion
May 2016
Actual (reported)Study Completion
May 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 7, 2007
Actual (reported)June 8, 2007
Actual (reported)October 2010
Actual (reported)May 2016
Actual (reported)May 2016
Actual (reported)Progression-Free Survival (PFS)
Defined as the time from the date of randomization until disease progression, or death
every 6-12 weeks
Safety and Toxicity according to NCI-CTCAE criteria (version 4.02)
during the study
Duration of Disease Control
every 6-12 weeks
Overall survival (OS)
every 6-12 weeks
Response rate
every 6-12 weeks
Tumor response
every 6-12 weeks
0.8 mcg/m² of NGR-hTNF
45 mcg/m² of NGR-hTNF
0.8 mcg/m² of NGR-hTNF + doxorubicin
NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
Centre Leon Berard
Lyon, 69373, France
Institut de Cancérologie Gustave Roussy
Villejuif, 94805, France
Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, 20133, Italy
IRCCS Policlinico S. Matteo
Pavia, 27100, Italy
Università Campus Bio-Medico
Rome, 00128, Italy
Clatterbridge Centre for Oncology
Bebington, Wirral, BA11 3, United Kingdom
Antonio Lambiase, MD
AGC Biologics S.p.A.
69 participants (actual enrollment reported by the registry).
First Submitted
June 7, 2007
First Posted
June 8, 2007
Study Start
October 2010
Actual (reported)Primary Completion
45 mcg/m² of NGR-hTNF + doxorubicin
NGR-hTNF: 45 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
May 2016
Actual (reported)Study Completion
May 2016
Actual (reported)Last Updated
August 29, 2018
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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