- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00484341
Phase II Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Soft Tissue Sarcomas.
27. august 2018 oppdatert av: AGC Biologics S.p.A.
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Faktiske)
69
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Lyon, Frankrike, 69373
- Centre Léon Bérard
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Villejuif, Frankrike, 94805
- Institut de Cancerologie Gustave Roussy
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Bologna, Italia, 40136
- Istituto Ortopedico Rizzoli
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Milan, Italia, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
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Pavia, Italia, 27100
- IRCCS Policlinico S. Matteo
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Rome, Italia, 00128
- Università Campus Bio-Medico
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Wirral
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Bebington, Wirral, Storbritannia, BA11 3
- Clatterbridge Centre for Oncology
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: A: low-dose NGR-hTNF
0.8 mcg/m² of NGR-hTNF
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NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
Andre navn:
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Eksperimentell: B: high-dose NGR-hTNF
45 mcg/m² of NGR-hTNF
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NGR-hTNF: 45 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
Andre navn:
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Eksperimentell: C: low-dose NGR-hTNF + doxorubicin
0.8 mcg/m² of NGR-hTNF + doxorubicin
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NGR-hTNF: 0.8 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
Andre navn:
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
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Eksperimentell: D: high-dose NGR-hTNF + doxorubicin
45 mcg/m² of NGR-hTNF + doxorubicin
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NGR-hTNF: 45 mcg/m² as 60-minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
Andre navn:
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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Progression-Free Survival (PFS)
Tidsramme: every 6-12 weeks
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Defined as the time from the date of randomization until disease progression, or death
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every 6-12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Total overlevelse (OS)
Tidsramme: hver 6-12 uke
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Definert som tiden fra randomiseringsdatoen til dødsdatoen på grunn av en hvilken som helst årsak eller siste dato pasienten var kjent for å være i live
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hver 6-12 uke
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Safety and Toxicity according to NCI-CTCAE criteria (version 4.02)
Tidsramme: during the study
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To evaluate safety and toxicity profile related to NGR-hTNF
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during the study
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Duration of Disease Control
Tidsramme: every 6-12 weeks
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Measured from the date of randomization until disease progression, or death due to any cause
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every 6-12 weeks
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Response rate
Tidsramme: every 6-12 weeks
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Measured both according to RECIST criteria and by FDG-PET
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every 6-12 weeks
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Tumor response
Tidsramme: every 6-12 weeks
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Evaluated by a centralized review of changes in tumor density on CT scan and/or perfusion MRI
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every 6-12 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2010
Primær fullføring (Faktiske)
1. mai 2016
Studiet fullført (Faktiske)
1. mai 2016
Datoer for studieregistrering
Først innsendt
7. juni 2007
Først innsendt som oppfylte QC-kriteriene
7. juni 2007
Først lagt ut (Anslag)
8. juni 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NGR016
- 2010-018851-88 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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