- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02591095
A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer (MONAVI-1)
15. mars 2019 oppdatert av: Centre Francois Baclesse
ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
47
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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Besançon, Frankrike
- CHU Besançon - Hôpital Jean Minjoz
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Bordeaux, Frankrike
- Institut Bergonie
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Caen, Frankrike
- Centre Francois Baclesse
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Lille, Frankrike
- Centre Oscar Lambret
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Lyon, Frankrike
- CHU
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Lyon, Frankrike
- Centre Léon Bérard
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Montpellier, Frankrike
- ICM Val d'Aurelle
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Nancy, Frankrike
- ICL Institut de Cancérologie de Lorraine
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Nantes, Frankrike
- Centre Catherine de Sienne
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Nantes, Frankrike
- ICO Centre Rene Gauducheau
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Nantes, Frankrike
- ICO Paul Papin
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Nice, Frankrike
- Centre Antoine Lacassagne
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Paris, Frankrike
- Hôpital Européen Georges Pompidou
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Paris, Frankrike
- Hôpital Tenon
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Toulouse, Frankrike
- Institut Claudius Regaud
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Villejuif, Frankrike
- Gustave Roussy
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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
Hunn
Beskrivelse
Inclusion Criteria:
- - Woman older than 18 years
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Histologically and/or cytologically documented high grade serous epithelial cancer of ovarian, fallopian tube or peritoneum
- Platinum resistant ovarian cancer defined as relapsing within 6 months after a platinum based chemotherapy OR platinum refractory ovarian cancer defined as progressing during a platinum based chemotherapy (excepted refractory patients in first line)
- Subjects having received at least 2 prior lines of treatments including platinum regimen
- Subjects who are willing and able to comply with the protocol and study procedures including willingness to undergo tumor biopsy before therapy at screening
- There is no limitation to prior number of therapies
- Patients must have documented disease progression
- Subjects who have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:• Absolute Neutrophil Count ≥ 1500/ mm3
- Platelets ≥ 150,000 / mm3
- Hemoglobin ≥ 9.0 g/dL
- Renal function: Serum creatinine ≤1.2mg/dL or calculated creatinine clearance ≥ 60mL/min
- AST/ALT ≤ 3.0× the upper limit of normal (ULN); [Subjects with liver metastasis may have AST, ALP, and ALT less then or equal to 5.0 X ULN]
- Bilirubin ≤ 1.25×ULN
- Coagulation: aPTT and PT not to exceed 1.2 × ULN
- LVEF > 50% by echocardiograms or MUGA
- Patients must give written informed consent
Exclusion Criteria:
- Patient's refusal or impossibility to perform biopsy on relapsing disease
- Bowel occlusive syndrome or other gastro-intestinal disorder that does not allow oral medication such as malabsorption
- Patients with platinum refractory disease in first line
- Received radio-immunotherapy within 6 months of 1st dose of study drug
- Received steroid therapy for anti-neoplastic intent within 7 days of the 1st dose of study drug (Inhaled steroids for asthma, topical steroids, replacement/stress corticosteroids, or corticosteroids taken as premedication are allowed)
- Consumption of grapefruit or grapefruit products within 3 days prior to the first dose of study drug
- Patient receiving treatments strong CYP3A4 inhibitors or inducers (Appendix A)
- Positive for HIV and VHC
- Predisposing condition/currently exhibiting signs of bleeding
- Currently receiving anticoagulation therapy, exception of low-dose anticoagulation medications for prophylaxis
- Received aspirin within 7 days of start dose of study drug
- Active peptic ulcer disease / other potentially hemorrhagic esophagitis/gastritis
- Active immune thrombocytopenic purpura, autoimmune hemolytic anemia or history of being refractory to platelet transfusions (within 1 year of 1st dose of study drug)
- Uncontrolled cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease, active systemic fungal infection; diagnosis of fever and neutropenia within 1 week of study drug administration
- A evidence of current/active malignancies other than ovarian cancer
- Pregnant or lactating women
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: ABT-263
oral Navitoclax (ABT-263) daily
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The primary endpoint is the progression-free survival (PFS) in the whole cohort of patients with a recurrent platinum-resistant ovarian cancer.
Tidsramme: the time to progression (or death from any cause) from date of randomization until date of first documented progression or date of death from any cause,whichever came first, assessed up to 12 months. Evaluation at interim and final analyses.
|
the time to progression (or death from any cause) from date of randomization until date of first documented progression or date of death from any cause,whichever came first, assessed up to 12 months. Evaluation at interim and final analyses.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Bim expression level
Tidsramme: biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
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Bim expression level expressed by immunohistochemistry on biopsy of relapsing tumor at inclusion
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biopsy sample before initiation of treatment by ABT-263 and assessment within 6 months after end of inclusions
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Response rate
Tidsramme: evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
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- Response rate defined by a complete response (CR), a partial response (PR) or a stable disease (SD) according to the RECIST v1.1
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evaluated every 6 weeks during treatment to progression or death for any cause.(during average 12 months)]
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Overall survival (OS)
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
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Incidence of Treatment-Emergent Adverse Events according to the NCI CTC AE version 4.0
Tidsramme: From date of treatment start until end of study participation (during average 12 months)]
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Toxicities
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From date of treatment start until end of study participation (during average 12 months)]
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Peak Plasma Concentration of ABT-263
Tidsramme: 8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions
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8-hour post-dose PK on D1 of C1 & 2. Dosage will be done within 12 months after end of inclusions
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Residual concentration of ABT-263
Tidsramme: Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions
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Pre-dose 0 and cycles 3, 4, 6 . Dosage will be done within 12 months after end of inclusions
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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. januar 2016
Primær fullføring (Faktiske)
1. april 2017
Studiet fullført (Faktiske)
1. mars 2019
Datoer for studieregistrering
Først innsendt
14. oktober 2015
Først innsendt som oppfylte QC-kriteriene
28. oktober 2015
Først lagt ut (Anslag)
29. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Karsinom
- Neoplasmer, kjertel og epitel
- Genitale neoplasmer, kvinnelige
- Sykdommer i det endokrine systemet
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Gonadal lidelser
- Neoplasmer i endokrine kjertel
- Neoplasmer i eggstokkene
- Karsinom, ovarieepitel
- Antineoplastiske midler
- Navitoclax
Andre studie-ID-numre
- 2015-000193-35
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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