Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy
10. januar 2019 oppdatert av: Ipsen
A Phase II, International, Multicenter, Open-label, Proof of Concept Study of BN83495 in Postmenopausal Women With Advanced, Metastatic or Recurrent Oestrogen Receptor (ER) Positive Endometrial Carcinoma Who Have Received One Line of Chemotherapy in the Adjuvant or Metastatic Setting.
The purpose of the protocol is to determine the effect of BN83495 on the progression of endometrial cancer with estrogen receptor in post menopausal women who had previously received chemotherapy.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
6
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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Ontario
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London, Ontario, Canada, N6A 4L6
- London Health Sciences Centre, University of Western Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Department of Oncology, Ottawa Cancer Center
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Toronto, Ontario, Canada, M5G 2M9
- Dept of Obstetrics and Gynecology, Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- CHUM-Hospital Notre-Dame Service de Gynecologic Oncologique
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Montreal, Quebec, Canada, H2W 1S6
- Department of Oncology, McGill University
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Georgia
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Augusta, Georgia, Forente stater, 30912
- Dept of Obstetrics and Gynecology, Medical College of Georgia
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- Division of Gynecologic Oncology, University of Minnesota Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104-4283
- Jordan Center for Gynecologic Cancer at Penn, University of Pennsylvania
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Upland, Pennsylvania, Forente stater, 19103
- Crozer Chester Medical Center
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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:
- Provision of written informed consent prior to any study related procedures.
- postmenopausal or ovariectomised female patient over 18 years of age.
- histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
- patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
- patient has at least one measurable disease site (RECIST criteria version 1.1)
Exclusion Criteria:
- patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
- patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
- patient was treated with any other investigational agent within the 3 weeks before study entry.
- patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.
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 |
|---|---|
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Eksperimentell: BN83495
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1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Determination of Clinical Benefit (CB), Defined as Sum of Patients Who Present Complete Response (CR), Partial Response (PR) or Stable Disease (SD) ≥12 Weeks (CB=CR+PR+SD≥12 Weeks) Using Response Evaluation Criteria in Solid Tumors (RECIST Version1.1)
Tidsramme: 12 weeks
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CR defined as: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR defined as: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD defined as: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum diameters while on study. PD defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
12 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Adverse Events
Tidsramme: Up to 28 days after last dose
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Up to 28 days after last dose
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Determination of Time to Progression (TTP) in This Patient Population
Tidsramme: After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Time to Progression (TTP): Time from first study treatment to first documentation of objective tumour progression.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Progression Free Survival (PFS) in This Patient Population
Tidsramme: After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Progression Free Survival (PFS): Time from first study treatment until objective tumour progression or death from any cause.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Overall Response Rate (ORR) in This Patient Population
Tidsramme: After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Overall Response Rate (ORR): Defined as the sum of CR and PR.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Duration of Response in This Patient Population
Tidsramme: After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Duration of Response (DR): Time from the first documentation of objective tumour response (defined as CR or PR) to the first documentation of objective tumour progression or death on study due to any cause.
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After the last enrolled patient has been followed for at least 6 months or has progressed or died
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Determination of Overall Survival in This Patient Population
Tidsramme: 2 years after the last patient enrolled
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Overall Survival (OS): Defined as the time from first study treatment to death due to any cause.
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2 years after the last patient enrolled
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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
1. november 2010
Primær fullføring (Faktiske)
1. juni 2011
Studiet fullført (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først innsendt
23. november 2010
Først innsendt som oppfylte QC-kriteriene
30. november 2010
Først lagt ut (Anslag)
1. desember 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. januar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. januar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- X-52-58064-007
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