Studie k posouzení bezpečnosti a snášenlivosti přípravku Camizestrant v kombinaci s atirmociclibem u žen s pokročilým karcinomem prsu (SERENA-1b)
Fáze IIa, otevřená studie hodnotící bezpečnost, farmakokinetiku a předběžnou účinnost přípravku Camizestrant v kombinaci s Atirmociclibem u účastníků s ER-pozitivním, HER2-negativním pokročilým karcinomem prsu (SERENA-1b)
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This is a Phase IIa, sequential assignment, non- randomized, open-label treatment study to determine the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of camizestrant in combination with atirmociclib.
The single-arm study includes:
- Screening period
- Atirmociclib single dose period
- Doublet intervention period
- Post-treatment follow-up period
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: AstraZeneca Clinical Study Information Center
- Telefonní číslo: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studijní místa
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Cambridge, Spojené království, CB2 0QQ
- Nábor
- Research Site
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London, Spojené království, EC1M6BQ
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- Research Site
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Manchester, Spojené království, M20 4GJ
- Nábor
- Research Site
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Missouri
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St Louis, Missouri, Spojené státy, 63108
- Nábor
- Research Site
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Rhode Island
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East Providence, Rhode Island, Spojené státy, 02915
- Nábor
- Research Site
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Tennessee
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Nashville, Tennessee, Spojené státy, 37203
- Nábor
- Research Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Main Inclusion Criteria:
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Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.
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Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.
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Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.
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At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.
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Menopausal status
- Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.
- Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age <60 years with ≥12 months amenorrhea and post-menopausal hormone levels.
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Histological or cytological confirmation of adenocarcinoma of the breast.
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Participants of childbearing potential must agree to use one highly effective contraceptive measure.
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Documentation of ER-positive tumor irrespective of progesterone receptor status.
Main Exclusion Criteria:
- A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting.
- A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.
- Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.
- Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.
- Inability to swallow oral medications.
- Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).
- Presence of life-threatening metastatic visceral disease.
- Any evidence of severe or uncontrolled systemic diseases.
- Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Camizestrant + Atirmociclib
Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1. |
Camizestrant will be administered orally. Atirmociclib will be administered orally. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of participants with adverse events (AEs) and serious AEs
Časové okno: Up to Post-Treatment Follow up (Day 30 Post Dose)
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To investigate the safety and tolerability of camizestrant in combination with atirmociclib. |
Up to Post-Treatment Follow up (Day 30 Post Dose)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Maximum concentration observed (Cmax)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Time to reach maximum (peak) plasma concentration following drug administration (tmax)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Terminal elimination rate constant (λz)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Terminal elimination half-life (t½λz)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Apparent total body clearance (CL/F)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Apparent volume of distribution at steady state (Vss/F)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Apparent volume of distribution based on the terminal phase (Vz/F)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
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Maximum concentration observed at steady state (Cssmax)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Area under the curve from 0 to the end of dosing interval (AUC0-tau)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Area under the curve from 0 to the end of dosing interval at steady state (AUCss0-tau)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Time to reach maximum plasma concentration at steady state (tssmax)
Časové okno: At pre-defined intervals from Day -1 to Day 57
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To characterise the PK profile and parameters of atirmociclib and camizestrant after administration in combination with each other. |
At pre-defined intervals from Day -1 to Day 57
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Objective Response Rate (ORR)
Časové okno: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Duration of Response (DOR)
Časové okno: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Clinical Benefit Rate at 24 Weeks (CBR24)
Časové okno: At 24 weeks
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 24 weeks
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Percentage change in tumor size
Časové okno: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Progression Free Survival (PFS)
Časové okno: Up to 2 years
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
Up to 2 years
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Progression-free survival landmark 6 months (PFSLM6m)
Časové okno: At 6 months
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 6 months
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Progression-free survival landmark 12 months (PFSLM12m)
Časové okno: At 12 months
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To assess the preliminary anti-tumor activity and efficacy of camizestrant in combination with atirmociclib. |
At 12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- D853CC00001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Časový rámec sdílení IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Kritéria přístupu pro sdílení IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
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