Badanie oceniające bezpieczeństwo i tolerancję kamizestrantu w skojarzeniu z atirmocyklibem u kobiet z zaawansowanym rakiem piersi (SERENA-1b)
Badanie fazy IIa, otwarte, mające na celu ocenę bezpieczeństwa, farmakokinetyki i wstępnej skuteczności kamizestrantu w skojarzeniu z atirmocyklibem u uczestników z zaawansowanym rakiem piersi ER-dodatnim, HER2-ujemnym (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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: AstraZeneca Clinical Study Information Center
- Numer telefonu: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Lokalizacje studiów
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Missouri
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St Louis, Missouri, Stany Zjednoczone, 63108
- Rekrutacyjny
- Research Site
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Rhode Island
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East Providence, Rhode Island, Stany Zjednoczone, 02915
- Rekrutacyjny
- Research Site
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37203
- Rekrutacyjny
- Research Site
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Cambridge, Zjednoczone Królestwo, CB2 0QQ
- Rekrutacyjny
- Research Site
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London, Zjednoczone Królestwo, EC1M6BQ
- Rekrutacyjny
- Research Site
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Manchester, Zjednoczone Królestwo, M20 4GJ
- Rekrutacyjny
- Research Site
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of participants with adverse events (AEs) and serious AEs
Ramy czasowe: Up to Post-Treatment Follow up (Day 30 Post Dose)
|
To investigate the safety and tolerability of camizestrant in combination with atirmociclib. |
Up to Post-Treatment Follow up (Day 30 Post Dose)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maximum concentration observed (Cmax)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Time to reach maximum (peak) plasma concentration following drug administration (tmax)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Terminal elimination rate constant (λz)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Terminal elimination half-life (t½λz)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Apparent total body clearance (CL/F)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Apparent volume of distribution at steady state (Vss/F)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Apparent volume of distribution based on the terminal phase (Vz/F)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
To characterize the PK profile and parameters of atirmociclib. |
At pre-defined intervals from Day -1 to Day 57
|
|
Maximum concentration observed at steady state (Cssmax)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
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)
Ramy czasowe: At pre-defined intervals from Day -1 to Day 57
|
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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Up to 2 years
|
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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- D853CC00001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania 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.
Kryteria dostępu do udostępniania 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 informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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