Étude de l'AZD5305 en monothérapie et en association avec des agents anticancéreux chez des patients atteints de tumeurs malignes solides avancées (PETRA)
Une étude modulaire de phase I/IIa, ouverte et multicentrique pour évaluer l'innocuité, la tolérance, la pharmacocinétique, la pharmacodynamique et l'efficacité préliminaire de doses croissantes d'AZD5305 en monothérapie et en association avec des agents anticancéreux chez des patients atteints de tumeurs malignes solides avancées
This research is designed to determine if experimental treatment with PARP inhibitor, AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
Aperçu de l'étude
Statut
Les conditions
- Cancer du col de l'utérus
- Cancer du sein
- Cancer de l'estomac
- Cancer colorectal
- Cancer du pancréas
- Cancer des ovaires
- Cancer de la prostate
- Cancer de la vessie
- Cancer de l'endomètre
- Cancer du poumon non à petites cellules
- Cancer biliaire
- Indications supplémentaires ci-dessous pour les modules 4 et 5
- Cancer du poumon à petites cellules uniquement dans le module 5
Description détaillée
This study is a Phase I/IIa modular, open-label, multi-center study of AZD5305 administered orally, either as monotherapy or in combination with other anti-cancer agents in patients with advanced solid malignancies.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Heidelberg, Australie, 3084
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Melbourne, Australie, 3000
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1K1
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Montreal, Quebec, Canada, H2X 0A9
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Beijing, Chine, 100142
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Changchun, Chine, 130021
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Changsha, Chine, 410013
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Chengdu, Chine, 610041
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Chongqing, Chine, 400030
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Guangzhou, Chine, 510060
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Harbin, Chine, 150081
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Jining, Chine, 272029
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Shandong, Chine
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Shanghai, Chine, 200032
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Shanghai, Chine, 200025
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Taiyuan, Chine, 030001
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Wuhan, Chine, 430079
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Xi'an, Chine, 710061
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Seoul, Corée du Sud, 03080
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Seoul, Corée du Sud, 03722
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Seoul, Corée du Sud, 05505
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Seoul, Corée du Sud, 06351
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Barcelona, Espagne, 08035
- Research Site
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Madrid, Espagne, 28041
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Madrid, Espagne, 28040
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Madrid, Espagne, 28050
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Málaga, Espagne, 29010
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Pozuelo de Alarcón, Espagne, 28223
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Seville, Espagne, 41013
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Budapest, Hongrie, 1122
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Budapest, Hongrie, 1062
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Budapest, Hongrie, 1082
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Milan, Italie, 20141
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Milan, Italie, 20132
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Modena, Italie, 41125
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Naples, Italie, 80131
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Padova, Italie, 35128
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Roma, Italie, 00168
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Chūōku, Japon, 104-0045
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Kōtoku, Japon, 135-8550
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Bydgoszcz, Pologne, 85-796
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Gdansk, Pologne, 80-214
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Gdynia, Pologne, 81-519
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Grzepnica, Pologne, 72-003
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Lodz, Pologne, 90-302
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Torun, Pologne, 87-100
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Warsaw, Pologne, 02-781
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Cambridge, Royaume-Uni, CB2 0QQ
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Manchester, Royaume-Uni, M20 4BX
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Oxford, Royaume-Uni, OX3 7LE
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Sutton, Royaume-Uni, SM2 5PT
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Moscow, Russie, 115478
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Moscow, Russie, 117997
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Moscow, Russie, 111123
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Moscow, Russie, 143442
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Brno, Tchéquie, 656 53
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Prague, Tchéquie, 15006
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Chernivtsі, Ukraine, 58013
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Ivano-Frankivsk, Ukraine, 76018
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Kyiv, Ukraine, 03022
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Uzhhorod, Ukraine, 88000
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
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Boston, Massachusetts, États-Unis, 02215
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New York
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New York, New York, États-Unis, 10021
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
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Texas
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Houston, Texas, États-Unis, 77030
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Key Inclusion Criteria:
- Age ≥ 18 at the time of screening
- Histological or cytological confirmation of advanced malignancy considered to be suitable for study treatment and meeting module specific eligibility criteria..
- Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
- Life expectancy ≥ 12 weeks
- Progressive cancer at the time of study entry
- Patients must have evaluable disease as defined in module-specific criteria for Part A and Part B
- Adequate organ and marrow function as defined by the protocol.
- For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded (FFPE) tumour specimen is mandatory, where available, except if stated that it is optional in a specific Module.
For Part A:
- Patients may have received up to one prior line of therapy with a PARPi-based regimen (either as a treatment or as maintenance)
For Part B:
- Patients must not have received prior therapy with a PARPi-based regimen (either as a treatment or as maintenance).
Key Exclusion Criteria:
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Treatment with any of the following:
- Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
- Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 3 weeks (whichever is shorter) of the first dose of study treatment
- Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
- Any live virus or bacterial vaccine within 28 days of the first dose of study treatment
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Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong inhibitors or inducers.
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Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.
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Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.
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Major surgery within 4 weeks of the first dose of study treatment.
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Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
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Any history of persisting (> 2 weeks) severe pancytopenia due to any cause
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Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. Patients with leptomeningeal carcinomatosis are excluded.
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patient with known predisposition to bleeding (e.g., active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
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Cardiac conditions as defined by the clinical study protocol
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Other cardiovascular diseases as defined by any of the following:
- Symptomatic heart failure,
- uncontrolled hypertension,
- hypertensive heart disease with significant left ventricular hypertrophy
- acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.
- cardiomyopathy of any etiology
- presence of clinically significant valvular heart disease
- history of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation and optimally controlled ventricular rate (< 100 beats per minute) are permitted.
- subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
- transient ischaemic attack, or stroke within 6 months prior to screening
- patients with symptomatic hypotension at screening
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Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
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Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305
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Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
Prior malignancy whose natural history, in the Investigator's opinion, has the potential to interfere with safety and efficacy assessments of the investigational regimen.
other module-specific criteria may apply
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Module 1: AZD5305 Monotherapy
AZD5305 Monotherapy |
Oral PARP inhibitor |
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Expérimental: Module 2: AZD5305 + Paclitaxel
AZD5305 + Paclitaxel |
Oral PARP inhibitor IV Anti-microtubule agent |
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Expérimental: Module 3: AZD5305 + Carboplatin with or without Paclitaxel
AZD5305 + Carboplatin with or without Paclitaxel |
Oral PARP inhibitor IV Anti-microtubule agent IV Platinum chemotherapeutic |
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Expérimental: Module 4: AZD5305 + Trastuzumab Deruxtecan
AZD5305 + T- DXd |
Oral PARP inhibitor IV Antibody-drug conjugate |
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Expérimental: Module 5 AZD5305 + Datopotamab Deruxtecan
AZD5305 + Dato-DXd |
Oral PARP inhibitor IV Antibody-drug conjugate |
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Expérimental: Module 6 AZD5305 + Camizestrant
AZD5305 + Camizestrant |
Oral PARP inhibitor Oral SERD Molecule |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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The number of subjects with adverse events/serious adverse events
Délai: From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4.
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Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline |
From time of Informed Consent to 28 + 7 days post last dose ( modules 1,2,3,5 and 6). 40+7 days post last dose for Module 4.
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The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
Délai: From first dose of study treatment until the end of Cycle 1.
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A DLT is defined as any toxicity that occurs from the first dose of study treatment (either AZD5305 or combination anti-cancer agent) up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation. DLTs occurring outside the DLT window (ie, late onset toxicities) may be defined as a DLT after consultation with the sponsor and investigators, based on the emerging safety profile. |
From first dose of study treatment until the end of Cycle 1.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Best percentage change in target lesion
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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Change in target lesion size from baseline, as defined by RECIST 1.1. |
From Screening to confirmed progressive disease (approximately 1 year)
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Objective Response Rate
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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Best response until progression, as defined by RECIST 1.1. |
From Screening to confirmed progressive disease (approximately 1 year)
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Duration of Response
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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Time from first response to progression or death , as defined by RECIST 1.1. |
From Screening to confirmed progressive disease (approximately 1 year)
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Progression Free Survival
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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Time from C1D1 to progression or death, as defined by RECIST 1.1. |
From Screening to confirmed progressive disease (approximately 1 year)
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Time To Response
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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Time from C1D1 to complete or partial response, as defined by RECIST 1.1. |
From Screening to confirmed progressive disease (approximately 1 year)
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Effects of AZD5305 on pH2AX (Ser139) PD biomarker
Délai: From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)
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Measure change from baseline in pH2AX |
From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)
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CA125 response (ovarian cancer)
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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at least a 50% reduction in CA125 levels from a pre-treatment sample as defined by GCIG criteria. |
From Screening to confirmed progressive disease (approximately 1 year)
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Module 1: Area Under Curve (AUC)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 1: Maximum plasma concentration of the drug (Cmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Cmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 1: The time taken to reach the maximum concentration (Tmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Tmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 1 and Module 5: Objective Response Rate (prostate cancer)
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone) |
From Screening to confirmed progressive disease (approximately 1 year)
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Module 1: Radiographic progression free survival (prostate cancer)
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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Time from C1D1 to progression or death, as defined by RECIST 1.1 and PCWG3(bone). |
From Screening to confirmed progressive disease (approximately 1 year)
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Module 1: Proportion of subjects with ≥ 50% PSA decrease (prostate cancer)
Délai: From Screening to confirmed progressive disease (approximately 1 year)
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PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment |
From Screening to confirmed progressive disease (approximately 1 year)
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Module 1 : To investigate the effect of a high-fat meal on the PK of AZD5305
Délai: Cycle 0, Day 1 (C0D1), in either the "fasted" or "fed" state, followed by a single oral dose of AZD5305 in the other state for Cycle 1, Day 1 (C1D1) at least 72 hours later; 1 cycle is 28 days.
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Effect on High fat meal on PK parameters of AZD5305.PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without food |
Cycle 0, Day 1 (C0D1), in either the "fasted" or "fed" state, followed by a single oral dose of AZD5305 in the other state for Cycle 1, Day 1 (C1D1) at least 72 hours later; 1 cycle is 28 days.
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Module 2: Area Under Curve (AUC)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 2: Maximum plasma concentration of the drug (Cmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Cmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 2: The time taken to reach the maximum concentration (Tmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Tmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 3: Area Under Curve (AUC)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 3: Maximum plasma concentration of the drug (Cmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Cmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 3: The time taken to reach the maximum concentration (Tmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Tmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 4 : Area Under Curve
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 4: Maximum plasma concentration of the drug (Cmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Cmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 4: The time taken to reach the maximum concentration (Tmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Tmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 4: Anti-Drug Antibody (ADA)
Délai: Samples will be collected within 1 hour before dose administration on Day 1 of Cycle 1, 2, and 4, then every 4 Cycles (each cycle is 21 days), EoT, and at safety follow-up (40 days after last dose) as per Schedule of Assessments
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To investigate the presence of ADAs for T-DXd |
Samples will be collected within 1 hour before dose administration on Day 1 of Cycle 1, 2, and 4, then every 4 Cycles (each cycle is 21 days), EoT, and at safety follow-up (40 days after last dose) as per Schedule of Assessments
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Module 4: To assess the preliminary anti-tumour activity of AZD5305 as monotherapy and in combination with T-DXd.
Délai: From screening to approximately 6 months
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Time from C1D1 to progression or death, as defined by RECIST v 1.1 summarised at the 6 month landmark (PFS6) |
From screening to approximately 6 months
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Module 5: Area Under Curve
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 5: Maximum plasma concentration of the drug (Cmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Cmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 5: The time taken to reach the maximum concentration (Tmax)
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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The concentration of AZD5305 in plasma will be determined (Tmax will be derived). |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 5: Anti-Drug Antibody (ADA)
Délai: Whole blood samples for determination of ADA for Dato-DXd in plasma will be collected in patients receiving Dato-DXd per the schedule specified in the SoA : Day 1 of Cycle 1, 2, 4, and 8 (each cycle is 21 days) , EoT, and then 28 day follow up visit.
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Presence of ADAs for Dato-DXd |
Whole blood samples for determination of ADA for Dato-DXd in plasma will be collected in patients receiving Dato-DXd per the schedule specified in the SoA : Day 1 of Cycle 1, 2, 4, and 8 (each cycle is 21 days) , EoT, and then 28 day follow up visit.
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Module 5: Premilinary anti tumour activity AZD5305 in combination with Dato-DXd
Délai: From screening to confirmed progresive disease ( approximately 12 weeks)
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objective response rate and radiographic progression-free survival using RECIST v1.1. Proportion of patients achieving a ≥ 50% decrease in PSA from baseline to the post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later (PSA50 response). |
From screening to confirmed progresive disease ( approximately 12 weeks)
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Module 6: To characterise the PK of AZD5305 and camizestrant following a single dose and at steady state after multiple dosing, when given in combination.
Délai: At predefined interval throughout the treatment (approximately 12 weeks)
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Plasma concentrations and PK parameters of AZD5305 and camizestrant after single dose and multiple dose administration, including, but not limited to: AUC, Cmax, Tmax, as data allow |
At predefined interval throughout the treatment (approximately 12 weeks)
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Module 6: To evaluate the effect of camizestrant on the PK of AZD5305.
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without camizestrant. |
At predefined intervals throughout the treatment period (approximately 12 weeks)
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Module 6: To evaluate the effect of AZD5305 on the PK of Camizestrant.
Délai: At predefined intervals throughout the treatment period (approximately 12 weeks)
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PK parameters, including but not limited to AUC and/or AUC(0-t), Cmax, Tmax, AUC(0-t) and Cmax ratio, with and without AZD5305. |
At predefined intervals throughout the treatment period (approximately 12 weeks)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Timothy Yap, M.D. Anderson Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Maladies du système endocrinien
- Tumeurs génitales, homme
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies intestinales
- Maladies des voies respiratoires
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs intestinales
- Maladies rectales
- Maladies utérines
- Maladies génitales, femme
- Maladies pulmonaires
- Tumeurs des glandes endocrines
- Maladies pancréatiques
- Maladies des voies biliaires
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Maladies du côlon
- Tumeurs pulmonaires
- Maladies ovariennes
- Maladies annexielles
- Tumeurs génitales, femme
- Troubles gonadiques
- Maladies de la peau
- Maladies du sein
- Tumeurs urologiques
- Maladies du col de l'utérus
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs utérines
- Maladies de la vessie urinaire
- Maladies de la peau et du tissu conjonctif
- Tumeurs prostatiques
- Tumeurs de l'estomac
- Tumeurs des voies biliaires
- Tumeurs colorectales
- Tumeurs ovariennes
- Tumeurs mammaires
- Tumeurs pancréatiques
- Carcinome pulmonaire non à petites cellules
- Tumeurs du col de l'utérus
- Tumeurs de la vessie urinaire
- Tumeurs de l'endomètre
- Produits chimiques organiques
- Hydrocarbures
- Cycloparaffines
- Hydrocarbures, alicyclique
- Hydrocarbures, cyclique
- Terpènes
- Complexes de coordination
- Taxes
- Cyclodécanes
- Diterpènes
- Carboplatine
- Paclitaxel
- AZD5305
- AZD9833
Autres numéros d'identification d'étude
- D9720C00001
- 2020-002688-77 (Numéro EudraCT)
Informations sur les médicaments et les dispositifs, documents d'étude
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