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Studie van AZD5305 als monotherapie en in combinatie met antikankermiddelen bij patiënten met gevorderde solide maligniteiten (PETRA)

18 september 2026 bijgewerkt door: AstraZeneca

Een modulaire fase I/IIa, open-label, multicentrische studie om de veiligheid, verdraagbaarheid, farmacokinetiek, farmacodynamiek en voorlopige werkzaamheid te beoordelen van oplopende doses AZD5305 als monotherapie en in combinatie met antikankermiddelen bij patiënten met vergevorderde solide maligniteiten

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

702

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
      • Heidelberg, Australië, 3084
        • Research Site
      • Melbourne, Australië, 3000
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1K1
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Research Site
  • China
      • Beijing, China, 100142
        • Research Site
      • Changchun, China, 130021
        • Research Site
      • Changsha, China, 410013
        • Research Site
      • Chengdu, China, 610041
        • Research Site
      • Chongqing, China, 400030
        • Research Site
      • Guangzhou, China, 510060
        • Research Site
      • Harbin, China, 150081
        • Research Site
      • Jining, China, 272029
        • Research Site
      • Shandong, China
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shanghai, China, 200025
        • Research Site
      • Taiyuan, China, 030001
        • Research Site
      • Wuhan, China, 430079
        • Research Site
      • Xi'an, China, 710061
        • Research Site
  • Hongarije
      • Budapest, Hongarije, 1122
        • Research Site
      • Budapest, Hongarije, 1062
        • Research Site
      • Budapest, Hongarije, 1082
        • Research Site
  • Italië
      • Milan, Italië, 20141
        • Research Site
      • Milan, Italië, 20132
        • Research Site
      • Modena, Italië, 41125
        • Research Site
      • Naples, Italië, 80131
        • Research Site
      • Padova, Italië, 35128
        • Research Site
      • Roma, Italië, 00168
        • Research Site
  • Japan
      • Chūōku, Japan, 104-0045
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Research Site
  • Oekraïne
      • Chernivtsі, Oekraïne, 58013
        • Research Site
      • Ivano-Frankivsk, Oekraïne, 76018
        • Research Site
      • Kyiv, Oekraïne, 03022
        • Research Site
      • Uzhhorod, Oekraïne, 88000
        • Research Site
  • Polen
      • Bydgoszcz, Polen, 85-796
        • Research Site
      • Gdansk, Polen, 80-214
        • Research Site
      • Gdynia, Polen, 81-519
        • Research Site
      • Grzepnica, Polen, 72-003
        • Research Site
      • Lodz, Polen, 90-302
        • Research Site
      • Torun, Polen, 87-100
        • Research Site
      • Warsaw, Polen, 02-781
        • Research Site
  • Rusland
      • Moscow, Rusland, 115478
        • Research Site
      • Moscow, Rusland, 117997
        • Research Site
      • Moscow, Rusland, 111123
        • Research Site
      • Moscow, Rusland, 143442
        • Research Site
  • Spanje
      • Barcelona, Spanje, 08035
        • Research Site
      • Madrid, Spanje, 28041
        • Research Site
      • Madrid, Spanje, 28040
        • Research Site
      • Madrid, Spanje, 28050
        • Research Site
      • Málaga, Spanje, 29010
        • Research Site
      • Pozuelo de Alarcón, Spanje, 28223
        • Research Site
      • Seville, Spanje, 41013
        • Research Site
  • Tsjechië
      • Brno, Tsjechië, 656 53
        • Research Site
      • Prague, Tsjechië, 15006
        • Research Site
  • Verenigd Koninkrijk
      • Cambridge, Verenigd Koninkrijk, CB2 0QQ
        • Research Site
      • Manchester, Verenigd Koninkrijk, M20 4BX
        • Research Site
      • Oxford, Verenigd Koninkrijk, OX3 7LE
        • Research Site
      • Sutton, Verenigd Koninkrijk, SM2 5PT
        • Research Site
  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Research Site
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Research Site
    • New York
      • New York, New York, Verenigde Staten, 10021
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • Research Site
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • Research Site
  • Zuid -Korea
      • Seoul, Zuid -Korea, 03080
        • Research Site
      • Seoul, Zuid -Korea, 03722
        • Research Site
      • Seoul, Zuid -Korea, 05505
        • Research Site
      • Seoul, Zuid -Korea, 06351
        • Research Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 130 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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:

  • Treatment with any of the following:

    1. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
    2. 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
    3. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment
    4. Any live virus or bacterial vaccine within 28 days of the first dose of study treatment

  • Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4 (CYP3A4) strong inhibitors or inducers.

  • Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of Torsades de Pointes.

  • Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or equivalent for any reason.

  • Major surgery within 4 weeks of the first dose of study treatment.

  • 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.

  • Any history of persisting (> 2 weeks) severe pancytopenia due to any cause

  • 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.

  • patient with known predisposition to bleeding (e.g., active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).

  • Cardiac conditions as defined by the clinical study protocol

  • Other cardiovascular diseases as defined by any of the following:

    1. Symptomatic heart failure,
    2. uncontrolled hypertension,
    3. hypertensive heart disease with significant left ventricular hypertrophy
    4. 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.
    5. cardiomyopathy of any etiology
    6. presence of clinically significant valvular heart disease
    7. history of atrial or ventricular arrhythmia requiring treatment; subjects with atrial fibrillation and optimally controlled ventricular rate (< 100 beats per minute) are permitted.
    8. subjects with atrial fibrillation and optimally controlled ventricular rate are permitted
    9. transient ischaemic attack, or stroke within 6 months prior to screening
    10. patients with symptomatic hypotension at screening

  • Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).

  • 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

  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Module 1: AZD5305 Monotherapy

AZD5305 Monotherapy
Geneesmiddel: AZD5305

Oral PARP inhibitor
Experimenteel: Module 2: AZD5305 + Paclitaxel

AZD5305 + Paclitaxel
Geneesmiddel: AZD5305

Oral PARP inhibitor

Geneesmiddel: Paclitaxel

IV Anti-microtubule agent
Experimenteel: Module 3: AZD5305 + Carboplatin with or without Paclitaxel

AZD5305 + Carboplatin with or without Paclitaxel
Geneesmiddel: AZD5305

Oral PARP inhibitor

Geneesmiddel: Paclitaxel

IV Anti-microtubule agent

Geneesmiddel: Carboplatin

IV Platinum chemotherapeutic
Experimenteel: Module 4: AZD5305 + Trastuzumab Deruxtecan

AZD5305 + T- DXd
Geneesmiddel: AZD5305

Oral PARP inhibitor

Geneesmiddel: T- Dxd

IV Antibody-drug conjugate
Experimenteel: Module 5 AZD5305 + Datopotamab Deruxtecan

AZD5305 + Dato-DXd
Geneesmiddel: AZD5305

Oral PARP inhibitor

Geneesmiddel: Dato-DXd

IV Antibody-drug conjugate
Experimenteel: Module 6 AZD5305 + Camizestrant

AZD5305 + Camizestrant
Geneesmiddel: AZD5305

Oral PARP inhibitor

Geneesmiddel: Camizestrant

Oral SERD Molecule

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The number of subjects with adverse events/serious adverse events
Tijdsspanne: 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.

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.
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol.
Tijdsspanne: From first dose of study treatment until the end of Cycle 1.

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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Best percentage change in target lesion
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

Change in target lesion size from baseline, as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Objective Response Rate
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

Best response until progression, as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Duration of Response
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

Time from first response to progression or death , as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Progression Free Survival
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

Time from C1D1 to progression or death, as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Time To Response
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

Time from C1D1 to complete or partial response, as defined by RECIST 1.1.
From Screening to confirmed progressive disease (approximately 1 year)
Effects of AZD5305 on pH2AX (Ser139) PD biomarker
Tijdsspanne: From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)

Measure change from baseline in pH2AX
From Cycle 0 Day 1 to Cycle 1 Day 15 (approximately 21 days)
CA125 response (ovarian cancer)
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

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)
Module 1: Area Under Curve (AUC)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

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)
Module 1: Maximum plasma concentration of the drug (Cmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 1: The time taken to reach the maximum concentration (Tmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 1 and Module 5: Objective Response Rate (prostate cancer)
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

Best response until progression, as defined by RECIST 1.1 or PCWG3 (bone)
From Screening to confirmed progressive disease (approximately 1 year)
Module 1: Radiographic progression free survival (prostate cancer)
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

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)
Module 1: Proportion of subjects with ≥ 50% PSA decrease (prostate cancer)
Tijdsspanne: From Screening to confirmed progressive disease (approximately 1 year)

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)
Module 1 : To investigate the effect of a high-fat meal on the PK of AZD5305
Tijdsspanne: 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.

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.
Module 2: Area Under Curve (AUC)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

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)
Module 2: Maximum plasma concentration of the drug (Cmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 2: The time taken to reach the maximum concentration (Tmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 3: Area Under Curve (AUC)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

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)
Module 3: Maximum plasma concentration of the drug (Cmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 3: The time taken to reach the maximum concentration (Tmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4 : Area Under Curve
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

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)
Module 4: Maximum plasma concentration of the drug (Cmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4: The time taken to reach the maximum concentration (Tmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 4: Anti-Drug Antibody (ADA)
Tijdsspanne: 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

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
Module 4: To assess the preliminary anti-tumour activity of AZD5305 as monotherapy and in combination with T-DXd.
Tijdsspanne: From screening to approximately 6 months

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
Module 5: Area Under Curve
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

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)
Module 5: Maximum plasma concentration of the drug (Cmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Cmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 5: The time taken to reach the maximum concentration (Tmax)
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

The concentration of AZD5305 in plasma will be determined (Tmax will be derived).
At predefined intervals throughout the treatment period (approximately 12 weeks)
Module 5: Anti-Drug Antibody (ADA)
Tijdsspanne: 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.

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.
Module 5: Premilinary anti tumour activity AZD5305 in combination with Dato-DXd
Tijdsspanne: From screening to confirmed progresive disease ( approximately 12 weeks)

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)
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.
Tijdsspanne: At predefined interval throughout the treatment (approximately 12 weeks)

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)
Module 6: To evaluate the effect of camizestrant on the PK of AZD5305.
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

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)
Module 6: To evaluate the effect of AZD5305 on the PK of Camizestrant.
Tijdsspanne: At predefined intervals throughout the treatment period (approximately 12 weeks)

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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

AstraZeneca

Onderzoekers

  • Hoofdonderzoeker: Timothy Yap, M.D. Anderson Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 november 2020

Primaire voltooiing (Geschat)

28 mei 2027

Studie voltooiing (Geschat)

28 mei 2027

Studieregistratiedata

Eerst ingediend

26 oktober 2020

Eerst ingediend dat voldeed aan de QC-criteria

19 november 2020

Eerst geplaatst (Werkelijk)

25 november 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 september 2026

Laatste update ingediend die voldeed aan QC-criteria

18 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • D9720C00001
  • 2020-002688-77 (EudraCT-nummer)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren