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Badanie AZD5305 w monoterapii iw połączeniu ze środkami przeciwnowotworowymi u pacjentów z zaawansowanymi nowotworami litymi (PETRA)

18 września 2026 zaktualizowane przez: AstraZeneca

Modułowe, otwarte, wieloośrodkowe badanie fazy I/IIa oceniające bezpieczeństwo, tolerancję, farmakokinetykę, farmakodynamikę i wstępną skuteczność rosnących dawek AZD5305 w monoterapii i w skojarzeniu z lekami przeciwnowotworowymi u pacjentów z zaawansowanymi nowotworami litymi

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

702

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 130 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Module 1: AZD5305 Monotherapy

AZD5305 Monotherapy

Oral PARP inhibitor

Eksperymentalny: Module 2: AZD5305 + Paclitaxel

AZD5305 + Paclitaxel

Oral PARP inhibitor

IV Anti-microtubule agent

Eksperymentalny: Module 3: AZD5305 + Carboplatin with or without Paclitaxel

AZD5305 + Carboplatin with or without Paclitaxel

Oral PARP inhibitor

IV Anti-microtubule agent

IV Platinum chemotherapeutic

Eksperymentalny: Module 4: AZD5305 + Trastuzumab Deruxtecan

AZD5305 + T- DXd

Oral PARP inhibitor

IV Antibody-drug conjugate

Eksperymentalny: Module 5 AZD5305 + Datopotamab Deruxtecan

AZD5305 + Dato-DXd

Oral PARP inhibitor

IV Antibody-drug conjugate

Eksperymentalny: Module 6 AZD5305 + Camizestrant

AZD5305 + Camizestrant

Oral PARP inhibitor

Oral SERD Molecule

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
The number of subjects with adverse events/serious adverse events
Ramy czasowe: 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.
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Best percentage change in target lesion
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Timothy Yap, M.D. Anderson Cancer Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 listopada 2020

Zakończenie podstawowe (Szacowany)

28 maja 2027

Ukończenie studiów (Szacowany)

28 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

26 października 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 listopada 2020

Pierwszy wysłany (Rzeczywisty)

25 listopada 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .