AZD5363

DRUG17 trials

Sponsors

AstraZeneca, Velindre NHS Trust, University of Nottingham, UNICANCER, University Hospital Southampton NHS Foundation Trust

Conditions

AKT1AdenocarcinomaAdenocarcinoma of the ProstateAdvanced Breast CancerAdvanced CancerAdvanced Gastric AdenocarcinomaAdvanced Gastric CancerAdvanced Solid Malignancy

Phase 1

Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

CompletedNCT01226316

AstraZenecaAdvanced or Metastatic Breast Cancer, Advanced Solid Malignancy, AKT1 +11

Start: 2010-12-01End: 2024-12-03Updated: 2025-06-29

Open Label Phase 1 Study in Japan for Patient With Advanced Solid Malignancies

CompletedNCT01353781

AstraZenecaAdvanced Solid Malignancy, Advanced Solid Tumor

Start: 2011-06-30End: 2014-07-31Target: 39Updated: 2016-04-26

Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability

CompletedNCT01895946

AstraZenecaAdvanced Solid Malignancy,, Pharmacokinetics, Pharmacodynamics,, Safety and Tolerability, +1

Start: 2013-12-31End: 2015-07-31Updated: 2016-05-25

Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer

Active, not recruitingNCT01992952

Velindre NHS TrustEstrogen Receptor Positive Breast Cancer

Start: 2014-05-07End: 2025-12-31Updated: 2025-11-26

Open Label Phase I/Randomised,Double Blind Phase II Study in mCRPC of AZD5363 In Combination With DP Chemotherapy

CompletedNCT02121639

University Hospital Southampton NHS Foundation TrustProstate Cancer

Start: 2014-01-29End: 2021-09-13Updated: 2022-05-05

Trial of Olaparib in Combination with AZD5363 (ComPAKT)

CompletedNCT02338622

Royal Marsden NHS Foundation TrustAdvanced Cancer

Start: 2014-03-31End: 2017-03-21Updated: 2024-09-26

AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations

CompletedNCT03310541

Memorial Sloan Kettering Cancer CenterAdvanced Solid Tumors, Breast Cancer, Prostate Cancer

Start: 2017-10-11End: 2023-05-03Updated: 2023-05-06

Phase 2

AKT Inhibitor in Oestrogen Positive Breast Cancer

CompletedNCT02077569

University of NottinghamInvasive Breast Cancer

Start: 2014-01-31End: 2017-02-21Updated: 2017-05-04

SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients

CompletedNCT02117167

UNICANCERNon-small Cell Lung Cancer Metastatic

Start: 2014-04-23End: 2023-12-31Updated: 2024-01-10

SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

Active, not recruitingNCT02299999

UNICANCERMetastatic Breast Cancer

Start: 2014-04-07End: 2025-12-31Updated: 2025-01-15

PAKT: AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer

CompletedNCT02423603

Queen Mary University of LondonMetastatic Breast Cancer

Start: 2014-05-14End: 2024-06-30Updated: 2025-03-10

Trial of AZD5363 Plus Paclitaxel /AZD2014 Plus Paclitaxel in Biomarker Negative (PIK3CA/MEK/RAS/TP53/MET) Gastric Adenocarcinoma Patients as Second-line Chemotherapy

TerminatedNCT02449655

Samsung Medical CenterAdvanced Gastric Adenocarcinoma

Start: 2015-02-12End: 2018-07-16Updated: 2019-05-20

Study of AZD5363 in Combination With Paclitaxel, in Advanced Gastric Adenocarcinoma Patients Harboring PIK3CA Mutation and/or PIK3CA Amplification as a Second-line Chemotherapy

CompletedNCT02451956

Samsung Medical CenterAdvanced Gastric Cancer

Start: 2015-01-07End: 2019-05-24Updated: 2019-12-30

A Study of Enzalutamide in Combination With AZD5363 in Patients With mCRPC

Institute of Cancer Research, United KingdomAdenocarcinoma of the Prostate

Start: 2014-12-31End: 2020-03-31Target: 136Updated: 2018-08-08

OLAParib COmbinations

TerminatedNCT02576444

Joseph Paul EderCancer

Start: 2015-11-30End: 2019-11-18Updated: 2022-12-28

National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer

Active, not recruitingNCT02664935

University of BirminghamAdenocarcinoma, Carcinoma, Squamous Cell, Non-Small Cell Lung Cancer

Start: 2015-05-31End: 2025-09-30Updated: 2025-05-21

The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial

Institute of Cancer Research, United KingdomAdvanced Breast Cancer

Start: 2016-12-15End: 2023-11-30Target: 1150Updated: 2019-01-22

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