Recent Updates
Recently added Catalysts

AZD5363

Phase 1

Advanced Solid Malignancy | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment324
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01353781Open Label Phase 1 Study in Japan for Patient With Advanced Solid MalignanciesPHASE1 COMPLETED 39 — — Jun 1, 2011Jul 1, 2014Apr 26, 20161 Japan
NCT01226316Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment SchedulesPHASE1 COMPLETED 285 — — Dec 1, 2010Dec 3, 2024Jun 29, 202534 United States, Canada +8
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally
All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive

To investigate the safety and tolerability of AZD5363 to define a Recommended Dose (RD) when given orally, either as a continuous or an intermittent schedule, for further clinical evaluation when given to Japanese patients with advanced solid malignancies

Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of adverse events and serious adverse events
Adverse events, serious adverse events and deaths will be collected from screening to 28 days after study drug discontinuation.
Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of death
Deaths will be collected from screening to 28 days after study drug discontinuation
Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline of laboratory data (clinical chemistry, haematology, urinalysis)
Laboratory data will be collected from screening to 28 days after study drug discontinuation
Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 in terms of changes from baseline in vital signs and in electrocardiogram (ECG) parameters
Vital signs and ECGs will be recorded from screening to 28 days after study drug discontinuation
Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline in electrocardiogram (ECG) parameters
ECGs will be collected from screening to 28 days after study drug discontinuation.
Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline of glucose laboratory parameters (Urine, serum and plasma glucose, glycosylated haemoglobin).
Glucose parameters will be collected from screening to 28 days after study discontinuation.
Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing left ventricular ejection fraction (LVEF).
Multiple Gated Acquisition (MUGA) or Echocardiogram assessments to be carried out from screening until study drug discontinuation
Secondary Endpoints
To define the maximum tolerated dose (MTD) if possible or biological effective dose in Japanese patients with advanced solid malignancies.
once 2 or more participants experience a DLT a dose level during the study period (within approx 20 months)
To characterise the pharmacokinetics parameters Cmin
PK measurements on Cycle 0 Day 1/2/3 and Cycle 1 Day 1/8/15.
To obtain a preliminary assessment of the anti-tumour activity of AZD5363 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in Japanese patients with advanced solid malignancies
Assessed every 3 weeks for initial 2 cycles and every 6 weeks for later cycles for all subjects after start of study treatment until discontinuation of study treatment or withdrawal of consent.
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD5363EXPERIMENTALAscending doses of AZD5363 administered orally to patients to define the maximum tolerated dose (MTD)
Part A and B Schedule 1, Continuous dosingEXPERIMENTALPart A: Ascending doses of AZD5363 administered orally, every day to define the maximum tolerated dose. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A.
Parts A,B,C,D Schedule 2, Intermittent dosingEXPERIMENTALPart A: Ascending doses of AZD5363 administered orally, twice daily, on a 7-day repeating regimen (4 days on, 3 days off and 2 days on, 5 days off), to define the maximum tolerated dose. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A (4 days on, 3 days off and 2 days on, 5 days off). Part C and D: AZD5363 orally, twice daily on an intermittent regimen (4 days on, 3 days off).
Parts A and B Schedule 3, Intermittent dosing.EXPERIMENTALPart A: Ascending doses of AZD5363 administered orally, twice daily, on an alternative weekly regimen. Initiation of Schedule 3 is dependant on emerging clinical data. Part B: Dose expansion phase, at the defined maximum tolerated dose or recommended dose from Part A
Parts E and F, Intermittent dosing with FulvestrantEXPERIMENTALOral AZD5363 twice daily, 4 days on treatment, 3 days off treatment to cessation of therapy combined with background therapy of fulvestrant at its licensed dose of 500mg intramuscularly on days 1,15,29 and once monthly thereafter to cessation of therapy.
Interventions
NameTypeDescription
AZD5363DRUGPatients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout.
Unlock Study Design Details
Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Aged at least 20 years * Histological or cytological confirmation of a solid malignant tumour, excluding lymphoma, that is refractory to standard therapies or for which no standard therapies exist * At least one lesion (measurable and/or non-measurable) that can be accurately ...

Countries:JapanUnited StatesCanadaDenmarkFranceItalyNetherlandsSingaporeSpainUnited Kingdom
Unlock Eligibility Criteria