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AKT Inhibitor

AZD5363 for Cancer

Phase 1
Waitlist Available
Led By Udai Banerji, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged at least 18 years
Specific cancers with mutations or dysregulatory aberrations on the PIK/AKT pathway
Must not have
Severe or uncontrolled systemic diseases, active bleeding diatheses, or active infections including hepatitis B, C, and HIV
Clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal, or significant cardiac interventional procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is to study a new drug's safety, dosage, and how well it works against different types of cancer.

Who is the study for?
This trial is for adults with advanced cancers like breast, ovarian, cervical, endometrial cancer or other solid tumors resistant to standard therapies. Participants must have a measurable lesion and an estimated life expectancy over 12 weeks. They should not have severe systemic diseases, active infections (HIV/Hepatitis), brain metastases requiring steroids, significant heart issues or previous bad reactions to AZD5363.
What is being tested?
The study tests the safety and tolerability of AZD5363 in patients with advanced cancer. It aims to find the right dose and schedule for future use while examining how the body processes this drug and its effectiveness against certain mutations in genes related to cancer growth.
What are the potential side effects?
Potential side effects of AZD5363 may include issues related to glucose metabolism disturbances, bleeding disorders due to uncontrolled systemic diseases, infection risks including hepatitis B/C and HIV reactivation if previously infected, neurological symptoms from untreated brain metastases or worsening cardiac conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My cancer has specific genetic changes in the PIK/AKT pathway.
Select...
I have a tumor that can be measured over time.
Select...
My cancer does not respond to standard treatments or no treatments are available.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe diseases, uncontrolled bleeding, or active infections like hepatitis or HIV.
Select...
I do not have major heart problems, uncontrolled low blood pressure, or recent significant heart procedures.
Select...
I have had a bad reaction to AZD5363 or similar drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2015 Phase 1 trial • 33 Patients • NCT01895946
78%
Diarrhoea
56%
Hyperglycaemia
44%
Nausea
39%
Fatigue
28%
Vomiting
22%
Dry skin
22%
Anaemia
22%
Decreased appetite
22%
Rash
17%
Constipation
17%
Hypokalaemia
11%
Pyrexia
11%
Rash maculo-papular
11%
Dyspnoea
11%
Oedema peripheral
11%
Abdominal pain
11%
Blood bilirubin increased
11%
Electrocardiogram QT prolonged
11%
Musculoskeletal chest pain
6%
Abdominal distension
6%
Glossitis
6%
Mouth ulceration
6%
Rash pruritic
6%
Dysphagia
6%
Mouth haemorrhage
6%
Proctalgia
6%
Palpitations
6%
Pulmonary embolism
6%
Intestinal obstruction
6%
Application site pruritus
6%
Peripheral swelling
6%
Pruritus
6%
Blood lactate dehydrogenase increased
6%
Electrocardiogram T wave inversion
6%
Gastrooesophageal reflux disease
6%
Blood creatinine increased
6%
Hypotension
6%
Skin candida
6%
Hypoglycaemia
6%
Pollakiuria
6%
Oral candidiasis
6%
Stomatitis
6%
Oral pain
6%
Joint injury
6%
Alanine aminotransferase increased
6%
Aspartate aminotransferase increased
6%
Blood alkaline phosphatase increased
6%
Blood creatinine decreased
6%
Hypomagnesaemia
6%
Hyponatraemia
6%
Flank pain
6%
Groin pain
6%
Pain in extremity
6%
Polyuria
6%
Migraine
6%
Restless legs syndrome
6%
Depression
6%
Proteinuria
6%
Gamma-glutamyltransferase increased
6%
Arthralgia
6%
Cough
6%
Dry mouth
6%
Rash macular
6%
Urinary tract infection
6%
Rash papular
6%
Breast oedema
6%
Dyspnoea exertional
6%
Upper respiratory tract congestion
6%
Tumour pain
6%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A
Part B

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Parts E and F, Intermittent dosing with FulvestrantExperimental Treatment1 Intervention
Oral 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.
Group II: Parts A,B,C,D Schedule 2, Intermittent dosingExperimental Treatment1 Intervention
Part 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).
Group III: Parts A and B Schedule 3, Intermittent dosing.Experimental Treatment1 Intervention
Part 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
Group IV: Part A and B Schedule 1, Continuous dosingExperimental Treatment1 Intervention
Part 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD5363
2014
Completed Phase 2
~1380

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,400 Previous Clinical Trials
289,122,447 Total Patients Enrolled
Gaia Schiavon, MSDStudy DirectorAstraZeneca
Udai Banerji, MD, PhDPrincipal InvestigatorInstitute of Cancer Research, United Kingdom
1 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

AZD5363 (AKT Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01226316 — Phase 1
Solid Tumors Research Study Groups: Part A and B Schedule 1, Continuous dosing, Parts A,B,C,D Schedule 2, Intermittent dosing, Parts A and B Schedule 3, Intermittent dosing., Parts E and F, Intermittent dosing with Fulvestrant
Solid Tumors Clinical Trial 2023: AZD5363 Highlights & Side Effects. Trial Name: NCT01226316 — Phase 1
AZD5363 (AKT Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01226316 — Phase 1
~19 spots leftby Nov 2025
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