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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tumour assessment by recist at 6,12,18,24wks then at 12 weekly intervals until discontinuation of study therapy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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My cancer has specific genetic changes in the PIK/AKT pathway.

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I have a tumor that can be measured over time.

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My cancer does not respond to standard treatments or no treatments are available.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ multiple gated acquisition (muga) or echocardiogram assessments to be carried out from screening until study drug discontinuation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~multiple gated acquisition (muga) or echocardiogram assessments to be carried out from screening until study drug discontinuation

This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple gated acquisition (muga) or echocardiogram assessments to be carried out from screening until study drug discontinuation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of adverse events and serious adverse events

Parts A,B,C,D,E & F : Safety and tolerability of AZD5363 in terms of death

Parts A,B,C,D,E & F: Safety and tolerability of AZD5363 by assessing changes from baseline in electrocardiogram (ECG) parameters

+4 more

Secondary outcome measures

Exercise, Aerobic

To characterise AZD5363 PK following single & multiple dosing by assessment of maximum plasma concentration,time to Cmax, terminal rate constant, terminal half life,area under the plasma concentration-time curve,plasma clearance & volume of distribution.

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%

Oedema peripheral

11%

Dyspnoea

11%

Rash maculo-papular

11%

Abdominal pain

11%

Blood bilirubin increased

11%

Electrocardiogram QT prolonged

11%

Musculoskeletal chest pain

Glossitis

Intestinal obstruction

Dysphagia

Proctalgia

Pruritus

Pulmonary embolism

Abdominal distension

Mouth ulceration

Application site pruritus

Mouth haemorrhage

Palpitations

Rash pruritic

Blood lactate dehydrogenase increased

Electrocardiogram T wave inversion

Gastrooesophageal reflux disease

Blood creatinine increased

Hypotension

Skin candida

Hypoglycaemia

Pollakiuria

Oral candidiasis

Stomatitis

Oral pain

Peripheral swelling

Joint injury

Alanine aminotransferase increased

Aspartate aminotransferase increased

Blood alkaline phosphatase increased

Blood creatinine decreased

Hypomagnesaemia

Hyponatraemia

Flank pain

Groin pain

Pain in extremity

Polyuria

Migraine

Restless legs syndrome

Depression

Proteinuria

Gamma-glutamyltransferase increased

Arthralgia

Cough

Dry mouth

Rash macular

Urinary tract infection

Rash papular

Breast oedema

Dyspnoea exertional

Upper respiratory tract congestion

Tumour pain

Hypothyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Part A

Part B

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,617 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has AZD5363 gained the endorsement of the Food and Drug Administration?

"Due to the limited data available, our team at Power has assigned AZD5363 a score of 1 on the safety scale. This is because it's currently in Phase 1 trials and thus only possesses minimal evidence supporting both its efficacy and risk profile."

Answered by AI

Is the research program being conducted in Canada at multiple locations?

"This trial is running at 15 medical sites in Portland, Houston, Nashville and other US cities. To reduce travelling requirements for participants, it's beneficial to select a study location near you."

Answered by AI

Are there open vacancies remaining in this experiment for participants?

"The information on clinicaltrials.gov suggests that recruitment for this trial has been concluded, as the last update was made on September 22nd 2022. Despite that, there is still an abundance of trials enrolling patients at present, with 3214 other medical studies open to volunteers currently."

Answered by AI

Does this study admit participants who are under 70 years of age?

"This medical trial is inviting individuals who are over the age of majority and below the 130-year mark to join."

Answered by AI

Could you enlighten us on the other experiments that have featured AZD5363?

"At this juncture, 21 trials are running for AZD5363, including 4 Phase 3 studies. These experiments span a broad area with Montpellier and Ontario representing just two of the total 4194 trial sites."

Answered by AI

What requirements must be met for potential participants to join this clinical trial?

"This trial seeks to enroll 285 individuals who are at least 18 years of age and with a PIK3CA gene mutation. Crucially, these patients must have ER+/HER2+, breast, ovarian, cervical or endometrial cancer; be resistant to traditional treatments for their condition; possess either an AKT1 gene mutation or dysregulation on the PIK/AKT pathway; have advanced or metastatic ER + positive breast cancer that has a PTEN gene mutation (Part F); live more than 12 weeks after enrollment in this study, and other criteria as outlined in Parts A-F of the protocol."

Answered by AI

Has this sort of experiment been conducted before or is it a pioneering endeavor?

"Since 2010, AstraZeneca has sponsored multiple clinical trials on the drug AZD5363. A Phase 1 study of 285 participants in 2010 preceded its approval as a medication and today there are 21 active studies with locations across 44 countries worldwide."

Answered by AI

What is the current ceiling for recruitment into this clinical experiment?

"Unfortunately, this research has closed its recruitment process. First posted in December 2010 and last updated on September 22 2022, it is no longer accepting applicants. However, 3193 trials for pik3ca are actively recruiting patients as well as 21 studies involving AZD5363 that have open enrolment opportunities."

Answered by AI

Recent research and studies

JCO Precision OncologyJournal

Utility of Serial Cfdna NGS for Prospective Genomic Analysis of Patients on a Phase I Basket Study

Smyth, Lillian M., Jonathan B. Reichel, Jiabin Tang, Juber Ahamad A. Patel, Fanli Meng, Duygu S. Selcuklu, Brian Houck-Loomis, et al.. 2021. “Utility of Serial Cfdna NGS for Prospective Genomic Analysis of Patients on a Phase I Basket Study”. JCO Precision Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/po.20.00184.

akt1Journal

Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients with <i>akt1</i>e17k-mutant, Er-positive Metastatic Breast Cancer

Smyth, Lillian M., Kenji Tamura, Mafalda Oliveira, Eva M. Ciruelos, Ingrid A. Mayer, Marie-Paule Sablin, Laura Biganzoli, et al.. 2020. “Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients with akt1e17k-mutant, Er-positive Metastatic Breast Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-19-3953.

npj Breast CancerJournal

Selective AKT Kinase Inhibitor Capivasertib in Combination with Fulvestrant in Pten-mutant Er-positive Metastatic Breast Cancer

Smyth, Lillian M., Gerald Batist, Funda Meric-Bernstam, Peter Kabos, Iben Spanggaard, Ana Lluch, Komal Jhaveri, et al.. 2021. “Selective AKT Kinase Inhibitor Capivasertib in Combination with Fulvestrant in Pten-mutant Er-positive Metastatic Breast Cancer”. Npj Breast Cancer. Springer Science and Business Media LLC. doi:10.1038/s41523-021-00251-7.

pik3caJournal