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Protein Kinase Inhibitor

AZD5363 for Prostate Cancer

Phase 1
Waitlist Available
Led By Alison Schram, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Life expectancy of ≥ 12 weeks
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will study the recommended dose of AZD5363 in patients with specific AKT mutations, in combination with standard breast cancer (fulvestrant) or prostate cancer (enzalutamide) drugs.

Eligible Conditions
  • Solid Tumors
  • Prostate Cancer
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are expected to live for at least 12 more weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of patients with an objective response rate (ORR) of AZD5363

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%
Dyspnoea
11%
Rash maculo-papular
11%
Oedema peripheral
11%
Pyrexia
11%
Abdominal pain
11%
Blood bilirubin increased
11%
Electrocardiogram QT prolonged
11%
Musculoskeletal chest pain
6%
Rash pruritic
6%
Proctalgia
6%
Glossitis
6%
Mouth ulceration
6%
Application site pruritus
6%
Abdominal distension
6%
Pulmonary embolism
6%
Mouth haemorrhage
6%
Intestinal obstruction
6%
Pruritus
6%
Palpitations
6%
Dysphagia
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%
Peripheral swelling
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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Prostate, Previously treated with EnzalutamideExperimental Treatment2 Interventions
28-DAY CYCLE AZD5363 400mg PO twice daily for 4 days on, 3 days off, every week + Enzalutamide 160 mg PO once daily
Group II: ER+ Breast, Previously treated with FulvestrantExperimental Treatment2 Interventions
28-DAY CYCLE AZD5363 400mg PO twice daily for 4 days on, 3 days off, every week + Fulvestrant 500mg IM days 1, 15, 29 (cycle 2 day 1) and then every 4 weeks
Group III: Advanced Solid TumorsExperimental Treatment1 Intervention
28-DAY CYCLE AZD5363 480mg PO twice daily for 4 days on, 3 days off, every week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
AZD5363
2014
Completed Phase 2
~1380
Fulvestrant
2011
Completed Phase 3
~3700

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,796 Total Patients Enrolled
131 Trials studying Prostate Cancer
65,892 Patients Enrolled for Prostate Cancer
Alison Schram, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
250 Total Patients Enrolled

Frequently Asked Questions

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

What medical conditions is AZD5363 typically employed to alleviate?

"AZD5363 is the recommended treatment for pik3ca gene mutation, but has also been used in cases of malignant neoplasms, disease progression and castration."

Answered by AI

Is this experimental treatment still taking on new participants?

"This trial is no longer recruiting, having been initially posted on October 11th 2017 and last edited on July 5th 2022. On the other hand, 5046 clinical trials for breast cancer are currently seeking patients as well as 244 studies concerning AZD5363."

Answered by AI

How trustworthy is AZD5363 to ensure patient safety?

"Because this is a Phase 1 trial, meaning that there has been limited safety and efficacy data collected thus far, our team at Power rated AZD5363 as a '1' in terms of its perceived safety."

Answered by AI

How many participants are enrolled in this research endeavor?

"This research endeavour is no longer accepting applications. First posted on October 11th 2017, the project was last edited on July 5th 2022. Those seeking similar trials can find 5046 studies related to breast cancer and 244 involving AZD5363 actively enrolling patients at this time."

Answered by AI

Are there any other research endeavors that have utilized AZD5363?

"Currently, 244 studies analyzing AZD5363 are underway. Of these active trials, 64 have entered Phase 3. Shanghai is the primary location for this research; however, 15339 medical sites globally are trialing it as well."

Answered by AI
~2 spots leftby Mar 2025