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Small Molecule Inhibitor

AZD4635 for Prostate Cancer (AARDVARC Trial)

Phase 2
Waitlist Available
Led By Christopher J Sweeney, MBBS
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to first documented progression or death from any cause (whichever comes first), up to two years
Awards & highlights

AARDVARC Trial Summary

This study is evaluating whether a drug may help treat prostate cancer.

Eligible Conditions
  • Prostate Cancer

AARDVARC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to first documented progression or death from any cause (whichever comes first), up to two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to first documented progression or death from any cause (whichever comes first), up to two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic Progression Free Survival (rPFS) in Each Arm Separately to Determine the Efficacy of AZD4635 Plus Durvalumab and of AZD4635 Plus Durvalumab Plus Cabazitaxel in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Secondary outcome measures
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Area Under the Plasma Concentration Time Curve From Zero Extrapolated to Infinity (AUCinf)
Area Under the Plasma Concentration Time Curve From Zero to 24 Hours [AUC(0-24)]
+13 more

Side effects data

From 2023 Phase 2 trial • 59 Patients • NCT04089553
45%
Nausea
24%
Fatigue
21%
Decreased appetite
17%
Blood creatinine increased
14%
Urinary tract infection
14%
Constipation
14%
Diarrhoea
14%
Vomiting
14%
Dizziness
10%
Blood alkaline phosphatase increased
10%
Anaemia
10%
Muscular weakness
10%
Oedema peripheral
10%
Insomnia
10%
Abdominal pain
10%
Back pain
7%
Chills
7%
Peripheral sensory neuropathy
7%
Muscle spasms
7%
Confusional state
7%
Hypoxia
7%
Pain
3%
Localised oedema
3%
Skin infection
3%
Tooth infection
3%
Aspartate aminotransferase increased
3%
Infusion site extravasation
3%
Cachexia
3%
Covid-19
3%
Hypertension
3%
Hallucination
3%
Hyperglycaemia
3%
Non-cardiac chest pain
3%
Agitation
3%
Dyspnoea
3%
Lipase increased
3%
Hip fracture
3%
Rash maculo-papular
3%
Procedural pain
3%
Skin laceration
3%
Alanine aminotransferase increased
3%
Amylase increased
3%
Hyperkalaemia
3%
Hyperuricaemia
3%
Hypocalcaemia
3%
Hypokalaemia
3%
Musculoskeletal chest pain
3%
Myalgia
3%
Pain in extremity
3%
Tendonitis
3%
Spinal cord compression
3%
Transient ischaemic attack
3%
Acute kidney injury
3%
Haematuria
3%
Acute respiratory failure
3%
Pneumonitis
3%
Chronic kidney disease
3%
Cough
3%
Dermatitis
3%
Pruritus
3%
Gastrooesophageal reflux disease
3%
Haemorrhoidal haemorrhage
3%
Haemorrhoids
3%
Blood lactate dehydrogenase increased
3%
International normalised ratio increased
3%
Weight decreased
3%
Arthralgia
3%
Sinus tachycardia
3%
Hypoaesthesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)

AARDVARC Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: AZD4635 + durvalumab + cabazitaxelExperimental Treatment3 Interventions
AZD4635 plus durvalumab plus cabazitaxel (Arm B) will consist of participants with mCRPC previously treated with docetaxel and one prior NHA (either abiraterone acetate or enzalutamide but not both (prior apalutamide is not allowed in Arm B).
Group II: Arm A: AZD4635 + durvalumabExperimental Treatment2 Interventions
AZD4635 plus durvalumab (Arm A) will consist of participants with mCRPC previously treated with one or more approved NHAs (eg, abiraterone acetate, enzalutamide, apalutamide and/or darolutamide), and one or more taxanes, or participants who are taxane ineligible.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Cabazitaxel
2014
Completed Phase 3
~1290
AZD4635
2016
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,261 Previous Clinical Trials
288,594,141 Total Patients Enrolled
60 Trials studying Prostate Cancer
27,522 Patients Enrolled for Prostate Cancer
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,796 Total Patients Enrolled
3 Trials studying Prostate Cancer
774 Patients Enrolled for Prostate Cancer
Christopher J Sweeney, MBBSPrincipal InvestigatorDana-Farber Cancer Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.
2020. "A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04495179.
~6 spots leftby Apr 2025
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