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AZD4635 for Prostate Cancer

Phase 2
Waitlist Available
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 pre-dose on day 1 of cycles 1, 3, 5, and every 12 weeks thereafter, and 90 days following the last dose of oleclumab (approximately 22 months)
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of combining AZD4635 with durvalumab or oleclumab in men with prostate cancer.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose on day 1 of cycles 1, 3, 5, and every 12 weeks thereafter, and 90 days following the last dose of oleclumab (approximately 22 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose on day 1 of cycles 1, 3, 5, and every 12 weeks thereafter, and 90 days following the last dose of oleclumab (approximately 22 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Confirmed Objective Response Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response Per Prostate Cancer Working Group 3 (PCWG3) Criteria
Secondary outcome measures
Duration of Response (DoR)
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
+8 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)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)Experimental Treatment2 Interventions
Participants will receive combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until will derive clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.
Group II: Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)Experimental Treatment2 Interventions
Participants will receive monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter will continue to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until will derive clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oleclumab
2015
Completed Phase 2
~880
Durvalumab
2017
Completed Phase 2
~3870
AZD4635
2016
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,605,223 Total Patients Enrolled
59 Trials studying Prostate Cancer
27,463 Patients Enrolled for Prostate Cancer
Charles Drake, MD, PhDStudy ChairColumbia University Medical Center, Herbert Irving Pavilion, New York, NY
Emerson A Lim, MDStudy ChairColumbia University Medical Center, Herbert Irving Pavilion, New York, NY

Frequently Asked Questions

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

Is the enrollment period open to individuals above the age of 18?

"This trial seeks volunteers aged 18 and younger than 130."

Answered by AI

In which geographic areas is this clinical trial currently being conducted?

"This trial is currently operating in 9 different sites, located in Nashville, Chattanooga and New york alongside other locations. To reduce travel time involved with participation, it would be wise to choose the nearest site possible."

Answered by AI

Are any openings available for this experiment?

"According to clinicaltrials.gov, this medical trial is not presently seeking patients; the listing was initially posted on August 29th 2019 and last edited October 14th 2022. Nevertheless, there are 1659 other studies that actively need study participants at present."

Answered by AI

Are there any restrictions on who is eligible to join this clinical experiment?

"This medical study is enrolling 59 individuals with prostate cancer who are aged 18 and above. To be eligible, participants must provide written informed consent prior to any procedures, have a confirmed diagnosis of prostate cancer, undergone standard-of-care therapy that has since progressed, possess an accessible lesion for biopsy should one not exist in the archive tumour tissue sample or PSA reading if small cell carcinoma cannot be measured., demonstrate an Eastern Cooperative Oncology Group performance level 0 or 1 within two weeks before screening period's end; maintain suitable body weight (≥35 kg); agree to contraceptive measures during trial duration plus 3 months after"

Answered by AI

Does AZD4635 pose any potential risks to people's health?

"Based on the evidence available, our team assigned AZD4635 a safety rating of 2. As this is still a Phase 2 trial, there has been some data collected to support its security but none yet for efficacy."

Answered by AI

To what degree has AZD4635 been explored in past research?

"At the present time, there are 333 ongoing studies involving AZD4635. Of these, 52 have advanced to Phase 3 with a large concentration of trials based in Cordoba, Texas; however, 12952 other locations around the world are also running clinical investigations into this medication."

Answered by AI

What advantages does AZD4635 provide in terms of patient care?

"AZD4635 is a common treatment for unresectable stage III non-small cell lung cancer and can also be used to treat metastatic urothelial carcinoma, advance directives, and other conditions."

Answered by AI

What is the total count of participants in this clinical trial?

"Unfortunately, this research endeavour is not currently shipping for volunteers. Despite the initial post date of August 29th 2019 and an update to October 14th 2022, no new participants are being sought after at present time. However, those searching can find 1326 trials actively enrolling prostate cancer patients and 333 studies involving AZD4635 recruiting participants with similar criteria in mind."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer
2019. "An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04089553.
~11 spots leftby Apr 2025
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