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AKT Inhibitor

Capivasertib + Docetaxel for Prostate Cancer (CAPItello280 Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1 and anticipated minimum life expectancy of 12 weeks
Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable or non-measurable)
Must not have
Major surgery (excl. placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, internal stents) within 4 weeks of start of study treatment
Any of the following cardiac criteria: Mean resting corrected QT interval (QTc) >470 msec from 3 consecutive ECGs, Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval, Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure NYHA Grade ≥2, Symptomatic hypotension - systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg, haemodinamic instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 52 months
Awards & highlights
Pivotal Trial

Summary

This trial will compare the effect of two different treatments for metastatic prostate cancer. One group will receive a combination of capivasertib and docetaxel, while the other group will receive docetaxel and a placebo. The goal is to see if adding capivasertib to docetaxel improves survival rates.

Who is the study for?
Men with advanced prostate cancer that's resistant to hormone therapy and has spread, despite previous treatments like abiraterone or enzalutamide. They should be fit for chemotherapy, have no severe heart issues or other serious illnesses, and must not have had certain recent surgeries or other cancer treatments.
What is being tested?
The trial is testing if adding Capivasertib to standard Docetaxel chemotherapy improves survival in men with metastatic castration-resistant prostate cancer compared to placebo plus Docetaxel. All participants will continue hormone therapy alongside the study drugs.
What are the potential side effects?
Capivasertib may cause diarrhea, high blood sugar levels, rash, fatigue and nausea. Docetaxel can lead to low white blood cell counts increasing infection risk, hair loss, nail changes, numbness in fingers/toes and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly active and doctors expect me to live at least 12 more weeks.
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My cancer has spread to my bones or soft tissues.
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I have a suitable tissue sample from my tumor for testing.
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I am currently on hormone therapy for my cancer.
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I've been treated with advanced hormone therapy for prostate cancer and my disease has progressed.
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My prostate cancer is confirmed and not mainly neuroendocrine or small cell type.
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I can take and keep down pills.
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My prostate cancer is worsening despite hormone therapy.
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I am eligible for treatment with docetaxel and steroids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery in the last 4 weeks, except for minor procedures.
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I have heart issues that could affect my safety in the trial.
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I have diabetes needing insulin or my HbA1c is 8.0% or higher.
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I cannot properly absorb medications due to my stomach or bowel condition.
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I have been diagnosed with active tuberculosis.
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I have had a bone marrow or organ transplant.
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I have an active hepatitis infection.
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I am allergic to capivasertib, docetaxel, or similar drugs.
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I have no health conditions that prevent me from taking docetaxel.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 52 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 52 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Survival (OS) in the overall population
Secondary study objectives
Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire in the overall population
Overall Survival (OS) in patients with mCRPC and PTEN-deficient tumours (IHC).
Overall Survival (OS) in patients with mCRPC and PTEN-proficient tumours (IHC)
+7 more
Other study objectives
Body Temperature
Pulse rate (heart rate)
Systolic and diastolic blood pressure
+2 more

Side effects data

From 2012 Phase 3 trial • 5351 Patients • NCT00003782
22%
Febrile neutropenia
12%
Fatigue
11%
Infections and infestations - Other, specify
9%
Nausea
8%
Vomiting
8%
Myalgia
7%
Arthralgia
4%
Diarrhea
1%
Hyperglycemia
1%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Doxorubicin + Cyclophosphamide, Then Docetaxel
Doxorubicin + Docetaxel
Doxorubicin + Docetaxel + Cyclophosphamide

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: capivasertib + docetaxelExperimental Treatment2 Interventions
Participants receive capivasertib in combination with docetaxel and steroids on a background of ADT.
Group II: placebo + docetaxelPlacebo Group2 Interventions
Participants receive placebo in combination with docetaxel and steroids on a background of ADT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
docetaxel
2015
Completed Phase 3
~7230

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,411 Previous Clinical Trials
289,122,056 Total Patients Enrolled
56 Trials studying Prostate Cancer
24,447 Patients Enrolled for Prostate Cancer

Media Library

Capivasertib (AKT Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05348577 — Phase 3
Prostate Cancer Research Study Groups: placebo + docetaxel, capivasertib + docetaxel
Prostate Cancer Clinical Trial 2023: Capivasertib Highlights & Side Effects. Trial Name: NCT05348577 — Phase 3
Capivasertib (AKT Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348577 — Phase 3
~418 spots leftby Dec 2026
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