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AKT Inhibitor
Capivasertib + Docetaxel for Prostate Cancer (CAPItello280 Trial)
Phase 3
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 52 months
Awards & highlights
CAPItello280 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.Check my eligibility
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.See study design
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.
CAPItello280 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly active and doctors expect me to live at least 12 more weeks.
Select...
My cancer has spread to my bones or soft tissues.
Select...
I have a suitable tissue sample from my tumor for testing.
Select...
I am currently on hormone therapy for my cancer.
Select...
I've been treated with advanced hormone therapy for prostate cancer and my disease has progressed.
Select...
My prostate cancer is confirmed and not mainly neuroendocrine or small cell type.
Select...
I can take and keep down pills.
Select...
My prostate cancer is worsening despite hormone therapy.
Select...
I am eligible for treatment with docetaxel and steroids.
CAPItello280 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 52 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 52 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Overall Pain Severity and Pain Interference as assessed by BPI-SF questionnaire
Plasma concentration of capivasertib derived from a population PK model
Radiographic Progression-free Survival (rPFS)
+4 moreOther outcome measures
Body Temperature
Pulse rate (heart rate)
Systolic and diastolic blood pressure
+2 moreSide effects data
From 2012 Phase 3 trial • 5351 Patients • NCT0000378222%
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
CAPItello280 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
4,267 Previous Clinical Trials
288,606,191 Total Patients Enrolled
59 Trials studying Prostate Cancer
26,732 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medications that greatly affect my heart's rhythm.I have not had major surgery in the last 4 weeks, except for minor procedures.I don't have active brain tumors or spinal issues needing steroids.I had cancer before, but it was treated over 2 years ago and is not likely to come back.I have heart issues that could affect my safety in the trial.I am mostly active and doctors expect me to live at least 12 more weeks.I have diabetes needing insulin or my HbA1c is 8.0% or higher.I cannot properly absorb medications due to my stomach or bowel condition.I have been diagnosed with active tuberculosis.My blood and organ function tests show I might not be healthy enough for this trial.I do not have any severe illnesses that my doctor thinks would make it unsafe for me to join the study.My cancer has spread to my bones or soft tissues.I have had a bone marrow or organ transplant.I have lasting side effects from cancer treatment, but they won't get worse with this study's treatment.I have a suitable tissue sample from my tumor for testing.I am currently on hormone therapy for my cancer.I have an active hepatitis infection.I haven't taken certain cancer treatments or strong drugs recently.I've been treated with advanced hormone therapy for prostate cancer and my disease has progressed.I am allergic to capivasertib, docetaxel, or similar drugs.I have not had extensive radiation therapy in the last 4 weeks.My prostate cancer is confirmed and not mainly neuroendocrine or small cell type.I have no health conditions that prevent me from taking docetaxel.I can take and keep down pills.My prostate cancer is worsening despite hormone therapy.I am eligible for treatment with docetaxel and steroids.
Research Study Groups:
This trial has the following groups:- Group 1: placebo + docetaxel
- Group 2: capivasertib + docetaxel
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the docetaxel success rate for patients in the United States?
"Docetaxel is classified as a Level 3 medication, which means that while there is data affirming its efficacy, there have been multiple rounds of clinical trials attesting to its safety."
Answered by AI
Could you please inform me if I am able to join this clinical trial?
"This prostate cancer trial has recruited 790 men ranging from 18 to 130 years old."
Answered by AI
Is this trial limited to those 75 years or younger?
"According to the eligibility requirements set out by the researchers, individuals between 18 and 130 years old may apply to participate in this trial. There are 77 other trials for people under 18 and 1351 trials for people over 65."
Answered by AI
How many different locations are coordinating this trial?
"Currently, 37 medical facilities across the country are enrolling patients for this trial. Some of the cities with participating locations include Los Angeles, White Plains and Dallas. If you enroll, try to select a site closest to you to reduce travel requirements."
Answered by AI
Do we still have the opportunity to enroll in this experiment?
"Yes, this is an active clinical trial that is looking for 790 patients from 37 different sites. The trial was first posted on 3/25/2022 and was most recently edited on 10/20/2022."
Answered by AI
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