Capivasertib for Liver Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests capivasertib, an experimental drug, to assess its behavior in the body, safety, and tolerability. It includes two groups: individuals with moderate liver problems and those with healthy livers for comparison. Candidates with stable liver issues, specifically Child Pugh class B, and certain bilirubin levels may qualify. Participants must have stopped smoking at least three months before joining. As a Phase 1 trial, this early-stage study primarily focuses on safety. It offers participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that capivasertib is likely to be safe for humans?
Research has shown that capivasertib is generally safe for people with moderate liver problems. Early results indicate no reports of serious liver damage from using capivasertib, reassuring those concerned about major side effects.
However, more studies are needed to fully confirm its safety for people with liver issues. While the drug appears promising, further research is ongoing to ensure its safety for this group.
Prospective trial participants should know that capivasertib has undergone previous human testing, providing some reassurance about its safety.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for liver conditions, which often include lifestyle changes, medications to manage symptoms, or surgery, Capivasertib targets specific pathways involved in cell growth and survival. Researchers are excited about Capivasertib because it acts on the AKT signaling pathway, which is crucial for cancer cell proliferation and survival. This unique mechanism could potentially offer a more effective option for managing liver impairment, especially for patients who have not responded well to traditional therapies. By specifically targeting the pathways that contribute to disease progression, Capivasertib might provide a novel approach with possibly fewer side effects.
What evidence suggests that capivasertib might be an effective treatment for liver impairment?
Research has shown that capivasertib can be effective when used with other treatments. For instance, when combined with FASLODEX® (fulvestrant), capivasertib reduced the risk of disease progression or death by 40% in patients with advanced HR-positive breast cancer compared to a placebo with FASLODEX. However, its effects on patients with moderate liver problems remain unclear due to insufficient data. In this trial, participants with moderate hepatic impairment will receive a single dose of capivasertib, while another group with normal hepatic function will also receive a single dose. The study aims to understand how capivasertib works in people with different liver functions.678910
Are You a Good Fit for This Trial?
This trial is for adults weighing at least 50 kg with a BMI of ≥18 and ≤40. Participants must not smoke, use contraception according to local guidelines, have suitable veins for blood draws, and either have moderate hepatic impairment (Child Pugh class B) or normal liver function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment and Residential
Participants will be resident at the Investigative Site and receive a single oral dose of capivasertib
Follow-up
Participants will return for a follow-up visit to monitor safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Capivasertib
Trial Overview
The study measures how the body processes Capivasertib in those with moderate liver problems compared to those with normal liver function. It also looks at the drug's safety and tolerability.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with moderate hepatic impairment will receive a single dose of capivasertib.
Participants with normal hepatic function will receive a single dose of capivasertib.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Citations
Capivasertib - PMC - NIH
The effect of moderate hepatic impairment (bilirubin greater than 1.5-3 times ULN and any AST) is not fully characterized. Capivasertib has not ...
NDA/BLA Multi-disciplinary Review and Evaluation
limited data in patients with moderate hepatic impairment, capivasertib should be administered to patients with moderate hepatic impairment only if the ...
Capivasertib plus FASLODEX® (fulvestrant) reduced the ...
Results showed capivasertib in combination with FASLODEX demonstrated a 40% reduction in the risk of disease progression or death versus placebo plus FASLODEX.
Capivasertib: uses, dosing, warnings, adverse events, ...
Overall survival results were not mature at the time of primary analysis of progression-free survival; 30% of the patients died. The objective response rate was ...
Population Pharmacokinetics and Exposure–Response ...
These results support the consistent benefit observed with the intermittent capivasertib dosing schedule of 400 mg twice daily, in combination with fulvestrant.
A Phase I Study to Investigate the Pharmacokinetics ...
The purpose of this study is to measure the pharmacokinetics (PK), safety, and tolerability of capivasertib in participants with moderate ...
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theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/37198976/astrazeneca-tests-capivasertib-in-liver-impaired-patients-what-investors-should-watch/AstraZeneca Tests Capivasertib in Liver-Impaired Patients
... Safety of Capivasertib in Participants With Moderate Hepatic Impairment.” The goal is to see how the body handles capivasertib and how safe ...
Capivasertib - LiverTox - NCBI Bookshelf - NIH
Since approval and clinical availability of capivasertib, there have been no published case reports of clinically apparent liver injury with ...
CENTER FOR DRUG EVALUATION AND RESEARCH
4548-3 Conduct a hepatic impairment clinical trial to evaluate the pharmacokinetics and safety of capivasertib in patients with moderate hepatic ...
Regulatory Decision Summary for Truqap
However, dedicated clinical studies are required to determine the safety and tolerability of capivasertib in patients with moderate or severe hepatic impairment ...
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