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Protein Kinase Inhibitor

Capivasertib for Cancer

Phase 2
Waitlist Available
Led By Kevin M Kalinsky
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
Patients with hormone receptor positive, defined as estrogen receptor and/or progesterone receptor > 1% by immunohistochemistry, AND HER2 negative unresectable breast cancer, with no overexpression by immunohistochemistry (IHC) or amplification by in-situ hybridization, are allowed to continue fulvestrant or an aromatase inhibitor (anastrozole, letrozole, exemestane) with AZD5363 if patient just progressed on this anti-estrogen therapy. Gonadotrophin releasing hormone (GnRH) agonists (such as leuprolide or goserelin) are allowed. For instance, if the last treatment was letrozole plus goserelin, the patient is allowed to continue the letrozole plus goserelin with AZD5363
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights

Study Summary

This trial is testing the effects of AZD5363 on patients with cancer that has a genetic change called AKT mutation. AZD5363 may block AKT, which is a protein needed for cancer cell growth.

Who is the study for?
This trial is for cancer patients with a specific genetic change called AKT mutation. It's open to those who've met previous MATCH Protocol criteria, have certain types of breast cancer, and are not on strong CYP3A4 or CYP2D6 inhibitors. People with diabetes can join if their condition is under control without insulin or multiple medications.Check my eligibility
What is being tested?
Researchers are testing AZD5363 in this phase II trial to see if it can shrink cancers or stop them from growing by blocking the AKT protein. The study focuses on patients whose cancers have an AKT mutation.See study design
What are the potential side effects?
While the exact side effects aren't listed here, drugs like AZD5363 that target proteins involved in cell growth could potentially cause fatigue, nausea, skin rash, changes in blood sugar levels, and may affect heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My recent ECG showed no significant heart issues.
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My breast cancer is hormone receptor positive, HER2 negative, and has not been removed by surgery.
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I have diabetes or am at risk but my fasting glucose is under 160 mg/dL, I don't use insulin, and I take two or fewer diabetes pills.
Select...
My cancer has an AKT mutation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
6-month Progression-free Survival (PFS) Rate
Progression Free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (capivasertib)Experimental Treatment1 Intervention
Patients receive capivasertib PO BID on days 1-4, 8-11, 15-18, and 22-25. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
2021
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,611 Total Patients Enrolled
Kevin M KalinskyPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
5,018 Total Patients Enrolled

Media Library

Capivasertib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439123 — Phase 2
Cancer Research Study Groups: Treatment (capivasertib)
Cancer Clinical Trial 2023: Capivasertib Highlights & Side Effects. Trial Name: NCT04439123 — Phase 2
Capivasertib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439123 — Phase 2

Frequently Asked Questions

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

To what extent has the recruitment of participants been successful for this research endeavor?

"Unfortunately, the study is not currently accepting new enrollees. It was initially presented on May 31st 2016 and last updated 9/16/2022. For those seeking other suitable studies, there are 4669 clinical trials for neoplasms and plasma cell diseases along with 21 Capivasertib studies that require participants at this time."

Answered by AI

Has Capivasertib been accepted by the FDA?

"Our assessment of Capivasertib's safety is 2, as the drug has passed through Phase 2 clinical trials with evidence suggesting it is safe but no attestations to its efficacy."

Answered by AI

Are there current opportunities for volunteers to join the trial?

"Accurate. The clinical trial registry indicates that this particular research project is not currently recruiting participants, despite being last amended on September 16th 2022. Nevertheless, there are 4690 other trials open to patient enrolment at the time of writing."

Answered by AI

Has this experiment been conducted before, or is it a pioneering endeavor?

"Since 2010, Capivasertib has been subject to ongoing research. AstraZeneca initially sponsored a study with 285 participants that granted it Phase 1 drug approval in the same year. In its wake, 21 clinical trials are currently running worldwide from 961 cities and 44 countries."

Answered by AI

Can you provide information regarding preceding trials involving Capivasertib?

"At present, 21 trials are underway to evaluate the efficacy of Capivasertib. Among these studies, 4 have reached phase 3 and there is a total of 4194 sites participating in the research across Montpellier and Ontario."

Answered by AI
~4 spots leftby Mar 2025