What side effects are associated with this type of intervention?

AKT inhibitors, such as AZD5363 and capivasertib, commonly cause side effects including hyperglycemia, rash, and fatigue. In comparison, traditional chemotherapy agents like paclitaxel and carboplatin often result in nausea, fatigue, neuropathy, and hematologic toxicities. Targeted therapies, such as pazopanib, are associated with hypertension, diarrhea, and hepatotoxicities. These side effects highlight the varying toxicity profiles of different cancer treatments.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for cancer treatment, focusing on specific genetic mutations and pathways. For instance, capivasertib, another AKT inhibitor, has shown clinically significant activity in patients with AKT1 E17K-mutated tumors. Additionally, other targeted therapies like pembrolizumab (a PD-1 inhibitor) and axitinib (a VEGFR inhibitor) have been approved for various cancers, demonstrating the FDA's commitment to advancing precision medicine in oncology.

What other types of research exist?

Promising alternatives to AZD5363 for cancer treatment include: 1) TAK-733, an investigational MEK1/2 inhibitor showing antitumor effects in solid tumors. 2) Talazoparib, a PARP inhibitor effective in BRCA-positive breast cancer. 3) Pembrolizumab plus cetuximab, showing efficacy in treatment-refractory metastatic head and neck cancer. 4) Regorafenib, an angiogenic inhibitor used in metastatic osteosarcoma. 5) Acalabrutinib, a BTK inhibitor for relapsed/refractory mantle cell lymphoma.

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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 must have an AKT mutation as determined via the MATCH Master Protocol

Must not have

Patients must not have known hypersensitivity to AZD5363 or compounds of similar chemical or biologic composition

Patients with known KRAS, NRAS, HRAS, or BRAF mutations are not eligible for this protocol, as these mutations may lead to limited response due to resistance

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

No Placebo-Only Group

Summary

This trial tests capivasertib, a drug that blocks a protein needed for cancer cell growth, in patients with advanced cancers that have an AKT mutation. Researchers hope it will shrink or stop the growth of these cancers. Capivasertib has shown effectiveness when used with other treatments for different types of breast cancer.

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.

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.

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 cancer has an AKT mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not allergic to AZD5363 or similar medications.

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My cancer does not have KRAS, NRAS, HRAS, or BRAF mutations.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

6-month Progression-free Survival (PFS) Rate

Progression Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments work by targeting specific pathways and proteins essential for cancer cell growth and survival. AKT inhibitors, like AZD5363, block the AKT protein, reducing tumor growth. Chemotherapy targets rapidly dividing cells, while targeted therapies focus on specific genetic mutations or proteins, such as HER2 in breast cancer. Immunotherapy enhances the immune system's ability to fight cancer. Understanding these mechanisms allows for personalized treatment plans, improving the effectiveness and outcomes for cancer patients.

Stress Granules in the Anti-Cancer Medications Mechanism of Action: A Systematic Scoping Review.Clinical implications of routine genomic mutation sequencing in PIK3CA/AKT1 and KRAS/NRAS/BRAF in metastatic breast cancer.Drug-screening and genomic analyses of HER2-positive breast cancer cell lines reveal predictors for treatment response.