Capivasertib

Capivasertib, a promising drug in cancer research, is currently being studied in various clinical trials for its potential to treat different types of cancer. These trials aim to evaluate the drug’s effectiveness, safety, and how it interacts with other medications. The studies focus on breast cancer, lymphoma, and other solid tumors, offering hope for patients with advanced or resistant forms of these diseases.

Table of Contents

What is Capivasertib?

Capivasertib, also known as AZD5363 or Truqap, is a promising new drug being studied for the treatment of various types of cancer[2]. It is a type of medication called a kinase inhibitor, which means it works by blocking certain proteins in cancer cells that help them grow and survive[1].

How Capivasertib Works

Capivasertib specifically targets and inhibits a protein called AKT (also known as protein kinase B). AKT is an important part of a signaling pathway in cells that can become overactive in cancer, leading to uncontrolled cell growth and survival. By blocking AKT, capivasertib aims to slow down or stop the growth of cancer cells[2][3].

Cancers Treated with Capivasertib

Capivasertib is being studied in clinical trials for several types of cancer, including:

  • Breast cancer: Particularly for patients with hormone receptor-positive (HR+) and HER2-negative breast cancer, as well as triple-negative breast cancer (TNBC)[3][4]
  • Prostate cancer: Specifically for patients with metastatic castration-resistant prostate cancer (CRPC)[5]
  • Lymphoma: Including various types of B-cell non-Hodgkin lymphoma[1]
  • Other solid tumors: Capivasertib is being investigated in patients with various advanced solid tumors[6]

Clinical Trials and Research

Capivasertib is currently being studied in several clinical trials to determine its effectiveness and safety. Some key areas of research include:

  • Combination therapy: Capivasertib is being tested in combination with other cancer treatments, such as hormone therapies (fulvestrant) for breast cancer and chemotherapy (paclitaxel) for triple-negative breast cancer[7][4]
  • Biomarker studies: Researchers are looking at whether certain genetic changes in tumors, such as AKT mutations, can predict which patients will respond best to capivasertib[2]
  • Early detection of cancer recurrence: One study is investigating whether capivasertib can help prevent cancer recurrence in patients who have detectable cancer DNA in their blood after initial treatment[3]

Administration and Dosing

Capivasertib is typically given as an oral medication (taken by mouth) in the form of tablets. The dosing schedule can vary depending on the specific clinical trial and cancer type, but common schedules include:

  • Taking the medication twice daily for 4 days, followed by 3 days off[1]
  • Taking the medication twice daily for 4 days each week, with 3 days off, as part of a 28-day cycle[4]

The exact dose may be adjusted based on how well a patient tolerates the medication and their individual response to treatment.

Side Effects and Safety

As with all cancer treatments, capivasertib can cause side effects. While the full safety profile is still being studied in clinical trials, some potential side effects may include:

  • Fatigue
  • Nausea
  • Diarrhea
  • Changes in blood sugar levels
  • Skin rash

It’s important to note that not all patients will experience these side effects, and the severity can vary. Researchers are closely monitoring the safety and tolerability of capivasertib in ongoing clinical trials[8].

Future Prospects

Capivasertib shows promise in the treatment of various cancers, particularly in combination with other therapies. Ongoing research aims to:

  • Determine the most effective dosing schedules and combinations with other treatments
  • Identify which patients are most likely to benefit from capivasertib based on genetic markers in their tumors
  • Explore its potential in preventing cancer recurrence in high-risk patients

As clinical trials progress, more information will become available about the effectiveness and safety of capivasertib in different cancer types and treatment settings[3][4].

Aspect Details
Drug Name Capivasertib (also known as AZD5363)
Mechanism of Action Selective inhibitor of AKT/PKB (protein kinase B) pathway
Cancer Types Studied Breast cancer (HR+/HER2-), B-cell non-Hodgkin lymphoma, advanced solid tumors
Administration Oral, typically 400mg twice daily, 4 days on/3 days off in 28-day cycles
Combination Therapies Fulvestrant, Paclitaxel
Key Outcome Measures Progression-free survival, Overall survival, Objective response rate, Time to next treatment
Biomarkers ctDNA levels, PIK3CA/AKT1/PTEN alterations
Safety Assessments Adverse events, Serious adverse events, Quality of life measures

Ongoing Clinical Trials on Capivasertib

  • A Study Comparing RLY-2608 and Fulvestrant with Capivasertib and Fulvestrant for Patients with PIK3CA-Mutant Hormone Receptor Positive, HER2-Negative Advanced Breast Cancer

    Recruiting

    1 1 1 1
    Austria Belgium Bulgaria Czechia Denmark France +8
  • Study on the Safety and Effectiveness of Capivasertib and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer After Hormone Treatment

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Germany Portugal
  • Study on Personalized Treatment for Hormone Receptor Positive HER2 Negative Breast Cancer Using Capivasertib, Letrozole, and Bevacizumab for Eligible Patients

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Norway
  • Study of Capivasertib and Fulvestrant for Patients with High-Risk Lobular Breast Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany
  • Study on the Effectiveness of Abiraterone, Capivasertib, and Enzalutamide in Patients with Metastatic Prostate Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Belgium Norway Sweden
  • Study of Capivasertib with CDK4/6 Inhibitors and Fulvestrant for Patients with Advanced HR+/HER2- Breast Cancer

    Recruiting

    1 1 1 1
    Belgium Denmark France Germany Italy Poland +2
  • Study on Everolimus and Drug Combination for Children with Relapsed or Refractory Pediatric Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Denmark France Italy The Netherlands Spain
  • Personalizing treatment for patients with HR-positive, HER2-negative metastatic breast cancer using fulvestrant, elacestrant, capivasertib, capecitabine, or a drug combination.

    Not yet recruiting

    1 1 1
    Italy
  • Study on the Safety and Effects of Trastuzumab Deruxtecan with Drug Combination for Patients with Metastatic HER2-low Breast Cancer

    Not recruiting

    1 1 1
    Belgium
  • Study of capivasertib tablets in patients with relapsed or refractory B-cell non-Hodgkin lymphoma

    Not recruiting

    1 1 1
    Investigated drugs:
    Spain

Glossary

  • AKT pathway: A cellular signaling pathway that plays a crucial role in regulating cell survival, growth, and metabolism. It is often overactive in cancer cells.
  • Circulating tumor DNA (ctDNA): Fragments of DNA from cancer cells that can be found in the bloodstream. It can be used as a biomarker to detect and monitor cancer.
  • Endocrine therapy: A type of cancer treatment that adds, blocks, or removes hormones to slow or stop the growth of cancer cells that use hormones to grow.
  • Fulvestrant: A type of hormone therapy used to treat certain types of breast cancer in postmenopausal women.
  • HER2-negative: Refers to breast cancer cells that do not have a high amount of a protein called HER2 on their surface.
  • Hormone receptor-positive (HR+): Describes cancer cells that have receptors for either estrogen or progesterone, allowing these hormones to promote cancer growth.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.

References

  1. https://clinicaltrials.gov/study/NCT05008055
  2. https://clinicaltrials.gov/study/NCT04439123
  3. https://clinicaltrials.gov/study/NCT06613516
  4. https://clinicaltrials.eu/trial/study-of-capivasertib-and-paclitaxel-for-patients-with-advanced-or-metastatic-triple-negative-breast-cancer/
  5. https://clinicaltrials.gov/study/NCT04087174
  6. https://clinicaltrials.gov/study/NCT04742036
  7. https://clinicaltrials.gov/study/NCT06635447
  8. https://clinicaltrials.gov/study/NCT04958226