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Ipatasertib

Ipatasertib is an investigational drug being studied in clinical trials for various types of cancer, including breast, ovarian, prostate, and solid tumors. This article summarizes key information about ongoing clinical trials evaluating ipatasertib’s safety, effectiveness, and potential use in combination with other cancer treatments. The trials aim to determine optimal dosing, assess side effects, and measure how well ipatasertib works in shrinking tumors or slowing cancer progression.

Table of Contents

What is Ipatasertib?

Ipatasertib is a new drug being studied for the treatment of various types of cancer. It’s also known by other names such as GDC-0068 and RO5532961[1]. This medication is part of a class of drugs called AKT inhibitors, which work by targeting specific processes in cancer cells[2].

How Does Ipatasertib Work?

Ipatasertib works by inhibiting a protein called AKT (also known as protein kinase B). AKT is part of a pathway in cells called the PI3K/AKT pathway, which is often overactive in cancer cells. By blocking AKT, ipatasertib can help slow down or stop the growth of cancer cells[2].

The PI3K/AKT pathway is like a communication system within cells that tells them to grow and divide. In many cancers, this pathway is too active, causing cells to grow and divide uncontrollably. Ipatasertib acts like a roadblock in this communication system, potentially stopping the cancer cells from receiving these growth signals[3].

What Cancers Does Ipatasertib Treat?

Ipatasertib is being studied in several types of cancer, including:

  • Breast cancer: Particularly in patients with advanced or metastatic (spread to other parts of the body) breast cancer[2]
  • Ovarian cancer: Especially in patients whose cancer has become resistant to platinum-based chemotherapy[3]
  • Prostate cancer: Including advanced or metastatic prostate cancer[4]
  • Solid tumors: Various types of solid tumors, particularly those with specific genetic changes in the PI3K/AKT pathway[5]

How is Ipatasertib Administered?

Ipatasertib is typically taken orally (by mouth) in the form of tablets. The dosage and schedule can vary depending on the specific study or treatment plan. In many trials, it’s given once daily for 21 days out of a 28-day cycle[3]. However, the exact dosing may be adjusted based on how well a patient tolerates the medication and how effective it is[2].

Clinical Trials and Research

Ipatasertib is currently being studied in various clinical trials to determine its effectiveness and safety. These trials are investigating ipatasertib alone and in combination with other cancer treatments. Some key areas of research include:

  • Combination therapy: Ipatasertib is being studied in combination with other cancer drugs such as paclitaxel (a chemotherapy drug), atezolizumab (an immunotherapy drug), and targeted therapies like trastuzumab and pertuzumab for HER2-positive breast cancer[3][6][2]
  • Biomarker studies: Researchers are looking at whether certain genetic changes in tumors (like mutations in the PIK3CA gene) might predict how well a patient will respond to ipatasertib[3]
  • Different cancer types: While much research focuses on breast, ovarian, and prostate cancers, studies are also looking at ipatasertib’s potential in other solid tumors[5]

Side Effects and Safety

Like all medications, ipatasertib can cause side effects. Common side effects observed in clinical trials include:

  • Diarrhea: This is one of the most common side effects. Some studies are looking at ways to manage this, such as using preventive medications[2]
  • Nausea and vomiting
  • Fatigue
  • Decreased appetite
  • Skin rash

It’s important to note that not everyone experiences these side effects, and they can vary in severity. Researchers are carefully monitoring the safety of ipatasertib in clinical trials[7].

Future Prospects

Ipatasertib shows promise in the treatment of several types of cancer, particularly those with specific genetic changes. Ongoing research aims to determine which patients are most likely to benefit from this drug and how best to use it in combination with other treatments.

While ipatasertib is not yet approved for general use, the results from these clinical trials will help determine its future role in cancer treatment. Patients interested in treatments involving ipatasertib should discuss potential clinical trial options with their oncologist[6][4].

Aspect Details
Drug Name Ipatasertib (also known as GDC-0068)
Drug Class AKT inhibitor
Administration Oral tablet
Cancer Types Studied Breast, ovarian, prostate, and other solid tumors
Key Combination Therapies Paclitaxel, atezolizumab, rucaparib, docetaxel
Primary Outcomes Measured Safety, pharmacokinetics, objective response rate, progression-free survival
Common Side Effects Nausea, diarrhea, fatigue, changes in blood cell counts
Trial Phases Phase 1, Phase 2

FAQ

  • What is ipatasertib? Ipatasertib is an investigational drug that inhibits a protein called AKT, which is involved in cancer cell growth and survival. It is being studied as a potential treatment for various types of cancer.
  • What types of cancer is ipatasertib being studied for? Clinical trials are evaluating ipatasertib for breast cancer, ovarian cancer, prostate cancer, and other advanced solid tumors.
  • How is ipatasertib given to patients? Ipatasertib is typically given as an oral tablet that patients take daily. The exact dosing schedule may vary between trials.
  • What are some of the side effects being monitored in ipatasertib trials? Trials are monitoring for side effects like nausea, diarrhea, fatigue, and changes in blood cell counts. The studies aim to determine the safety profile and maximum tolerated dose.
  • Is ipatasertib being studied alone or in combination with other drugs? Many trials are studying ipatasertib in combination with other cancer drugs like paclitaxel, atezolizumab, and rucaparib to see if combining treatments improves effectiveness.

Ongoing Clinical Trials on Ipatasertib

  • Continued Cancer Treatment Study with Abiraterone, Ipatasertib, Tiragolumab, and Drug Combination for Patients from Previous Genentech/Roche Trials

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Greece Poland

  • Study on Post-Neoadjuvant Therapy for Early Breast Cancer Using Ipatasertib, Inavolisib, and Atezolizumab for Patients with High-Risk Early Breast Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of ipatasertib with atezolizumab and chemotherapy in women with triple-negative breast cancer before surgery

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • Study on the Effectiveness and Safety of Cyclophosphamide Monohydrate and Drug Combination for Patients with Persistent or Recurrent Rare Epithelial Ovarian Tumors

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Italy Spain

  • Study of Ipatasertib with Trastuzumab and Pertuzumab for Patients with Advanced HER2-Positive Breast Cancer and PIK3CA Mutation

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness of Inavolisib, Atezolizumab, and Entrectinib in Patients with Advanced or Metastatic Solid Tumors

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Denmark France Germany Italy Poland +2

Glossary

  • AKT: A protein involved in cell signaling pathways that regulate cell growth and survival. Ipatasertib works by inhibiting AKT.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • Dose-limiting toxicity: Side effects that are severe enough to prevent further dose increases of a drug in a clinical trial.
  • Maximum tolerated dose: The highest dose of a drug that can be given without causing unacceptable side effects.
  • Objective response rate: The proportion of patients whose cancer shrinks or disappears after treatment.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it is absorbed, distributed, metabolized and excreted.
  • Progression-free survival: The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer treatment works.

References

  1. https://clinicaltrials.gov/study/NCT02536391
  2. https://clinicaltrials.gov/study/NCT04253561
  3. https://clinicaltrials.gov/study/NCT04561817
  4. https://clinicaltrials.gov/study/NCT03840200
  5. https://clinicaltrials.gov/study/NCT04341259
  6. https://clinicaltrials.gov/study/NCT03673787
  7. https://clinicaltrials.gov/study/NCT03341884