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Gedatolisib

Gedatolisib is an investigational drug being studied in clinical trials for the treatment of various types of cancer, particularly breast cancer. This article explores the ongoing research on gedatolisib, its potential benefits, and its use in combination with other cancer therapies. Clinical trials are evaluating gedatolisib’s effectiveness in different cancer types and stages, as well as its safety profile and optimal dosing regimens.

Table of Contents

What is Gedatolisib?

Gedatolisib is an investigational drug being studied for its potential in treating various types of cancer. It is also known by other names such as PF-05212384 and PKI-587[1]. This medication is part of a class of drugs called PI3K/mTOR inhibitors, which means it works by blocking specific proteins that are involved in cancer cell growth and survival[2].

How Does Gedatolisib Work?

Gedatolisib is a potent, reversible dual inhibitor that targets two important proteins in cancer cells:

  • PI3K (phosphoinositide 3-kinase): This protein is involved in cell growth and survival.
  • mTOR (mammalian target of rapamycin): This protein also plays a role in cell growth and metabolism.

By blocking these proteins, gedatolisib may help slow down or stop the growth of cancer cells[2]. This dual action makes gedatolisib a promising candidate for cancer treatment, as it targets multiple pathways that cancer cells use to grow and spread.

What Types of Cancer Does Gedatolisib Treat?

Gedatolisib is being studied for its potential in treating several types of cancer, including:

  • Breast cancer: Particularly in patients with HR-positive (hormone receptor-positive), HER2-negative advanced or metastatic breast cancer[1].
  • Triple-negative breast cancer (TNBC): This is a type of breast cancer that lacks estrogen receptors, progesterone receptors, and HER2 protein[3].
  • Non-small cell lung cancer (NSCLC): Specifically, advanced squamous cell lung cancer[4].
  • Pancreatic cancer[4].
  • Head and neck cancer[4].

It’s important to note that gedatolisib is still in the research phase, and its effectiveness for these cancers is being evaluated through clinical trials.

Clinical Trials and Research

Gedatolisib is currently being studied in various clinical trials to assess its safety and effectiveness. Some key studies include:

  • VIKTORIA-1 trial: This is a Phase 3 study comparing gedatolisib combined with fulvestrant (a hormone therapy) and with or without palbociclib (another targeted therapy) to standard-of-care therapies in patients with HR-positive, HER2-negative advanced breast cancer[1].
  • Combination therapy studies: Researchers are investigating gedatolisib in combination with other drugs such as palbociclib, talazoparib, and darolutamide for various types of cancer[5][6][7].
  • Early-stage breast cancer study: A trial called “GLACIER” is looking at gedatolisib and hydroxychloroquine for preventing breast cancer recurrence in patients with early-stage disease[8].

These trials aim to determine the best ways to use gedatolisib, its optimal dosage, and which patients might benefit most from this treatment.

Administration and Dosage

Gedatolisib is typically administered intravenously (through a vein). The dosage and schedule can vary depending on the specific clinical trial and the type of cancer being treated. Some common dosing regimens include:

  • 180 mg given weekly for 3 weeks, followed by 1 week off[1].
  • 150 mg to 180 mg given weekly[8].

The exact dosage and schedule will be determined by your healthcare team based on your individual case and the specific treatment protocol.

Potential Side Effects

As gedatolisib is still in clinical trials, the full range of potential side effects is not yet known. However, common side effects observed in cancer treatments targeting similar pathways may include:

  • Fatigue
  • Nausea
  • Diarrhea
  • Decreased appetite
  • Changes in blood cell counts

Your healthcare team will monitor you closely for any side effects during treatment and adjust the dosage if necessary[1].

Combination Therapies

Gedatolisib is often studied in combination with other cancer treatments to potentially enhance its effectiveness. Some common combination therapies include:

  • Gedatolisib + Fulvestrant: Fulvestrant is a hormone therapy used in breast cancer treatment[1].
  • Gedatolisib + Palbociclib: Palbociclib is a CDK4/6 inhibitor also used in breast cancer treatment[1].
  • Gedatolisib + Talazoparib: Talazoparib is a PARP inhibitor being studied in combination with gedatolisib for breast cancer[6].
  • Gedatolisib + Darolutamide: This combination is being studied for prostate cancer treatment[7].

These combination therapies aim to target cancer cells through multiple pathways, potentially increasing the effectiveness of treatment.

Aspect Details
Drug Name Gedatolisib (also known as PF-05212384 or PKI-587)
Mechanism of Action Potent, reversible dual inhibitor targeting PI3K and mTOR
Administration Intravenous (IV), typically weekly
Cancer Types Studied Breast cancer (HER2+, triple-negative, HR+/HER2-), lung cancer, pancreatic cancer, head and neck cancer
Combination Therapies Fulvestrant, palbociclib, talazoparib, trastuzumab, paclitaxel, carboplatin
Key Clinical Trials VIKTORIA-1, GLACIER, various Phase 1/2 studies
Primary Outcomes Safety, tolerability, maximum tolerated dose, progression-free survival, objective response rate
Secondary Outcomes Overall survival, duration of response, clinical benefit rate, quality of life measures
Current Status Investigational drug in various phases of clinical trials

FAQ

  • What is gedatolisib? Gedatolisib is an investigational drug that acts as a potent, reversible dual inhibitor targeting phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in cancer cells. It is being studied for its potential to treat various types of cancer, especially breast cancer.
  • What types of cancer is gedatolisib being studied for? Gedatolisib is primarily being studied for breast cancer, including HER2-positive, triple-negative, and hormone receptor-positive breast cancers. It is also being investigated for other solid tumors such as lung cancer, pancreatic cancer, and head and neck cancer.
  • How is gedatolisib administered? Gedatolisib is typically administered intravenously (IV) on a weekly schedule. The dosage and frequency may vary depending on the specific clinical trial and combination therapy being studied.
  • What are some common combination therapies being studied with gedatolisib? Gedatolisib is being studied in combination with various other cancer treatments, including fulvestrant, palbociclib, talazoparib, trastuzumab, and standard chemotherapy drugs like paclitaxel and carboplatin.
  • What are the potential side effects of gedatolisib? As with any investigational drug, the full side effect profile of gedatolisib is still being determined through clinical trials. Researchers are closely monitoring patients for adverse events and evaluating the drug's safety and tolerability in various combinations and dosages.

Ongoing Clinical Trials on Gedatolisib

  • Study of Gedatolisib and Darolutamide Combination Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

Glossary

  • Gedatolisib: An investigational drug that acts as a potent, reversible dual inhibitor targeting phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in cancer cells.
  • PI3K: Phosphoinositide 3 kinase, an enzyme involved in cellular functions such as cell growth, proliferation, and survival.
  • mTOR: Mammalian target of rapamycin, a protein that regulates cell growth, proliferation, and survival.
  • HER2: Human Epidermal Growth Factor Receptor 2, a protein that promotes the growth of cancer cells when overexpressed.
  • Triple-negative breast cancer (TNBC): A type of breast cancer that lacks expression of estrogen receptors, progesterone receptors, and HER2.
  • Hormone receptor-positive breast cancer: Breast cancer that has receptors for either estrogen or progesterone, or both.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Neoadjuvant chemotherapy (NACT): Chemotherapy given before surgery to shrink tumors and make them easier to remove.
  • PARP inhibitor: A type of targeted therapy that blocks the poly (ADP-ribose) polymerase (PARP) enzyme, which helps repair DNA damage in cells.
  • Disseminated tumor cells (DTCs): Cancer cells that have spread from the primary tumor to other parts of the body, such as bone marrow.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Clinical benefit rate (CBR): The percentage of patients who achieve complete response, partial response, or stable disease for a specified period.
  • Dose-limiting toxicity (DLT): Side effects that are severe enough to prevent an increase in the dose of a drug being tested in a clinical trial.

References

  1. https://clinicaltrials.gov/study/NCT05501886
  2. https://clinicaltrials.gov/study/NCT05134922
  3. https://clinicaltrials.gov/study/NCT03243331
  4. https://clinicaltrials.gov/study/NCT03065062
  5. https://clinicaltrials.gov/study/NCT02684032
  6. https://clinicaltrials.gov/study/NCT03911973
  7. https://clinicaltrials.eu/trial/study-of-gedatolisib-and-darolutamide-for-patients-with-metastatic-castration-resistant-prostate-cancer/
  8. https://clinicaltrials.gov/study/NCT03400254