#1 Clinical Trials Search in Europe

Palbociclib

Palbociclib, also known as PD-0332991, is an oral medication being studied in clinical trials for various types of cancer. It works by inhibiting specific proteins called cyclin-dependent kinases (CDK) 4 and 6, which are involved in cell division. By blocking these proteins, palbociclib may help stop or slow the growth of cancer cells. This article summarizes key information about ongoing clinical trials investigating palbociclib’s effectiveness and safety in treating different cancers.

Table of Contents

What is Palbociclib?

Palbociclib, also known by its brand name Ibrance, is a medication used in the treatment of certain types of cancer[2]. It belongs to a class of drugs called CDK4/6 inhibitors, which work by targeting specific proteins in cancer cells to slow down or stop their growth[1]. Palbociclib is primarily used in the treatment of advanced breast cancer, but researchers are also studying its potential in other types of cancer.

How Palbociclib Works

Palbociclib works by inhibiting two important proteins in cancer cells called CDK4 and CDK6 (cyclin-dependent kinases 4 and 6)[1]. These proteins play a crucial role in cell division and growth. By blocking their activity, palbociclib can help slow down or stop the growth of cancer cells. This mechanism of action makes palbociclib particularly effective in treating certain types of cancer that rely heavily on these proteins for their growth.

Conditions Treated with Palbociclib

Palbociclib is primarily used to treat the following conditions:

  • Advanced Breast Cancer: Specifically, palbociclib is used in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in postmenopausal women[3]. This type of breast cancer is driven by hormones and does not have high levels of the HER2 protein.
  • Head and Neck Cancer: Researchers are investigating the use of palbociclib in combination with other drugs for the treatment of squamous cell carcinoma of the head and neck (SCCHN)[4].
  • Other Solid Tumors: Clinical trials are exploring the potential of palbociclib in treating other types of solid tumors, including pancreatic cancer[5].

How Palbociclib is Administered

Palbociclib is typically administered as follows:

  • Oral Capsules: Palbociclib is taken by mouth in the form of capsules[6].
  • Dosing Schedule: The usual dosing schedule is 125 mg once daily for 21 consecutive days, followed by 7 days off treatment. This 28-day cycle is then repeated[6].
  • With Food: Palbociclib should be taken with food to ensure proper absorption[4].
  • Continuous Treatment: Patients typically continue taking palbociclib as long as they are benefiting from the treatment and not experiencing severe side effects[7].

Combination Therapies

Palbociclib is often used in combination with other cancer treatments to enhance its effectiveness. Common combination therapies include:

  • Palbociclib + Letrozole: This combination is used for postmenopausal women with HR+, HER2- advanced breast cancer[3]. Letrozole is a type of hormone therapy that helps block the production of estrogen, which can fuel the growth of certain breast cancers.
  • Palbociclib + Fulvestrant: Another combination used in the treatment of HR+, HER2- advanced breast cancer[7]. Fulvestrant is also a hormone therapy that works by blocking and degrading estrogen receptors.
  • Palbociclib + Cetuximab: This combination is being studied for the treatment of head and neck cancer[4]. Cetuximab is a targeted therapy that blocks a protein called EGFR, which is often overactive in head and neck cancers.

Potential Side Effects

Like all medications, palbociclib can cause side effects. Some of the most common side effects reported in clinical trials include:

  • Neutropenia: A decrease in white blood cells, which can increase the risk of infections[6].
  • Fatigue: Feeling tired or weak[6].
  • Nausea and Vomiting[6].
  • Decreased Appetite[6].
  • Hair Loss[6].
  • Diarrhea[6].

It’s important to note that not everyone experiences these side effects, and your healthcare team will monitor you closely during treatment to manage any side effects that may occur.

Ongoing Clinical Trials

Researchers are continuously studying palbociclib to understand its full potential and improve its use in cancer treatment. Some ongoing areas of research include:

  • Combination with Other Therapies: Studies are exploring the effectiveness of palbociclib when combined with various other cancer treatments[1].
  • Use in Different Cancer Types: While primarily used for breast cancer, researchers are investigating palbociclib’s potential in treating other cancers, such as head and neck cancer and pancreatic cancer[4][5].
  • Biomarker Studies: Researchers are looking at specific biomarkers (such as p16 and Rb expression) to identify which patients might benefit most from palbociclib treatment[4].

Impact on Patient Quality of Life

In addition to studying the effectiveness of palbociclib in treating cancer, researchers are also interested in understanding how the medication affects patients’ overall quality of life. Some studies have used questionnaires like the EORTC QLQ-C30 and EORTC QLQ-H&N35 to assess various aspects of patient well-being during treatment[4]. These assessments help healthcare providers better understand the full impact of palbociclib treatment on patients’ daily lives and can inform decisions about treatment plans.

Aspect Details
Drug Name Palbociclib (PD-0332991)
Mechanism of Action Selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6)
Cancer Types Studied Breast cancer, non-small cell lung cancer, acute leukemia, gastrointestinal stromal tumors, brain tumors
Administration Oral, typically 125 mg daily for 21 days, followed by 7 days off
Key Outcomes Measured Progression-free survival, overall survival, tumor response, safety/tolerability
Common Side Effects Low blood cell counts, fatigue, nausea, diarrhea
Biomarkers of Interest Retinoblastoma (RB) protein status, CCND1/2/3 amplification
Combination Therapies Studied with hormone therapies, chemotherapies, and targeted agents

FAQ

  • What types of cancer is palbociclib being studied for? Palbociclib is being investigated for several cancer types, including breast cancer, non-small cell lung cancer, acute leukemia, gastrointestinal stromal tumors, and brain tumors like oligodendroglioma and oligoastrocytoma.
  • How is palbociclib typically administered in clinical trials? In most trials, palbociclib is given orally as a daily dose for 21 days, followed by a 7-day break. This 28-day cycle is repeated as long as the patient is benefiting and tolerating the treatment.
  • What are some common side effects of palbociclib? Common side effects may include low blood cell counts, fatigue, nausea, and diarrhea. However, the full range of side effects is still being studied in clinical trials.
  • How do researchers determine if palbociclib is working? Researchers assess the effectiveness of palbociclib by measuring tumor response (shrinkage), progression-free survival (time without cancer growth), and overall survival. They also monitor for side effects and quality of life impacts.
  • Who might be eligible to participate in a palbociclib clinical trial? Eligibility varies by trial, but often includes patients with specific cancer types that have progressed after standard treatments. Some trials look for certain genetic markers in tumors. Patients must meet health criteria and be willing to comply with study procedures.

Ongoing Clinical Trials on Palbociclib

  • Study of Camizestrant and CDK4/6 Inhibitor for Patients with Advanced Breast Cancer with ESR1 Mutation

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria France Germany Hungary +6

  • Study on the Safety and Effects of Zanidatamab, Palbociclib, and Fulvestrant for Patients with Advanced or Metastatic HER2-Positive, HR-Positive Breast Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Advanced Soft-Tissue Sarcoma: Testing Futibatinib and Drug Combination for Patients with Unresectable or Metastatic Conditions

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study of Dabrafenib and Drug Combination for Patients with Metastatic Non-Clear Cell Kidney Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Palbociclib and Drug Combination for Patients with Hormone Receptor Positive, HER2-Positive Metastatic Breast Cancer

    Not recruiting

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

  • Study Comparing Two Treatment Sequences of CDK4/6 Inhibitors (Abemaciclib, Palbociclib, or Ribociclib) in Hormone Receptor Positive Advanced Breast Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • 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 Palbociclib as an Alternative to Chemotherapy for Older Patients with High-Risk Early Breast Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium France Germany Italy Poland Portugal +1

  • Study Comparing Camizestrant and Palbociclib with Anastrozole and Palbociclib for Patients with ER-Positive, HER2-Negative Advanced Breast Cancer Without Prior Treatment

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Czechia France Germany +7

  • Study comparing giredestrant plus palbociclib versus letrozole plus palbociclib in patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Belgium Denmark France Germany Greece +5

Glossary

  • Cyclin-dependent kinases (CDK): Proteins that play a crucial role in regulating cell division and growth. Palbociclib specifically targets CDK4 and CDK6.
  • 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 either the date of diagnosis or the start of treatment that patients are still alive.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Dose-limiting toxicity (DLT): Side effects severe enough to prevent an increase in the dose of a drug being tested in a clinical trial.
  • Maximum tolerated dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Retinoblastoma protein (RB): A tumor suppressor protein that helps control cell growth and division. Its presence is often important for palbociclib to be effective.
  • Anaplastic: A term used to describe cancer cells that divide rapidly and have little or no resemblance to normal cells.
  • Oligodendroglioma: A type of brain tumor that begins in cells called oligodendrocytes, which support and protect nerve cells.

References

  1. https://clinicaltrials.gov/study/NCT04129151
  2. https://clinicaltrials.gov/study/NCT02499146
  3. https://clinicaltrials.gov/study/NCT02600923
  4. https://clinicaltrials.gov/study/NCT02499120
  5. https://clinicaltrials.gov/study/NCT02501902
  6. https://clinicaltrials.gov/study/NCT02679755
  7. https://clinicaltrials.gov/study/NCT05226871