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Study of Buparlisib and Paclitaxel for Patients with Recurrent or Metastatic Head and Neck Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called recurrent or metastatic head and neck squamous cell carcinoma. This is a condition where cancer cells form in the tissues of the head and neck and have either returned after treatment or spread to other parts of the body. The study is testing a combination of two treatments: Buparlisib (also known by its code name AN2025) and Paclitaxel, compared to using Paclitaxel alone. Buparlisib is taken orally in the form of capsules or tablets, while Paclitaxel is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to see if the combination of Buparlisib and Paclitaxel can help patients live longer compared to Paclitaxel alone. Participants in the study will receive either the combination treatment or Paclitaxel by itself. The study will last for a period of up to 60 days, during which the effects of the treatments will be monitored. Patients will be closely observed to understand how the treatments affect their cancer and overall health.

Throughout the study, researchers will collect information on how well the treatments work and any side effects that may occur. This includes looking at how long patients live, how the cancer responds to the treatment, and how long any positive effects last. The study will also explore the safety of the treatments by monitoring any adverse effects and conducting regular laboratory tests. Additionally, researchers will investigate certain biological markers to gain more insights into the disease and treatment responses.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, medical history, and current health status.

    Informed consent is required before any study-related activities begin.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current state of health and to collect necessary medical information.

    This includes providing tumor tissue for biomarker analysis and ensuring adequate bone marrow and organ function.

  3. Step 3

    Treatment phase

    The treatment phase involves the administration of paclitaxel and buparlisib.

    Paclitaxel is given as a 6 mg/ml solution for infusion through intravenous use.

    Buparlisib is administered orally in various forms: 10 mg capsules, 40 mg tablets, 50 mg tablets, and 50 mg capsules.

    The specific dosage and frequency of administration are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment and to track any side effects.

    This includes clinical laboratory tests and evaluations of overall response rate, progression-free survival, and duration of response.

  5. Step 5

    Completion of study

    The study is estimated to conclude by April 25, 2025.

    Upon completion, final assessments are conducted to evaluate the overall survival and other outcomes.

Who can join the trial?

18 criteria

  • Must be at least 18 years old.
  • Must use highly effective birth control during the study and after the last dose of the study treatment.
  • Must be able to give informed consent before any study-related activities.
  • Must have a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) through tissue examination.
  • Must have tumor tissue available for biomarker analysis, either from past samples or new ones.
  • Must have disease that has worsened or returned after treatment with PDL1/PD1 therapy for recurrent or metastatic disease.
  • Must have received no more than two previous treatments for recurrent or metastatic HNSCC. Treatments used only to enhance radiation therapy do not count.
  • Must have measurable disease as per specific guidelines. If the only measurable disease is in an area previously treated with radiation, there must be proof of disease progression and a four-week gap since the end of radiation therapy.
  • Must have adequate bone marrow and organ function, shown by specific blood and organ tests, including:
    • Enough white blood cells (absolute neutrophil count) and platelets, which can be supported by transfusion if needed.
    • Hemoglobin levels of at least 9 g/dL, which can be reached by transfusion.
    • Normal blood clotting ability (INR ≤ 1.5).
    • Normal calcium levels, or slightly low levels if not considered significant by the doctor. Patients taking medications for calcium correction are eligible.
    • Normal potassium and magnesium levels, or levels acceptable to the doctor.
    • Liver enzymes (AST and ALT) within acceptable limits, even if liver metastases are present.
    • Normal bilirubin levels, or slightly elevated levels if liver metastases are present, or specific conditions like Gilbert's Syndrome are met.
    • Normal kidney function, shown by serum creatinine levels or creatinine clearance.
    • HbA1c (a measure of blood sugar control) of 8% or less.
    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, indicating the ability to carry out daily activities with minimal symptoms.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not experienced a return or spread of their head and neck cancer.
  • Patients who are not able to take the study medications due to allergies or other medical reasons.
  • Patients who are currently participating in another clinical trial.
  • Patients who are pregnant or breastfeeding.
  • Patients who have certain medical conditions that might interfere with the study, such as severe heart problems.
  • Patients who have had another type of cancer within the last 5 years, except for some skin cancers or in situ cervical cancer, which is a very early stage of cervical cancer.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of certain mental health conditions that are not well controlled.
  • Patients who have a history of drug or alcohol abuse within the last 6 months.
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Investigated drugs

  • Buparlisib (AN2025)

    is a medication being studied for its potential to improve survival in patients with head and neck squamous cell carcinoma that has returned or spread to other parts of the body. It is being tested in combination with another drug to see if it can enhance treatment effectiveness.

  • Paclitaxel

    is a chemotherapy drug commonly used to treat various types of cancer, including head and neck cancer. In this study, it is used both alone and in combination with buparlisib to compare the outcomes and determine if the combination offers any additional benefits.

What is already known about the treatment

  • Buparlisib

    Buparlisib is administered orally and is currently being studied in clinical trials for its effectiveness in treating recurrent or metastatic head and neck squamous cell carcinoma. It is not yet widely used in standard medical practice but is gaining attention in medical literature for its potential benefits. The main therapeutic indication is for patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma. Buparlisib works by inhibiting a specific enzyme in cancer cells, which is part of the PI3K pathway, leading to reduced tumor growth. It is classified as a PI3K inhibitor in pharmacology.

  • Paclitaxel

    Paclitaxel is administered intravenously and is a well-established medication in the treatment of various cancers, including head and neck squamous cell carcinoma. It is widely recognized in medical literature and is commonly used in clinical settings. The main therapeutic indication is for treating different types of cancer, including recurrent or metastatic head and neck squamous cell carcinoma. Paclitaxel works by stabilizing the structure of microtubules in cells, preventing them from dividing and thus inhibiting cancer cell growth. It is classified as a mitotic inhibitor in pharmacology.

Investigated diseases

Recurrent or metastatic head and neck squamous cell carcinoma – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck. It is characterized by its ability to recur after initial treatment or spread to other parts of the body, known as metastasis. The disease often affects areas such as the mouth, throat, and voice box. As it progresses, it can lead to symptoms like persistent sore throat, difficulty swallowing, and changes in voice. The progression of the disease can vary, with some cases remaining localized while others spread to distant organs. Understanding the behavior of this cancer is crucial for managing its impact on the patient's quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517251-12-00Protocol codeAN2025H0301Estimated enrolment487 patientsSponsorAdlai Nortye USA Inc.

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