#1 Clinical Trials Search in Europe

Buparlisib

Buparlisib, also known as BKM120, is an investigational drug being studied in clinical trials for various types of cancer. This article summarizes key information about ongoing and completed clinical trials evaluating buparlisib’s safety and effectiveness in treating different cancers, including lymphomas, lung cancer, and other solid tumors. The trials aim to determine optimal dosing, assess side effects, and measure how well buparlisib works alone or in combination with other cancer treatments.

Table of Contents

What is Buparlisib?

Buparlisib, also known as BKM120, is an investigational drug being studied for the treatment of various types of cancer[1][2]. It is a type of medication called a pan-class I selective phosphoinositide 3-kinase (PI3K) inhibitor. This means it works by blocking certain proteins that are involved in cancer cell growth and survival[2].

How Does Buparlisib Work?

Buparlisib works by shutting down some of the signals in cancer cells that make tumors grow[2]. Specifically, it targets a group of enzymes called PI3K, which are involved in many cellular processes, including cell growth, survival, and metabolism. By inhibiting these enzymes, buparlisib may help slow down or stop the growth of cancer cells[3].

Cancers Treated with Buparlisib

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

  • Primary Central Nervous System Lymphoma (PCNSL) and Secondary Central Nervous System Lymphoma (SCNSL): These are types of lymphoma (cancer of the lymph system) that affect the brain and spinal cord[1].
  • Metastatic Transitional Cell Carcinoma of the Urothelium: This is an advanced form of bladder cancer that has spread to other parts of the body[2].
  • Melanoma with Brain Metastases: This refers to skin cancer that has spread to the brain[4].
  • Head and Neck Squamous Cell Carcinoma (HNSCC): This is a type of cancer that affects the mouth, nose, and throat[5].
  • Non-Small Cell Lung Cancer (NSCLC): This is a common type of lung cancer[6][3].
  • Diffuse Large B-cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), and Follicular Lymphoma (FL): These are different types of blood cancers that affect white blood cells called lymphocytes[7][8].
  • Chronic Lymphocytic Leukemia (CLL): This is a type of blood cancer that affects a specific type of white blood cell[9].

Clinical Trials and Research

Buparlisib is currently being studied in various clinical trials to determine its effectiveness and safety in treating different types of cancer. These trials are typically conducted in phases:

  • Phase I trials focus on finding the right dose and identifying side effects[10].
  • Phase II trials further evaluate the drug’s effectiveness and safety in specific cancer types[7][9].
  • Phase III trials compare the new drug to standard treatments or placebos in larger groups of patients[5].

Researchers are studying various aspects of buparlisib, including its ability to shrink tumors, slow cancer growth, and improve survival rates in patients with different types of cancer[2][4].

Dosage and Administration

In most clinical trials, buparlisib is administered orally as a capsule. The typical dose being studied is 100 mg once daily[1][2]. However, the exact dosage may vary depending on the specific trial and the patient’s condition. It’s important to note that the optimal dose may still be under investigation in some studies[6].

Side Effects and Safety

As with any medication, buparlisib can cause side effects. Common side effects reported in clinical trials include:

  • Fatigue
  • Nausea
  • Diarrhea
  • Decreased appetite
  • Skin rash
  • Mood changes

More serious side effects may also occur. The safety profile of buparlisib is still being evaluated in ongoing clinical trials[5][6]. Patients participating in these trials are closely monitored for any adverse events.

Combination Therapies

Researchers are also studying buparlisib in combination with other cancer treatments to potentially enhance its effectiveness. Some combinations being investigated include:

  • Buparlisib with paclitaxel for head and neck cancer[5]
  • Buparlisib with carboplatin and paclitaxel for non-small cell lung cancer[3]
  • Buparlisib with ibrutinib for certain types of lymphoma[8]

Future Prospects

While buparlisib shows promise in treating various types of cancer, it’s important to remember that it is still an investigational drug. More research is needed to fully understand its effectiveness, safety, and optimal use in cancer treatment. Patients interested in buparlisib should discuss with their healthcare providers about the possibility of participating in clinical trials[1][2].

Aspect Details
Drug Name Buparlisib (BKM120)
Drug Class PI3K inhibitor
Administration Oral, typically once daily
Common Dosage 100 mg daily (varies by trial)
Cancer Types Studied Non-small cell lung cancer, lymphomas, head and neck cancer, melanoma, urothelial carcinoma
Trial Phases Phase I, II, and III
Combination Therapies Docetaxel, paclitaxel, carboplatin
Primary Outcomes Safety, maximum tolerated dose, progression-free survival, overall response rate
Secondary Outcomes Overall survival, duration of response, quality of life, pharmacokinetics
Safety Monitoring Adverse events, laboratory abnormalities, ECG changes, vital signs

FAQ

  • What types of cancer is buparlisib being studied for? Buparlisib is being investigated for several cancer types, including non-small cell lung cancer, lymphomas (such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma, mantle cell lymphoma, and follicular lymphoma), head and neck squamous cell carcinoma, melanoma with brain metastases, and urothelial carcinoma.
  • How is buparlisib administered? Buparlisib is typically given as an oral medication, usually in the form of capsules taken once daily. The dosage varies between trials but is often around 100 mg per day.
  • What are some common side effects of buparlisib? While specific side effects vary between trials, common adverse events monitored include changes in blood cell counts, liver function, mood, and general toxicities. Some trials also assess cardiac effects through ECG monitoring.
  • Is buparlisib used alone or in combination with other drugs? Buparlisib is being studied both as a single agent and in combination with other cancer treatments. Some trials combine it with chemotherapy drugs like docetaxel, paclitaxel, or carboplatin.
  • What is the main goal of these clinical trials? The primary goals of these trials include determining the safety profile of buparlisib, finding the optimal dose, assessing its effectiveness in treating various cancers (often measured by tumor response rates and progression-free survival), and evaluating how it performs compared to existing treatments or placebos.

Ongoing Clinical Trials on Buparlisib

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

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Belgium France Germany Hungary Italy Poland +1

Glossary

  • Buparlisib: An investigational drug that inhibits PI3K (phosphoinositide 3-kinase), a protein involved in cancer cell growth and survival. Also known as BKM120.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects in a clinical trial.
  • Recommended Phase II Dose (RP2D): The dose of a drug determined to be appropriate for further testing in Phase II clinical trials based on safety and efficacy data from Phase I trials.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without the disease getting worse.
  • Overall Response Rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment based on changes in tumor size.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent further dose increases or require a dose reduction in a clinical trial.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Quality of Life (QOL): A measure of an individual's well-being and ability to carry out daily activities while undergoing treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. https://clinicaltrials.gov/study/NCT02301364
  2. https://clinicaltrials.gov/study/NCT01551030
  3. https://clinicaltrials.gov/study/NCT01820325
  4. https://clinicaltrials.gov/study/NCT02452294
  5. https://clinicaltrials.gov/study/NCT01852292
  6. https://clinicaltrials.gov/study/NCT01911325
  7. https://clinicaltrials.gov/study/NCT01693614
  8. https://clinicaltrials.gov/study/NCT02756247
  9. https://clinicaltrials.gov/study/NCT02340780
  10. https://clinicaltrials.gov/study/NCT02048787