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Napabucasin

Napabucasin, also known as BBI-608, is an investigational drug being studied in various clinical trials for its potential in treating different types of cancer. These trials aim to evaluate the safety, efficacy, and optimal dosing of Napabucasin, both as a standalone treatment and in combination with other cancer therapies. The drug is being tested in patients with advanced malignancies, including colorectal cancer, pancreatic cancer, and non-small cell lung cancer.

Table of Contents

What is Napabucasin?

Napabucasin, also known as BBI608, BBI-608, or BB608, is an experimental cancer drug that is being studied for its potential to treat various types of advanced cancers[1]. It is considered a cancer stemness inhibitor, which means it targets cancer stem cells – a type of cell believed to be responsible for cancer growth and spread[2].

How Napabucasin Works

Napabucasin works by targeting specific pathways in cancer cells, particularly those involved in cancer stem cell function. One of the key targets is a protein called STAT3, which is thought to play a role in cancer cell survival and growth[2]. By inhibiting these pathways, napabucasin may help to slow down or stop cancer progression.

Cancers Treated with Napabucasin

Napabucasin is being studied in clinical trials for several types of advanced cancers, including:

  • Colorectal cancer: This is cancer that starts in the colon or rectum[3]
  • Non-small cell lung cancer: A type of lung cancer that is the most common form of the disease[2]
  • Pancreatic cancer: Cancer that begins in the pancreas, an organ behind the stomach[4]
  • Hepatocellular carcinoma: The most common type of liver cancer[5]
  • Glioblastoma: An aggressive type of brain cancer[6]

Combination Therapies

Napabucasin is often studied in combination with other cancer treatments. Some of the combinations being investigated include:

  • Napabucasin with paclitaxel (a chemotherapy drug)[2]
  • Napabucasin with FOLFIRI (a combination chemotherapy regimen)[3]
  • Napabucasin with nab-paclitaxel and gemcitabine (chemotherapy drugs)[4]
  • Napabucasin with sorafenib (a targeted therapy drug)[5]
  • Napabucasin with temozolomide (a chemotherapy drug)[6]
  • Napabucasin with pembrolizumab (an immunotherapy drug)[7]

These combinations are being tested to see if they can improve the effectiveness of treatment compared to using the drugs alone.

Administration and Dosage

Napabucasin is typically taken orally (by mouth) in the form of tablets or capsules. The dosage and frequency can vary depending on the specific clinical trial and the type of cancer being treated. Some common dosing regimens include:

  • 240 mg twice daily[8]
  • 480 mg twice daily (960 mg total daily dose)[3]

It’s important to note that these dosages are still being studied, and the optimal dose may vary for different patients and cancer types.

Clinical Trials and Research

Napabucasin is currently being studied in various phases of clinical trials, from early Phase 1 studies to larger Phase 3 trials. These studies are designed to evaluate:

  • The safety and side effects of napabucasin
  • How well it works against different types of cancer
  • The best ways to combine it with other treatments
  • How it affects patients’ quality of life

Researchers are also looking at biomarkers (biological indicators) that might help predict which patients are most likely to benefit from napabucasin treatment[2].

Side Effects and Safety

As with all cancer treatments, napabucasin can cause side effects. The full range of potential side effects is still being studied, but some that have been reported in clinical trials include:

  • Diarrhea
  • Nausea
  • Fatigue
  • Decreased appetite

The severity and frequency of these side effects can vary depending on the dosage and whether napabucasin is given alone or in combination with other drugs. It’s important for patients to discuss potential side effects with their healthcare team[4].

It’s worth noting that napabucasin is still an experimental drug and is not yet approved for general use outside of clinical trials. Patients interested in this treatment should speak with their oncologist about the possibility of participating in a clinical trial.

Aspect Details
Drug Name Napabucasin (BBI-608)
Cancer Types Studied Colorectal, Pancreatic, Non-small cell lung cancer, Advanced malignancies
Administration Oral, typically twice daily
Dosage Range 240 mg to 500 mg twice daily
Combination Therapies Paclitaxel, FOLFIRI, Pembrolizumab, Nab-paclitaxel, Gemcitabine
Primary Outcomes Overall Survival, Progression-Free Survival, Safety, Efficacy
Secondary Outcomes Pharmacokinetics, Pharmacodynamics, Quality of Life, Biomarker analysis
Trial Phases Phase I, II, and III

FAQ

  • What is Napabucasin? Napabucasin, also known as BBI-608, is an investigational drug being studied for its potential in treating various types of cancer. It is believed to work by targeting cancer stem cells.
  • What types of cancer is Napabucasin being tested for? Napabucasin is being studied in clinical trials for several types of cancer, including colorectal cancer, pancreatic cancer, non-small cell lung cancer, and other advanced malignancies.
  • How is Napabucasin administered? In most trials, Napabucasin is administered orally, typically twice daily. The dosage varies between studies, ranging from 240 mg to 500 mg twice daily.
  • Is Napabucasin used alone or in combination with other treatments? Napabucasin is being studied both as a standalone treatment and in combination with other cancer therapies such as chemotherapy drugs (e.g., paclitaxel, FOLFIRI) and targeted therapies (e.g., pembrolizumab).
  • What are the main goals of these clinical trials? The main goals of these trials are to assess the safety and efficacy of Napabucasin, determine the optimal dosing, evaluate its effects on overall survival and progression-free survival, and study its pharmacokinetics and pharmacodynamics in cancer patients.

Ongoing Clinical Trials on Napabucasin

  • Study on Napabucasin, Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer After Chemotherapy Failure

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Spain

  • Study on Napabucasin with FOLFIRI for Adults with Metastatic Colorectal Cancer After Standard Treatments

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France Spain

Glossary

  • Napabucasin: An investigational drug, also known as BBI-608, being studied for its potential in treating various types of cancer by targeting cancer stem cells.
  • FOLFIRI: A chemotherapy regimen that combines the drugs FOLinic acid (leucovorin), Fluorouracil (5-FU), and IRInotecan.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without the disease getting worse.
  • Overall Survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Pharmacodynamics: The study of the biochemical and physiological effects of drugs on the body and the mechanisms of drug action.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a decrease in dose.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Disease Control Rate (DCR): The percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease.
  • RECIST: Response Evaluation Criteria In Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.

References

  1. https://clinicaltrials.eu/trial/study-on-napabucasin-with-folfiri-for-adults-with-metastatic-colorectal-cancer-after-standard-treatments/
  2. https://clinicaltrials.gov/study/NCT02826161
  3. https://clinicaltrials.gov/study/NCT02753127
  4. https://clinicaltrials.gov/study/NCT02993731
  5. https://clinicaltrials.gov/study/NCT02358395
  6. https://clinicaltrials.gov/study/NCT02315534
  7. https://clinicaltrials.gov/study/NCT02851004
  8. https://clinicaltrials.gov/study/NCT03525405