#1 Clinical Trials Search in Europe

Tipiracil Hydrochloride

Tipiracil Hydrochloride, often used in combination with other drugs, is being studied in various clinical trials for its potential in treating different types of cancer, particularly colorectal cancer. These trials aim to evaluate the drug’s effectiveness, safety, and potential benefits when combined with other treatments. The research spans different stages of cancer and explores various drug combinations to find the most effective treatment options for patients.

Table of Contents

What is Tipiracil Hydrochloride?

Tipiracil Hydrochloride is a medication used in cancer treatment, often in combination with another drug called Trifluridine. This combination is known by several names, including:

  • TAS-102
  • Lonsurf
  • Trifluridine/Tipiracil
  • Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
Tipiracil Hydrochloride belongs to a class of medications called thymidine phosphorylase inhibitors. Its main role is to slow down the breakdown of Trifluridine in the body, allowing it to work more effectively against cancer cells[1].

What Conditions Does Tipiracil Hydrochloride Treat?

Tipiracil Hydrochloride, in combination with Trifluridine, is primarily used to treat:

  • Metastatic Colorectal Cancer: This is cancer of the colon or rectum that has spread to other parts of the body[2].
  • Advanced Gastric Cancer: This refers to stomach cancer that is in an advanced stage[3].
  • Metastatic Gastroesophageal Junction Adenocarcinoma: This is cancer that occurs where the esophagus (food pipe) meets the stomach and has spread to other parts of the body[3].
It’s typically used when other treatments have not been effective or have stopped working[2].

How Does Tipiracil Hydrochloride Work?

Tipiracil Hydrochloride works in conjunction with Trifluridine to fight cancer cells:

  1. Trifluridine is a type of drug called a thymidine-based nucleoside analogue. It works by interfering with the DNA of cancer cells, stopping them from growing and dividing[1].
  2. Tipiracil Hydrochloride helps to keep Trifluridine active in the body for longer. It does this by blocking an enzyme that would normally break down Trifluridine[1].
By working together, these two drugs can effectively slow down or stop the growth of cancer cells[1].

Combination Therapy with Tipiracil Hydrochloride

Tipiracil Hydrochloride is often used in combination with other cancer treatments to enhance its effectiveness. Some common combinations include:

  • TAS-102 (Trifluridine/Tipiracil) with Oxaliplatin: This combination is being studied for treating various gastrointestinal cancers, including colorectal and esophageal cancers[3].
  • TAS-102 with Irinotecan and Bevacizumab: This triple combination is being investigated for treating metastatic colorectal cancer[4].
  • TAS-102 with Nanoliposomal Irinotecan: This combination is being studied for advanced gastrointestinal cancers[5].
  • TAS-102 with Panitumumab or Bevacizumab: These combinations are being compared for first-line treatment of metastatic colorectal cancer[6].
These combinations aim to improve the effectiveness of cancer treatment and potentially overcome resistance to single-drug therapies.

Current Clinical Trials

Several clinical trials are currently underway to further investigate the effectiveness of Tipiracil Hydrochloride in various combinations and for different types of cancer:

  • A study comparing TAS-102 plus Panitumumab versus TAS-102 plus Bevacizumab for first-line treatment of metastatic colorectal cancer[6].
  • A trial investigating TAS-102 in combination with Oxaliplatin for treating resectable esophageal or gastroesophageal junction adenocarcinoma[3].
  • A study of TAS-102 combined with Nanoliposomal Irinotecan for advanced gastrointestinal cancers[5].
  • A trial examining TAS-102 in combination with Irinotecan and Bevacizumab for pre-treated metastatic colorectal cancer[4].
These trials aim to expand our understanding of how Tipiracil Hydrochloride can be most effectively used in cancer treatment.

Potential Side Effects

Like all medications, Tipiracil Hydrochloride can cause side effects. Common side effects may include:

  • Decreased blood cell counts (which can lead to increased risk of infection, anemia, or bleeding)
  • Nausea and vomiting
  • Fatigue
  • Diarrhea
  • Loss of appetite
The severity and frequency of side effects can vary depending on the individual and the specific treatment regimen. Your healthcare team will monitor you closely for any adverse effects during treatment[2][7].

How is Tipiracil Hydrochloride Administered?

Tipiracil Hydrochloride, as part of TAS-102, is typically administered orally (by mouth) in the form of tablets. The usual dosing schedule is:

  • Taken twice daily on days 1-5 and 8-12 of a 28-day cycle[6].
  • The dose is usually based on body surface area, often around 35 mg/m² twice daily[6].
However, the exact dosing and schedule can vary depending on the specific treatment plan and combination of drugs being used. Always follow your healthcare provider’s instructions precisely when taking this medication.

Aspect Details
Primary Cancer Types Colorectal cancer, gastroesophageal junction adenocarcinoma, biliary tract cancers
Common Drug Combinations Tipiracil Hydrochloride with oxaliplatin, irinotecan, bevacizumab, trastuzumab
Administration Method Oral, typically twice daily on specific days within a treatment cycle
Key Outcome Measures Progression-free survival, overall survival, response rate, safety profile
Trial Phases Primarily Phase I and II studies
Patient Populations Often focusing on metastatic or advanced stage cancers
Monitoring Aspects Adverse events, tumor response, quality of life, biomarkers

FAQ

  • What types of cancer are being studied with Tipiracil Hydrochloride? Tipiracil Hydrochloride is being studied primarily for colorectal cancer, but trials also include gastroesophageal junction adenocarcinoma, biliary tract cancers, and other advanced gastrointestinal cancers.
  • How is Tipiracil Hydrochloride typically administered? Tipiracil Hydrochloride is usually given orally (by mouth) in combination with other drugs. It's often taken twice daily on specific days within a treatment cycle.
  • What are some common drug combinations being tested with Tipiracil Hydrochloride? Common combinations include Tipiracil Hydrochloride with drugs like oxaliplatin, irinotecan, bevacizumab, and trastuzumab. These combinations are being tested to see if they improve treatment outcomes.
  • What are the main goals of these clinical trials? The main goals include assessing the drug's effectiveness in slowing cancer progression, improving survival rates, determining the best dosage, evaluating side effects, and understanding how it works in combination with other treatments.
  • Are there any notable side effects being monitored in these trials? While specific side effects vary, researchers are closely monitoring for adverse events related to the treatment combinations. Common areas of focus include digestive issues, blood cell count changes, and overall patient tolerability of the treatments.

Ongoing Clinical Trials on Tipiracil Hydrochloride

  • Study of Bemarituzumab with Irinotecan, Paclitaxel, Ramucirumab, or Trifluridine/Tipiracil for Advanced Stomach or Gastroesophageal Cancer in Patients After Chemotherapy

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Germany Spain

  • A Study Comparing Telisotuzumab Adizutecan to Trifluridine, Tipiracil, and Bevacizumab in Adults with Refractory Metastatic Colorectal Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland Spain

  • Study on the Effectiveness and Safety of AZD0901 Compared to Standard Treatments for Adults with Advanced Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2

    Not recruiting

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

  • Study on the Safety and Effectiveness of Trifluridine/Tipiracil, Capecitabine, and Bevacizumab for Patients with Metastatic Colorectal Cancer Unfit for Intensive Chemotherapy

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study Comparing Sotorasib and Panitumumab with Other Drug Combinations for Patients with Metastatic Colorectal Cancer and KRAS p.G12C Mutation

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France Germany Greece Italy Spain

  • Study of Trifluridine and Tipiracil in Patients with ER-Positive, HER2-Negative Advanced Breast Cancer After Chemotherapy

    Not recruiting

    1 1 1
    Investigated drugs:
    The Netherlands

  • Study Comparing Relatlimab-Nivolumab Combination with Regorafenib or Trifluridine-Tipiracil for Patients with Advanced Metastatic Colorectal Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +4

  • Study on the Safety and Effectiveness of REGN7075 and Cemiplimab, with or without Chemotherapy, for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1
    Investigated drugs:
    France The Netherlands Poland Spain

  • Study comparing trifluridine/tipiracil with bevacizumab versus capecitabine with bevacizumab as first-line treatment for patients with metastatic colorectal cancer who cannot receive intensive therapy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Poland Slovakia Sweden

Glossary

  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • 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.
  • Response rate: The percentage of patients whose cancer shrinks or disappears after treatment.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • RECIST: 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.
  • Intravenous (IV): Administered directly into a vein.
  • Orally (PO): Taken by mouth.
  • Circulating tumor DNA (ctDNA): Fragments of DNA from cancer cells found in the bloodstream.

References

  1. https://clinicaltrials.gov/study/NCT05356897
  2. https://clinicaltrials.gov/study/NCT03306394
  3. https://clinicaltrials.gov/study/NCT04097028
  4. https://clinicaltrials.gov/study/NCT04109924
  5. https://clinicaltrials.gov/study/NCT03368963
  6. https://clinicaltrials.eu/trial/study-comparing-trifluridine-tipiracil-with-panitumumab-or-bevacizumab-for-patients-with-metastatic-colorectal-cancer/
  7. https://clinicaltrials.gov/study/NCT04294264