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N-[4-Bromo-2-(1H-1,2,3,4-Tetrazol-5-Yl)Phenyl]-N’-[3,5- Bis(Trifluoromethyl)Phenyl]Urea

This article discusses the clinical trials of SCO-101, a drug containing N-[4-Bromo-2-(1H-1,2,3,4-Tetrazol-5-Yl)Phenyl]-N’-[3,5- Bis(Trifluoromethyl)Phenyl]Urea, in combination with FOLFIRI for treating metastatic colorectal cancer (mCRC). The trials aim to evaluate the safety, tolerability, and effectiveness of this combination therapy in patients who have developed resistance to standard FOLFIRI treatment.

Table of Contents

Introduction to SCO-101

SCO-101, also known as N-[4-BROMO-2-(1H-1,2,3,4-TETRAZOL-5-YL)PHENYL]-N’-[3,5- BIS(TRIFLUOROMETHYL)PHENYL]UREA, is a promising new drug being developed for the treatment of metastatic colorectal cancer (mCRC). This medication is currently being studied in patients whose cancer has become resistant to standard treatments[1].

How SCO-101 Works

SCO-101 is classified as a chloride channel inhibitor. While the exact mechanism is not fully explained in the provided information, chloride channel inhibitors generally work by blocking certain channels in cancer cells, which can interfere with their growth and survival[1]. This unique approach may help overcome resistance to other treatments.

Current Clinical Trial

A phase II clinical trial is currently underway to investigate SCO-101 in combination with a chemotherapy regimen called FOLFIRI. This trial aims to determine:[1]

  • The safety and side effects of SCO-101 when used with FOLFIRI
  • The most effective and safe dose of SCO-101
  • How well the combination works in treating metastatic colorectal cancer

The trial is divided into three stages, each focusing on different aspects of the treatment and different patient groups[1].

Who Can Participate in the Trial?

The trial is designed for patients with metastatic colorectal cancer who have specific characteristics. Some key eligibility criteria include:[1]

  • Age 18 years or older
  • Confirmed diagnosis of metastatic colorectal cancer
  • Previous treatment with certain chemotherapy drugs (irinotecan and 5-FU) that is no longer working
  • Good overall health status

It’s important to note that there are many other specific criteria that doctors use to determine if a patient is eligible for the trial. These criteria help ensure the safety of participants and the reliability of the study results[1].

Safety and Side Effects

As with any new treatment, understanding the safety profile of SCO-101 is a crucial part of the clinical trial. The researchers will be closely monitoring participants for any side effects or adverse reactions. Some potential areas of concern that will be watched include:[1]

  • Changes in blood cell counts
  • Liver function
  • Kidney function
  • Cardiovascular health

It’s important to remember that all medical treatments can have side effects, and the purpose of this trial is to better understand both the benefits and risks of SCO-101[1].

Potential Benefits of SCO-101

While it’s too early to know for certain, the researchers hope that SCO-101, when combined with FOLFIRI chemotherapy, may offer several potential benefits for patients with metastatic colorectal cancer:[1]

  • Improved response to treatment: The trial will measure how many patients experience tumor shrinkage (called “objective response rate”)
  • Longer-lasting benefits: Researchers will look at how long the treatment keeps working before the cancer starts growing again
  • Extended survival: The study will track how long patients live after starting the treatment
  • Overcoming drug resistance: SCO-101 may help make chemotherapy effective again in patients whose cancer has become resistant to standard treatments

It’s important to note that these are potential benefits that the trial aims to investigate. The actual effectiveness of SCO-101 will only be known after the trial is completed and the results are analyzed[1].

Aspect Details
Study Type Phase II open-label clinical trial
Drug Studied SCO-101 (N-[4-Bromo-2-(1H-1,2,3,4-Tetrazol-5-Yl)Phenyl]-N’-[3,5- Bis(Trifluoromethyl)Phenyl]Urea) in combination with FOLFIRI
Target Condition Metastatic Colorectal Cancer (mCRC) resistant to FOLFIRI
Main Objectives Determine safety, toxicity profile, maximum tolerated dose, and objective response rate
Key Eligibility Criteria Adults with mCRC, previous FOLFIRI treatment, disease progression on standard treatments
Primary Endpoints Safety, tolerability, maximum tolerated dose, objective response rate
Secondary Endpoints Progression-free survival, duration of response, overall survival, pharmacokinetics, biomarker evaluation

FAQ

  • What is SCO-101 and how is it being studied? SCO-101 is a drug containing N-[4-Bromo-2-(1H-1,2,3,4-Tetrazol-5-Yl)Phenyl]-N'-[3,5- Bis(Trifluoromethyl)Phenyl]Urea. It is being studied in combination with FOLFIRI chemotherapy for treating metastatic colorectal cancer in patients who have developed resistance to standard FOLFIRI treatment.
  • What are the main objectives of the clinical trial? The main objectives are to determine the safety and toxicity profile of SCO-101 with FOLFIRI, find the maximum tolerated dose, and assess the objective response rate in patients after 20 weeks of treatment.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) with histologically verified metastatic colorectal cancer who have progressed on all available standard treatments or are intolerant to them. They must have previously received and shown progressive disease with irinotecan and 5-FU based chemotherapy.
  • What are some of the exclusion criteria for the trial? Some exclusion criteria include concurrent chemotherapy or radiotherapy, severe medical conditions, known hypersensitivity to the study drugs, pregnancy or breastfeeding, and certain cardiovascular conditions within the past 6 months.
  • How will the effectiveness of the treatment be measured? The effectiveness will be measured through various endpoints, including progression-free survival, duration of response, overall survival, and objective response rate according to RECIST criteria. The study will also evaluate biomarkers and conduct pharmacokinetic analyses.

Ongoing Clinical Trials on N-[4-Bromo-2-(1H-1,2,3,4-Tetrazol-5-Yl)Phenyl]-N’-[3,5- Bis(Trifluoromethyl)Phenyl]Urea

  • Study of SCO-101 with FOLFIRI for Patients with Metastatic Colorectal Cancer Resistant to FOLFIRI

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Metastatic Colorectal Cancer (mCRC): Cancer that has spread from the colon or rectum to other parts of the body.
  • FOLFIRI: A chemotherapy regimen that combines the drugs FOLinic acid (leucovorin), Fluorouracil (5-FU), and IRInotecan.
  • SCO-101: An investigational drug containing N-[4-Bromo-2-(1H-1,2,3,4-Tetrazol-5-Yl)Phenyl]-N'-[3,5- Bis(Trifluoromethyl)Phenyl]Urea, being studied in combination with FOLFIRI for treating metastatic colorectal cancer.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • Progression Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Clinical Benefit Rate (CBR): The percentage of patients whose cancer shrinks or remains stable for a minimum period of time.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Biomarker: A measurable indicator of a biological condition or state, used to predict or monitor disease progression or treatment response.
  • UGT1A1: An enzyme involved in the metabolism of certain drugs, including irinotecan. Variations in the UGT1A1 gene can affect how a person responds to treatment.

References

  1. http://clinicaltrials.eu/trial/study-of-sco-101-with-folfiri-for-patients-with-metastatic-colorectal-cancer-resistant-to-folfiri/