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Sodium Trans-[Tetrachlorobis(1H-Indazole)Ruthenate(Iii) Dihydrate

This article discusses an ongoing clinical trial investigating the use of BOLD-100 (Sodium Trans-[Tetrachlorobis(1H-Indazole)Ruthenate(III) Dihydrate) in combination with FOLFOX chemotherapy for patients with advanced solid tumors. The study aims to assess the safety, tolerability, and effectiveness of this combination therapy in treating various types of cancer, including colorectal, pancreatic, and gastric cancers.

Table of Contents

What is BOLD-100?

BOLD-100 is an investigational drug being studied for the treatment of advanced solid tumors[1]. Its active ingredient is a chemical compound called sodium trans-[tetrachlorobis(1H-indazole)ruthenate(III) dihydrate. This complex name refers to the drug’s chemical structure, which contains the metal ruthenium along with other elements[1].

BOLD-100 is also known by several other names, including:

  • NKP-1339 dihydrate
  • KP-1339 dihydrate
  • IT-139 dihydrate

These alternative names may be used in scientific literature or discussions about the drug[1].

Medical Conditions Treated

BOLD-100 is being investigated for the treatment of several types of advanced solid tumors, including[1]:

  • Colorectal Cancer: Cancer that starts in the colon or rectum
  • Advanced Solid Gastrointestinal Tumors: Cancers that affect the digestive system
  • Pancreatic Cancer: Cancer that begins in the pancreas
  • Cholangiocarcinoma: A type of cancer that forms in the bile ducts

These conditions are all considered advanced solid tumors, meaning they are cancers that form solid masses and have progressed to later stages[1].

How BOLD-100 Works

While the exact mechanism of action is not fully described in the provided information, BOLD-100 is being studied in combination with a standard chemotherapy regimen called FOLFOX[1]. FOLFOX is a combination of drugs commonly used to treat various types of cancer, especially colorectal cancer.

The goal of combining BOLD-100 with FOLFOX is to potentially enhance the effectiveness of treatment for patients with advanced solid tumors[1].

Clinical Trial Information

BOLD-100 is currently being studied in a clinical trial called “A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination with FOLFOX Chemotherapy in Patients with Advanced Solid Tumours”[1]. This trial has two main parts:

  1. Part A (Dose Escalation): This part aims to assess the safety, tolerability, and determine the Maximum Tolerated Dose (MTD) of BOLD-100 when combined with FOLFOX chemotherapy[1].
  2. Part B (Dose Expansion): This part will evaluate how well patients respond to the combination of BOLD-100 and FOLFOX chemotherapy[1].

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria. Some key eligibility requirements include[1]:

  • Being 18 years or older
  • Having a confirmed diagnosis of one of the specified advanced solid tumors
  • Having received at least one prior line of chemotherapy (for most cancer types)
  • Having measurable disease according to specific criteria (RECIST v1.1)
  • Being in relatively good overall health, with an ECOG performance score of 0 or 1

There are also several exclusion criteria, such as certain medical conditions or prior treatments that would prevent a patient from participating in the trial[1].

Potential Side Effects

As BOLD-100 is still being studied, all potential side effects may not be known. The clinical trial is designed to monitor for adverse events (side effects) closely. Some areas being watched include[1]:

  • Changes in blood tests (chemistry, hematology, coagulation)
  • Changes in heart rhythm (monitored by electrocardiograms)
  • Changes in vital signs
  • Changes in overall physical condition

The severity of side effects will be graded according to standardized criteria (NCI CTCAE Version 5.0)[1].

Important Considerations

If you’re considering participating in this clinical trial or learning more about BOLD-100, keep in mind:

  • BOLD-100 is an investigational drug, meaning it’s not yet approved for general use[1].
  • The trial combines BOLD-100 with standard chemotherapy (FOLFOX), so participants will receive both treatments[1].
  • Participation in clinical trials is voluntary and requires informed consent[1].
  • The trial has specific eligibility criteria, and not all patients with the specified cancers will qualify[1].

Always consult with your healthcare provider to determine if participating in a clinical trial is appropriate for your specific situation.

Aspect Details
Study Type Phase 1b/2a Dose Escalation Study
Treatment BOLD-100 in combination with FOLFOX chemotherapy
Target Conditions Advanced solid tumors, including colorectal, pancreatic, gastric, and other gastrointestinal cancers
Primary Objectives Assess safety, tolerability, maximum tolerated dose, and response rates
Key Eligibility Criteria Adults 18+, confirmed advanced solid tumors, prior treatment (except gastric cancer), measurable disease, ECOG score 0-1
Main Exclusion Criteria Severe neuropathy, recent weight loss, HIV-positive status, pregnancy, serious medical conditions
Primary Endpoints Adverse events, serious adverse events, dose-limiting toxicities, changes in lab values and clinical assessments

FAQ

  • What is BOLD-100? BOLD-100 is an investigational drug containing Sodium Trans-[Tetrachlorobis(1H-Indazole)Ruthenate(III) Dihydrate. It is being studied in combination with standard chemotherapy (FOLFOX) for the treatment of advanced solid tumors.
  • What types of cancer does this clinical trial focus on? The trial focuses on advanced solid tumors, particularly gastrointestinal cancers such as colorectal cancer, pancreatic cancer, gastric cancer, and cholangiocarcinoma (bile duct cancer).
  • What are the main objectives of the study? The main objectives are to assess the safety and tolerability of BOLD-100 in combination with FOLFOX chemotherapy, determine the maximum tolerated dose, and evaluate the response rates in patients with advanced solid tumors.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) with confirmed advanced solid tumors, who have received at least one prior line of therapy (except for gastric cancer patients). They must have measurable disease, adequate organ function, and an ECOG performance score of 0 or 1.
  • Are there any specific exclusion criteria for the trial? Yes, some exclusion criteria include neuropathy greater than grade 2, recent weight loss of more than 10%, HIV-positive status, pregnancy or breastfeeding, and certain serious medical conditions such as uncontrolled psychiatric disorders or recent cardiac events.

Ongoing Clinical Trials on Sodium Trans-[Tetrachlorobis(1H-Indazole)Ruthenate(Iii) Dihydrate

  • Study of BOLD-100 with FOLFOX chemotherapy (fluorouracil, folinic acid, and oxaliplatin) in patients with advanced gastrointestinal tumors, colorectal, gastric, or pancreatic cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Ireland Italy Spain

Glossary

  • BOLD-100: An investigational drug containing Sodium Trans-[Tetrachlorobis(1H-Indazole)Ruthenate(III) Dihydrate, being studied for the treatment of advanced solid tumors.
  • FOLFOX: A standard chemotherapy regimen used to treat various types of cancer, particularly colorectal cancer. It combines the drugs FOLinic acid (leucovorin), Fluorouracil (5-FU), and OXaliplatin.
  • Advanced Solid Tumors: Cancers that have spread from where they started to other parts of the body and are usually not curable with current treatments.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Unresectable: A tumor that cannot be removed completely through surgery.
  • RECIST: Response Evaluation Criteria In Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • ECOG Performance Score: A scale used to assess how a patient's disease affects their daily living abilities and determine appropriate treatment and prognosis.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose reduction.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.
  • Cholangiocarcinoma: A type of cancer that forms in the bile ducts, which are tubes that connect the liver, gallbladder, and small intestine.

References

  1. http://clinicaltrials.eu/trial/study-of-bold-100-with-folfox-for-patients-with-advanced-colorectal-pancreatic-gastric-and-other-solid-tumors/