#1 Clinical Trials Search in Europe

Trilaciclib Dihydrochloride Dihydrate

This article explores the use of Trilaciclib Dihydrochloride Dihydrate in clinical trials for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The drug is being studied in combination with topotecan chemotherapy to assess its potential benefits in improving overall survival and reducing chemotherapy-induced side effects. The trial aims to evaluate the drug’s effectiveness, safety, and impact on various aspects of patient care during cancer treatment.

Table of Contents

What is Trilaciclib?

Trilaciclib Dihydrochloride Dihydrate, also known by its product code G1T28-1, is a medication being studied for the treatment of Extensive Stage Small Cell Lung Cancer (ES-SCLC)[1]. It is administered through an intravenous infusion, which means it is given directly into a vein.

Medical Condition: Extensive Stage Small Cell Lung Cancer

Extensive Stage Small Cell Lung Cancer (ES-SCLC) is an advanced form of lung cancer that has spread beyond the lungs to other parts of the body[1]. This type of cancer is known for its aggressive nature and often requires intensive treatment.

How Trilaciclib Works

Trilaciclib is designed to be given before chemotherapy treatment. Its main purpose is to help protect the bone marrow and immune system from the harmful effects of chemotherapy[1]. By doing this, it aims to reduce some of the side effects associated with cancer treatment, such as:

  • Neutropenia: A decrease in white blood cells, which can increase the risk of infections
  • Anemia: A decrease in red blood cells, which can cause fatigue and weakness
  • Thrombocytopenia: A decrease in platelets, which can lead to easy bruising and bleeding

Clinical Trial Details

A clinical trial is currently being conducted to evaluate the effectiveness of Trilaciclib in patients with ES-SCLC[1]. Here are some key points about the study:

  • It is a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either Trilaciclib or a placebo, and neither the patients nor the doctors know which one they’re receiving during the study.
  • The study aims to determine if Trilaciclib can improve overall survival in patients receiving a chemotherapy drug called topotecan.
  • The researchers will also look at other factors such as how long the cancer stays under control (progression-free survival) and how well patients respond to the treatment (objective response rate).

Eligibility Criteria

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

  • Having a confirmed diagnosis of ES-SCLC
  • Having cancer that has progressed during or after previous chemotherapy
  • Being in overall good health, with adequate organ function
  • Not having received previous treatment with topotecan or Trilaciclib

There are also several conditions that would exclude a patient from participating, such as having certain other medical conditions or having received specific treatments recently.

Potential Benefits of Trilaciclib

The researchers hope that Trilaciclib will provide several benefits to patients with ES-SCLC[1]:

  • Improved overall survival
  • Reduced side effects from chemotherapy, particularly those affecting blood cells
  • Fewer hospitalizations due to chemotherapy-induced side effects
  • Potentially allowing patients to receive their full planned chemotherapy doses without delays or reductions

Safety Considerations

As with any medical treatment, safety is a crucial concern. The clinical trial will closely monitor patients for any side effects or adverse events[1]. Some specific safety measures include:

  • Regular monitoring of blood cell counts
  • Watching for signs of infection or fever
  • Monitoring for any allergic reactions to the medication
  • Checking for any effects on heart function

It’s important to note that while Trilaciclib shows promise, it is still being studied, and more research is needed to fully understand its effects and potential benefits for patients with ES-SCLC.

Aspect Details
Study Type Randomized, Double-Blind, Placebo-Controlled
Primary Objective Evaluate non-inferiority of trilaciclib vs placebo in overall survival
Patient Population Adults with Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Treatment Trilaciclib or placebo administered before topotecan chemotherapy
Key Endpoints Overall survival, progression-free survival, objective response rate, myelosuppression-related outcomes
Safety Assessments Adverse events, laboratory abnormalities, treatment discontinuations
Dosing Maximum daily dose: 240 mg/m², Maximum total dose: 1200 mg/m²
Treatment Duration Up to 120 days

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate whether trilaciclib administered before topotecan chemotherapy is non-inferior to placebo in terms of overall survival for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
  • Who is eligible to participate in this trial? Eligible participants include adults with ES-SCLC who have progressed during or after prior first- or second-line chemotherapy, have measurable or evaluable disease, and are considered suitable for topotecan chemotherapy. They must also have adequate organ function and meet other specific criteria outlined in the study protocol.
  • What are some of the secondary objectives of the trial? Secondary objectives include assessing the effects of trilaciclib on anti-tumor endpoints (such as progression-free survival and objective response rate), evaluating its impact on blood cell lineages (neutrophils, red blood cells, and platelets), and examining its effects on hospitalizations due to chemotherapy-induced myelosuppression.
  • How is the drug administered in this trial? Trilaciclib Dihydrochloride Dihydrate is administered as an intravenous infusion before topotecan chemotherapy. The maximum daily dose is 240 mg/m², with a maximum total dose of 1200 mg/m² over a treatment period of up to 120 days.
  • What are some of the exclusion criteria for this trial? Some exclusion criteria include a history of topotecan or trilaciclib treatment for SCLC, presence of untreated brain metastases, history of interstitial lung disease or pneumonitis, significant cardiovascular disease, and active serious infections such as HIV, Hepatitis B, or Hepatitis C.

Ongoing Clinical Trials on Trilaciclib Dihydrochloride Dihydrate

  • Study on Trilaciclib and Topotecan for Patients with Extensive Stage Small Cell Lung Cancer

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Germany Greece Hungary +2

Glossary

  • Extensive Stage Small Cell Lung Cancer (ES-SCLC): A type of lung cancer that has spread beyond the lung where it started and to other parts of the body. It is characterized by rapid growth and spread.
  • Trilaciclib Dihydrochloride Dihydrate: The investigational drug being studied in this trial, designed to be administered before chemotherapy to potentially improve treatment outcomes and reduce side effects.
  • Topotecan: A chemotherapy drug used to treat certain types of cancer, including small cell lung cancer. It belongs to a class of drugs called topoisomerase inhibitors.
  • Overall Survival (OS): The length of time from the start of treatment (or diagnosis) that patients are still alive.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with the disease without it getting worse.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Myelosuppression: A condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to measure how well a cancer patient responds to treatment.
  • ECOG Performance Status: A scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Neutropenia: An abnormally low count of neutrophils, a type of white blood cell important for fighting infections.

References

  1. http://clinicaltrials.eu/trial/study-on-trilaciclib-and-topotecan-for-patients-with-extensive-stage-small-cell-lung-cancer/