Related Experiment Video
Updated: May 12, 2026
06:20
Irradiator Commissioning and Dosimetry for Assessment of LQ α and β Parameters, Radiation Dosing Schema, and in vivo Dose Deposition
Published on: March 11, 2021
Phase I trial in oncology--theory and practice
R Demlova1, R Obermannova, D Valik
1Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Brno, Czech Republic.
Summary
Phase I oncology trials enroll patients with advanced cancer to determine safe new drug doses. The goal is to accelerate the development of novel anticancer therapies, improving patient survival and quality of life.
Area of Science:
- Oncology
- Clinical Pharmacology
- Drug Development
Background:
- Phase I trials are crucial for early-stage cancer drug development.
- These studies typically enroll patients with advanced cancer who have exhausted standard treatment options.
- Establishing safe and effective dosing is paramount for subsequent trial phases.
Purpose of the Study:
- To determine the recommended dosage and/or schedule for new anticancer drugs or combinations.
- To accelerate the development of novel cancer therapies.
- To improve the quality of life and survival rates for cancer patients.
Main Methods:
- Dose escalation studies are employed to identify the maximum tolerated dose.
- Patient enrollment focuses on individuals with advanced malignancies.
- The primary objective is to establish dosing for Phase II trials.
Main Results:
- Recommended doses and schedules are determined for further investigation.
- Data informs the progression of new anticancer agents into later-stage trials.
- The process aims to avoid exposing patients to ineffective low doses.
Conclusions:
- Phase I trials are essential for advancing oncology drug development.
- Successful completion enables the initiation of Phase II studies.
- The ultimate aim is to bring improved cancer treatments to patients faster.
More Related Videos
06:11Therapy Testing in a Spheroid-based 3D Cell Culture Model for Head and Neck Squamous Cell Carcinoma
Published on: April 20, 2018
07:40Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
Related Concept Videos
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:28Preclinical Development: Overview
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
02:49Cancer Therapies
Cancer therapies are various modes of treatment, such as surgery, radiation therapy, and chemotherapy that are administered to cancer patients.
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
However, cancer treatments can pose several challenges, as therapies used to kill cancer cells are generally also toxic to normal cells. Moreover, cancer cells mutate rapidly and can develop resistance to chemical agents or radiation therapy. Besides, all types of cancer cells may not respond to the same therapy. Some cancer cells respond to one...
02:57Targeted Cancer Therapies
The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...
There are several types of targeted therapies against specific...
01:21Cancer Survival Analysis
Cancer survival analysis focuses on quantifying and interpreting the time from a key starting point, such as diagnosis or the initiation of treatment, to a specific endpoint, such as remission or death. This analysis provides critical insights into treatment effectiveness and factors that influence patient outcomes, helping to shape clinical decisions and guide prognostic evaluations. A cornerstone of oncology research, survival analysis tackles the challenges of skewed, non-normally...