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Phase I Clinical Trials

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by

Cathy Sze

on 30 January 2014

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Transcript of Phase I Clinical Trials

The tip of the iceberg.
Phase I Clinical Trials
Let's break it down.
Drugs may also be administered in different ways, such as by regional therapy

Who should we test?
The People
Among the group of 20-80 people, a phase I clinical trial will consist of a diverse range of participants
The individuals can be healthy, can have the disease wanting to be treated or fall anywhere in between
Limitations?
C-a-n-c-e-r
Example of disease
Patients in Phase I trials are sometimes the first to try new cancer drugs
Most have advanced cancer that has not responded to standard cancer treatments
One in five drugs will prove safe and effective enough to receive approval
Some of drugs end up being most effective for patients with different diseases than those that they were originally created to treat
The guinea pig stage.
What exactly is a Phase I Clinical Trial?
Definition:
A phase I clinical trial is an intervention tested in a small (20-80) group of people to evaluate its safety, identify side effects, and determine a safe dosage range.

It takes approximately 10 years of study in test tubes and laboratory mice to reach the point where a treatment may be tested for its safety and effectiveness in humans.
Thanks & Let's discuss
First stage of clinical testing
Often involve drugs that have been tested extensively in the laboratory and on animals with encouraging results
Have not yet been given to humans
What phase?
Cohorts Within Phase I
Trial participants are divided into small groups, known as cohorts
The first cohort receives a low dose of the new drug
Doctors may collect blood or urine samples to measure drug levels in the patients
Next cohort
If the first cohort does not have any severe side effects, then a new cohort receives a higher dose of the same drug
...and the next cohort
The dose increases until the trial investigators find the best dose for future testing
With each increasing dose, doctors test each patient to see if he or she is responding to the treatment
Safe or not safe?
Doctors decide!
Most of the time clinical trials last 42% longer than expected in Phase I
Safe
If the doctors find that the treatment is safe, then it will advance to a Phase II trial
What else?
Many trials require frequent return visits to the Clinical Center for Targeted Therapy, for safety monitoring
Some Phase I trials test new uses for drugs that have already been approved by the Food and Drug Administration, or test drugs given for the first time in combination.
Some trials may be performed in collaboration with the National Cancer Institute (NCI)
Summary of a
Phase I Clinical Trial

Let's look into one case.
Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study
Summary
Phase I clinical trials are very important in clinical studies - at present over 840 in the US
Bench-to-bedside (Translational Phase I) is much slower than its corresponding Phase I Clinical Trial
New drug applications and supplemental new drug applications for more than 200 drugs are still awaiting approval
Diseases such as ALK-driven childhood cancer are being tested everyday. There about 400 new cancer therapies in preclinical and clinical development
Crizotinib = is an anti-cancer drug acting as an ALK (anaplastic lymphoma kinase) inhibitor, approved for treatment of some lung carcinoma in the US, and undergoing clinical trials testing its safety and efficacy in advanced solid tumors in both adults and children

ALK-positive patients received oral crizotinib 250 mg twice daily in 28-day cycles. Endpoints included tumour responses and overall survival at 6 and 12 months

Determination was made of the safety, tolerability and characterization of the plasma pharmacokinetic profile of crizotinib after administration

Responses were analyzed in evaluable patients and safety were analyzed in all patients
Findings of ALK study
The response rate seemed to be largely independent of age, sex, performance status, or line of treatment

34 patients continued to receive crizotinib for more than two weeks after progression because of perceived ongoing clinical benefit from the drug

Common adverse side effects were visual effects, nausea, diarrhea, constipation, and vomiting
Figure 1.
Water fall plot of best percent change in target lesions from baseline for 133* patients on the basis of investigator assessment
What now?
On the basis of data from this study and preliminary data from a phase II study, 45 accelerated approval for crizotinib has been granted by the US Food and Drug Administration (USFDA)
Crizotinib is also being tested in clinical trials of advanced lymphoma and neuroblastoma
"Crizotinib caused tumors to shrink or stabilize in 90% of 82 patients carrying the ALK fusion gene"
Group of individuals chosen
Approximately 70% of new medical treatments pass Phase I testing stage
Definition
Example
Evaluation Process
Summary of case study
Discussion
Cathy Sze
January 30, 2014

Q: What percentage of Phase I Clinical Trials are approved?
(a) 20%
(b) 50%
(c) 70%
(d) 90%
The Diseases
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