Tag Archive for: phase iv

Breast Cancer Clinical Trials | What Are the Phases?

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Breast Cancer Clinical Trials | What Are the Phases? from Patient Empowerment Network on Vimeo.

What do breast cancer patients need to know about the phases of a clinical trial? Expert Dr. Jame Abraham explains the trial process and reviews what happens during each phase.

Dr. Jame Abraham is the chairman of the Department of Hematology & Medical Oncology at Cleveland Clinic and professor of medicine at Cleveland Clinic Lerner College of Medicine. Learn more about Dr. Abraham.

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Transcript:

Katherine:

Dr. Abraham, many people are confused about how breast cancer clinical trials are conducted. What are the phases of a clinical trial? 

Dr. Abraham:

So, that’s a really good question. It’s a really important question. And I’m kind of saying, there’s so many new things, and I’m talking about genomic testing, and I’m talking about all these new treatments. As I mentioned, I’ve been doing breast cancer for 20 years. So, every year, we are making huge progress in the treatment of breast cancer. Even then, more than 40,000 women will lose their life because of breast cancer. So, we have a long way to go. As you know, the only way we can make things better for tomorrow is by doing clinical trials. And there are so many different types of clinical trials. I’ll talk about that in a second. 

Every new treatment we have today is coming out through a clinical trial, and someone, somewhere, said yes to a new treatment, or will be part of a trial. And that’s the reason we have a new drug today, and that’s making things better for tomorrow. 

So, a clinical trial is extremely important, and I’ll say, a clinical trial is the gold standard of cancer treatment. And unfortunately, only less than seven percent of adults in the U.S. are enrolled in a clinical trial. Well, of course, that’s many reasons for that, but let me just make it clear. I know people sometimes worry, “Oh, by being part of a clinical trial, I’m a guinea pig.” No. No, no. Clinical trials are run with high ethical standards. So many committees review that, make sure it’s scientifically sound, it’s safe, and it protects the patient. 

So, there’s so many layers of protection for the patients before anyone enters in a clinical trial. 

So, there are treatment trials and non-treatment trials, and I’ll focus on – let me focus on treatment trials, not which other ones are making all these changes in the clinic. So, I’ve been doing trials for the last 20 years or so, or being part of a number of regional, and national, or global clients. 

So, there are three major types of trials. One, because Phase I, Phase I. That’s the earliest form of clinical trial, and we have some, what they call as, preclinical data. A drug is found to be promising, but we don’t have too much, if I can say, data, in patients, or humans. 

So, Phase I is the first human trial, which is looking for the right dose of the drug, what side effects we can expect, and we kind of look at how the drug is metabolized in the body. So, that’s the Phase I trial. 

The second one is Phase II, Phase II trial. Phase II trials are looking for efficacy, and how active this drug is in breast cancer. And the third type of trial is Phase III, Phase III. Phase III is what we call as, randomized trials. Means there’s a standard treatment, and now, we have this new drug. The question is, is the new drug better than the standard treatment? So, Phase III, it’s randomized. It’s divided into two groups. One group will get the standard treatment, and the second group will get this new treatment. 

And then, we’ll come back and compare these two, and see which is better. That’s Phase III. 

So, there is Phase IV, that’s, they call as, a post-marketing study, and once the – based upon the phase, early phase trials, the FDA can approve, or not approve, a drug. And let’s just say, if it’s approved, it’s in the market. Then, the patients can potentially go for a, what we call as, phase – I mean, potentially, we can do a Phase IV study. That’s post-marketing study. 

Understanding Prostate Cancer Clinical Trial Phases and Types

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Understanding Prostate Cancer Clinical Trial Phases and Types from Patient Empowerment Network on Vimeo.

How do prostate cancer clinical trials work? Dr. Sumit Subudhi shares what happens in each clinical trial phase and explains the function of open-label clinical trials, controlled clinical trials, randomized clinical trials, and double-blind randomized clinical trials.

Dr. Sumit Subudhi is an Associate Professor in the Department of Genitourinary Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. Learn more about Dr. Subudhi.

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Transcript:

Katherine:

I’d like to define some clinical trial terminology to help patients further understand the process. Let’s start with the phases. What occurs during each phase?   

Dr. Subudhi:

So, great question. Phase I is the safety phase. So, all we’re trying to do is find the right dose of the drug that is actually safe to give in the patients. And we’re looking for the maximum tolerated dose. And once we find that dose, then we use that dose to go to Phase II of the trial. And Phase II trials are looking at efficacy. So, looking to see whether the trial is giving you any clinical benefit, meaning the cancer’s shrinking or even disappearing. 

Katherine:

Go on. 

Dr. Subudhi:

And then the third phase is Phase III where you’re testing the current drug, experimental drug, to either standard of care or to a placebo to see whether or not you get a benefit, either a progression-free survival benefit or overall survival benefit. And so, those are the three phases of clinical trials.  

Katherine:

What are the different types of clinical trials? 

Dr. Subudhi:

So, they’re controlled trials. Actually, I should back up. So, there’s open-label trials where everyone that enrolls in the trial will get the experimental drug. So, there is no control arms in these trials. Then there is the control trials where you can either get the drug, or you may get a placebo or standard of care drug.  

There are some trials that allow for crossover, meaning that if you’re in the placebo or standard of care arm, if your cancer progresses, you can actually cross over and get the experimental drug. But I just want to be clear that not all clinical trials have crossover. And if you’re in a control trial, I think that’s an important question to ask your doctors about that. 

But the reason why we do the control trials is that we’ve learned that using historical controls – for example, we’re doing a lot of combination studies with chemotherapy, such as docetaxel (Taxotere), which was FDA-approved in 2004. So, if we’re using historical data from almost 20 years ago, it’s not the same thing as our patients that are being treated with docetaxel now, because their treatment landscape has changed so much, and our patients have changed so much. 

And so, for that reason, control trials give us a better sense of how effective this experimental drug is doing as opposed to comparing it to a historical perspective. 

Katherine:

What other types of clinical trials are available? 

Dr. Subudhi:

So, there are a few other options. So, we talked about open-label where everyone’s guaranteed to get the drug. We talked about a controlled study where you will either get one drug or another. And another type is a randomized trial where a computer decides whether or not you’re going to actually get one drug versus another. It’s not your doctor because a lot of people think that I’m making that decision, and I’m not. It’s actually a random computer. 

And some trials have 1:1 ratio, meaning a 50 percent chance that you’ll get the experimental drug versus the control drug. But other trials have 1:2 ratio or 1:3 ratio. So, that’s something that, again, you have to ask your physician of how these trials are being randomized. 

Katherine:

Well, in a randomized clinical trial, the patient isn’t going to know what drug they’re being given. 

Dr. Subudhi:

Actually, that’s not true. 

Katherine:

Oh, it’s not. 

Dr. Subudhi:

So, you bring up a great question. So, there’s a double-blind randomized clinical trial where not only the patient doesn’t know, but even the physicians and the nurses. No one except for the pharmaceutical company that’s running the trial actually knows who’s actually getting which drug. And it’s only towards the end of the trial that we unblind, and then we share that information. Well, the pharmaceutical company first shares it with the medical team who then shares it with the patient. 

Katherine:

Are there other common clinical trial terms that you think patients should know about and understand? 

Dr. Subudhi:

I think for now those are… 

Katherine:

…they’re the most important? 

Dr. Subudhi:

I think to me those are the most important. And I think that sometimes too much information can bog us down. 

Katherine:

Well, speaking of information, there is a lot out there, some of which may not be very reliable. And that could lead many patients to having misconceptions about clinical trials. Let’s walk through a few common concerns we’ve heard from our community about trials. 

One frequent question is – will I receive a placebo instead of a real treatment? And, first, I’d like you to define placebo. And should this be a concern for patients? 

Dr. Subudhi:

Right. So, placebo is a drug that looks similar to the experimental drug. For example, if the experimental drug is a blue pill, then the placebo will be a blue pill. But it will be a pill that should have no known biological activity.  

If the experimental drug is given intravenously and you get it in a liquid bag, then the placebo will also come in a liquid bag. So, it will look the same. And that’s why both the medical team as well as the patients or their families will not know which drug the patients have received, meaning the experimental drug or the placebo. But the placebos are meant to not have any biological activity. 

Katherine:

So, it shouldn’t be a concern to patients then.   

Dr. Subudhi:

Well, the concern that most of my patients share with me when they hear about placebo-controlled trials is, “Well, if I’m not going to get the experimental drug, why should I do this? I mean what benefit does it have for me?” And so, I tell them that one of the benefits is that we are watching you very carefully. 

Because we don’t know sometimes which drug you’re getting. But in some control trials, like a randomized control trial, we will know because I’m not blinded.  

If you’re in the arm that’s only getting chemotherapy, well, you know you’re not getting an oral pill. So, it’s very clear to the patient what they’re getting. But if they’re getting an oral pill that’s a placebo, we’re watching them very carefully.  

So, we’re watching the patients very carefully in these placebo-controlled trials. And they’re coming in often so that we’re not going to miss any devastating things happening from the cancer. In fact, we’ll pick it up earlier than if they were just getting a standard of care outside of a trial. And for that reason I tell that my patients, “Don’t be worried.” And I always make sure that I have a backup plan. 

So, the backup plan is either they’re going to cross over, meaning the trial allows for them to cross over to get the experimental drug. Or I have another trial that I know that they will qualify for. Or the third alternative is that I actually have a standard of care drug that I’m ready to give them the second I have it so that they don’t have to have those concerns. 

What Happens in Each Phase of a CLL Clinical Trial?

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What Happens in Each Phase of a CLL Clinical Trial? from Patient Empowerment Network on Vimeo.

What are the phases of clinical trials? CLL expert Dr. Michael Choi outlines the research purpose of clinical trials and what happens in each phase.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. More information on Dr. Choi here. 

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Transcript:

Laura Beth:

Dr. Choi, can you please walk us through the phases of a clinical trial and what happens during each phase?  

Dr. Choi:

That’s a great question. Yeah, historically, trials have been divided into different phases. The way I think of it is when a drug is first being tested, we don’t want to expose too many people to it, because we’re still learning about the right dose and about its safety. And then, as we learn more and more and maybe get some confirmation that it’s doing what it’s supposed to do, then we have bigger trials and eventually, bring in some comparisons to existing standards.  

So, a Phase I trial is usually, I would say, a few dozen patients, getting the drug for the very first time or sometimes for the first time for this diagnosis. Oftentimes, the very first Phase I trials might have a dose escalation component where the first dose or the first group of patients might get a dose that is based on an assurance that it will be – or some confidence that it will be safe and well-tolerated.  

Then, as the trial goes on, a higher dose will be used once we see that the previous doses are safe. Now, sometimes, this dose escalation happens in between different groups of patients, and sometimes, some trials will escalate the dose for even within an individual patient. But the basic idea of it is to start at doses that we think will be safe and then to gradually escalate it, again, prioritizing the safety of the patients.  

I shouldn’t also – although Phase I trials are designed to determine the safety of a drug, there are many Phase I trials that show clinical activity and benefit to the patients, so I don’t think people should be altogether discouraged from enrolling in a Phase I trial either. 

I can also say that some Phase I trials are just looking at a combination of drugs that we have experience with already, but designed or written as a Phase I trial, because we have to confirm the safety of those two drugs. In those trials, the doses might not be that different than what’s used already, and there’s often more expectation of immediate clinical benefit. Phase II trials are where we’re principally looking or usually looking mainly at the response rate or some sort of clinical endpoint, how many patients get into a partial remission, or how many patients get into a complete remission and so on.  

And I would say these are usually our trials that are 20, 30, 50 patients, to that effect. And basically, from that group of patients, we can get a pretty good estimate of how effective a drug or a drug combination may be. And then finally, the third type of trial, Phase III trial, is when a new drug or a new combination is compared directly to a different – to what would be considered the standard of care at the time.  

So, this is a way that we can get more confidence that this new drug is indeed better than what we’ve been doing up until now.  

CLL Clinical Trials: What Are the Phases?

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CLL Clinical Trials: What Are the Phases? from Patient Empowerment Network on Vimeo.

CLL clinical trials have different phases, but what happens in each phase? CLL expert Dr. Adam Kittai explains the goal of each phase in relation to research and patient care.

Dr. Adam Kittai is a hematologist and an assistant professor at the The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Kittai, here.

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Transcript:

Katherine:

Let’s talk a bit about how trials work, starting with the phases. What happens at each phase?  

Dr. Kittai:

There are actually four phases of clinical trials, although three phases are typically what’s talked about. So, Phase I is when we are first introducing the new medication, the combination, or the old medication in a new scenario for the first time in a human being.  

Phase one encompasses a lot of different things. It could be a first in-human phase one, where we’re giving the drug for the first time in a human being. It could be, as I said, the combination of drugs being used for the first time in a human being. Or it could be that we have this drug that works for this other cancer and we’re trying it out on this new cancer. So, we might have experience with this drug in another scenario, but not in the scenario we’re trying to do.  

And the primary purpose of the phase one clinical trial is to see if it’s safe. So, that’s the primary purpose of a phase one clinical trial – see if this new medication, this old medication in this new scenario, or this new combination is safe to use going forward.  

Katherine:

Right. 

Dr. Kittai:

We are able to see if it works to a small degree in the phase one trial, but typically these trials are very small with somewhere between 10 to 50 patients. And so, it’s hard to know how well this works by looking at such a small amount of patients.  

Once the Phase I trial goes forward, we usually go onto Phase II. So, one of the other points about Phase I is to determine the correct dose. Usually in phase ones, we increase the dose of the drug slowly until it meets some sort of toxicity cut-off for our patients. So, once that dose is discovered, then we move onto Phase II, and Phase II is usually a small study, usually about 50-100 patients where we’re looking at preliminary efficacy, to see if this drug, this new combination, or the drug in a new scenario, is actually working.   

And so, Phase II will tell us we think it’s working and if it looks good in phase two, it gets moved onto Phase III. Phase III is the final part of the drug development, where if it passes Phase III, it usually gets approved by the Federal Drug Administration. And Phase III is usually a randomized trial where you’re giving the new drug, the combo, or the old drug in a new situation, and you’re comparing it to whatever’s used as standard of care in that particular scenario.  

Katherine:

Right. 

Dr. Kittai:

And that’s usually a randomized study where patients are either getting the new thing or the old thing. And then, we’re determining which one works better. Lastly is Phase IV, and this is post marketing. So, after a drug gets approved, the drug company and the FDA requires just a wide scope of just data that’s collected to see how well the drug is working and if it’s safe once it’s brought out to the wider community.  

Trustworthy Resources to Help You Learn More About Lung Cancer

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Trustworthy Resources to Help You Learn More About Lung Cancer from Patient Empowerment Network on Vimeo.

Expert Dr. Martin Edelman shares credible resources to help lung cancer patients become informed and empowered.

Dr. Martin J. Edelman is Chair of the Department of Hematology/Oncology and Deputy Director for Clinical Research at Fox Chase Cancer Center. More about this expert here.

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Transcript:

Patricia:

Let’s talk a little bit about health literacy. What would you suggest patients use for online resources? What are good resources?

Dr. Edelman:

So, there are some excellent resources. The International Association for the Study of Lung Cancer has resources for patients. The National Coalition of Comprehensive Cancer Center Network (NCCN) has resources. American Society of Clinical Oncology has resources. So, those or American Cancer Society. So, there are some really reliable sources out there. And there’s a great deal that’s very unreliable – people’s Facebook pages. I’ve seen this.

Patricia:

It’s a big place.

Dr. Edelman:

Everybody always – and I think it’s important for people to understand. There will be people who will get something and have a fantastic response. I’ve used anecdotes.

The anecdotes I’ve used are to illustrate the potential hope of benefit. They’re not exceptions to the rule anymore. They’re the good case scenarios. I could have just as many anecdotes of people who didn’t benefit and stuff. And I think it is important going into this – and that’s why we are reassessing patients constantly and getting repeat scans because we don’t necessarily know always – even if something’s 90 percent effective, it means 10 percent of the time it’s not.

And each patient – we’re getting better at individualizing and personalizing therapy, but we’re not perfect yet. And we probably never will be. So, there will always be anecdotes. I think what’s – as a friend of mine puts it – the plural of anecdotes is not data. When I say, “Well, chemoimmunotherapy works.” It’s not because I have anecdotes of that, though anecdotes illustrate the magnitude of benefit.

I have data that shows that the chemoimmunotherapy regimen was compared to chemotherapy and was clearly and unequivocally superior. When I give a statistic that 60 percent of patients, 65 percent, can benefit from those types of regimens. That’s based upon prospective randomized control trials.