Phase I trials Archives

Transcript:

Lisa:

Dr. Gong, can you speak to any early phase trials that have shown encouraging results for stomach or gastric cancer and in particular any of those related to metastatic disease?

Dr. Jun Gong:

So the exciting part about research in stomach or gastric cancer is that there are a lot of ongoing exciting developments in new treatment diagnostics almost every year. And so I think in terms of advanced or metastatic stomach cancer, some of the more exciting trials that have been ongoing and for which results are eagerly anticipated include novel targeted therapies. Here beyond HER2, MSI, EBV PD-L1. We’re looking at novel targets such as claudin. In fact, it is highly anticipated that the first claudin antibody will be available soon for all corners in the U.S. with the FDA approval of such a drug. The compound in question is called zolbetuximab, and here, it requires patients to be tested for claudin on their tumor biopsies. And this is a targeted therapy that’s able to be added to chemotherapy for patients with metastatic gastric cancer.

There are other novel targets such as FGFR2, which is a new target that has…also a targeted therapy that can be added to chemotherapy. This recently demonstrated exciting benefit in a Phase I/II clinical trial. Then we also have novel immunotherapies. We have early phase trials that are now investigating CAR T therapies targeting stomach cancer and specific markers of stomach cancer, including claudin as well. So those are some of the more exciting Phase I ongoing trials in the advanced stomach cancer setting. In the non-advanced or non-metastatic stomach cancer setting, they’re really trying to…the trials have really focused on trying to improve upon chemotherapy, leading up to surgery to derive better cures for stomach cancer. And here, the addition of immunotherapy to chemotherapy is an eagerly anticipated concept that is now playing out in clinical trials and in larger clinical trials and their final results are eagerly anticipated as well.

Lisa:

And do you have an activation tip, Dr. Gong?

Dr. Jun Gong:

My activation tip for this is it’s never wrong to ask if there is any available clinical trial no matter what setting or stage of disease. Whether it’s early stage or advanced stage, it’s always appropriate to ask every provider, “Is there a clinical trial that you see may be eligible for me or that you believe to be a better option than certain standard of care options?” And we as oncologists are always more than happy to look into these clinical trials and really give you guys a breakdown of what trials may or may not be considered.

Sometimes clinical trials, it’s important to realize that for a particular treatment setting, may not be available at our institution, but there are other institutions within the geography. If you are not geographically limited, even across the country where unavailable clinical trials may be available. We generally refer to what we call a master website. It’s called clinicaltrials.gov. And here it’s a very, in my opinion, patient friendly search engine where you can search your diagnosis and look at available clinical trials. And it’s very easy to have this streamlined approach and even filter out some trials that may not be eligible in collaboration with your doctor.

Tackling Obstacles That Impact Access to Prostate Cancer Care from Patient Empowerment Network on Vimeo.

What obstacles may block access to prostate cancer care? Expert Dr. Channing Paller explains some common issues when seeking care and what is being done in the medical community to improve access.

Channing Paller, MD is the Director of Prostate Cancer Clinical Research at Johns Hopkins Medicine. Learn more about this Dr. Paller.

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Transcript:

Katherine:

Dr. Paller, what about clinical trials? Why should patients consider enrolling, and what are the benefits for them?

Dr. Paller:

I like to tell my patients that once you have metastatic or advanced prostate cancer, we’re not doing placebo on you. If we’re doing placebo, it’s the standard of care plus a new drug, and we want to know if the new drug in combination with the old drug is better than the old drug alone.

And so, I find those patients heroes, in one sense, for the future, right? They’re helping to approve the new drugs of the future, and I also find, oftentimes, those are the patients that do best, because they’re getting to try all of the new drugs of the future before they’re approved. And so, I will have patients that are, I call them chronic trialists because they’ll go through all my new drugs before they’re even approved.

And I love it, and they love it, because they do better than the average, because they’re exploring all of the new therapies. And so, I find those patients heroes, and I really appreciate their efforts. I would say, the most important thing about clinical trials is learning about them, right? And being able to ask the questions. “Well, what phase is that trial?” So, Phase I is really testing safety, and finding the right dose for patients. And so, that’s usually a small number of patients, and looking exactly at, does this work? Do we have a biomarker to follow? What’s the best way to use this new drug?

Phase II starts to look at efficacy, as well as looking at side effects. And so, with Phase II, we really look at, what is the effect? Is it better than what we expected? Does it help these patients – is it better than some of the other drugs?

And then, Phase III are usually large trials that are looking at FDA approval. They’re looking for registration with the FDA, getting approval, and being the new standard of care that’s paid for by insurance companies.

Katherine:

I’d like to back up a bit and talk about the treatments that are currently available. Let’s start with surgery. What role does that play in treating advanced disease?

Dr. Paller:

Surgery is one of the key tools that we use when we’re trying to cure prostate cancer when it’s localized, or just starting to spread. But if it’s too advanced, meaning, spreading to the lymph nodes, we usually don’t recommend surgery. So, surgery is usually used for curative intents, although there is a trial ongoing now, looking at the same question of, is adding surgery to systemic therapy helpful in terms of long-term cure rate, in terms of decreased side effects later, and local symptoms later?

And so, we are asking that question. That is one of the ongoing clinical trials that we’re looking at right now, as a group.

Surgery is terrific. Radiation is terrific. Really working with your team to understand for you, what are the side effects that you would undergo? What are the risks and benefits of each modality that you would like to, or that you’re willing to tolerate? And so, I think the differences between surgery and radiation, for curing patients, are really something that you need to discuss with your provider. The risk of erectile dysfunction, the risk of the local symptoms from the radiation, the risk of having bleeding from your bladder, the risk of bowel problems. Those are all things that that you – urinary incontinence – that you need to discuss with your physician.

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