MGH: A Guide to Understanding Clinical Trials" Part 1

Although this article is not specific to ovarian cancer, "A Guide to Understanding Clinical Trials" is important info for all of us.

Published on the MassGeneral website, I am including the full text below. This is part 1.

When a new disease such as COVID-19 is discovered, it is up to doctors and scientists to investigate how the disease behaves so treatments can be developed and tested.
There are numerous clinical trials for COVID-19 therapeutics across the globe, and results from these trials (often uncontrolled and published in non-peer reviewed journals) are being released on a regular basis.

With all of the new information coming out so rapidly, it can be confusing to understand what these results mean. The Mass General Research Institute is providing a resource to explain how clinical trials work and share what makes for a strong clinical trial with clear and promising results.

What are clinical trials and why are they important?

Clinical trials are scientific studies designed to test the safety and usefulness of new medical interventions such as treatments, devices, preventative care, screening or diagnostic procedures, and more.

They are crucial to the advancement of strong science and patient care because, if well-designed, they can validate the performance of an intervention under controlled circumstances to ensure it is safe, effective and provides measurable benefits to patients.

How do they work?

Scientists typically conduct research on a disease or potential treatment for several years to lay a foundation for a clinical trial. During this time, they are gathering as much information as possible to learn about how a disease behaves, what it does to the body, which populations are at risk for it and what may be potential targets for treatment. Research can move into the next phase, called preclinical or translational research, once enough promising and validated reproducible data have been generated to justify further testing.

Preclinical trials are the first opportunity to see how a treatment may work in specific non-human models. In this stage, scientists must follow strict guidelines to test their interventions in vitro (in a petri dish or test tube) or in vivo (in a living organism such as an animal model) before moving on to human trials. If the findings are promising, investigators must fill out the necessary paperwork and get approval so the study can move onto a Phase I clinical trial.

What happens in the four phases of clinical trials?

According to the Federal Drug Administration (FDA), there are four phases of clinical trials that each inform decisions made in the next phase:

Phase 1

• Focus: Establishing the safety and correct dosage of a treatment
• Time frame: Typically lasts several months
• Sample size: 20-100 participants who are either healthy or have the targeted condition
• Bottom line: Designed to understand how the treatment and dosage are tolerated within the human body

Phase II (click on "Phase II" for more info)

Phase III (click on "Phase III" for more info)

Phase IV (click on "Phase IV" for more info)

Ovarian Cancer National Conference, Oct. 2020

The Ovarian Cancer Research Alliance (OCRA) will be holding its national conference from Sept 29 - Oct 2.

In their own words:
Join us (virtually) September 29 – October 2!

The global pandemic may have upended our original plans but it can’t stop us from uniting the ovarian cancer community from all over the world.  The format may be different (no in-person hugs) but we promise to provide the same eye-opening, educational content from the country’s top researchers and doctors about every aspect of ovarian cancer, including treatment, wellness, advocacy and survivorship, as we always have but this time with a few surprises. 

While we’re undeniably disappointed that we won’t be able to see everyone in person, there is a significant up-side to moving our conference online: Now anyone who wants to attend will have the chance, no travel necessary! We’re excited to expand our strong and welcoming community to reach even more people with important updates in the ovarian cancer field and OCRA’s patient support programs.

Past attendees have said that this conference is a can’t miss event for the ovarian cancer community:  a gathering of hope, inspiration, new found knowledge and sisterhood.

We are excited for you to join us!

To register, follow this link.

Nirapamib Wins FDA Approval for Front-Line Treatment of OC

Nirapamib a PARP inhibitor, is now available for maintenance treatment in all women with advanced epithelial, primary peritoneal or fallopian cancer regardless of BRCA mutation status who have responded to platinum based chemo.

Olaparib (Lynparza) is only approved for women with germline BRCA mutations.

PARP inhibitors work by preventing cancer cells from repairing their DNA damage caused by previous anticancer medications.

Despite FDA approval for front-line therapy after platinum based chemo, the side effects may make the drug intolerable for some women. These include anemia, neutropenia, GI toxicity and fatigue.

To read more about Nirapamib's approval, follow this link.

Going Through Divorce While Undergoing Treatment

This story appeared on SurvivorNet.com and it's about one woman's journey through ovarian cancer while undergoing a divorce.

I've know several women (of all types of cancer) go through divorce while undergoing treatment. It's something that's not talked about much but certainly crosses some women's minds.

You can read the article by following this link.

Nirapamib Plus Bevacizumab: a Winning Combo

Recent findings presented at the 2020 ASCO Virtual Scientific Program confirmed that combination nirapamib (Zejula) plus bevacizumab (Avastin) showed a 66% reduction in the risk of disease progression or death.

The results from this phase II study confirms earlier findings that showed improved clinical outcomes in the AVANOVA trial that were clinically significant.

Patients with recurrent platinum-sensitive epithelial, fallopian tube or peritoneal cancer and high-grade serous or endometrioid histology participated in the study. Additionally, patients with any number of prior therapies were allowed to participate.

The results of the study led by a group from Denmark is now set to move into phase III. If this continues to be successful, it will likely change treatment protocols for recurrent OC.

To read more about the study, follow this link.

DF Doctors Present Findings

Drs. Liu, Brady and Matulonis from Dana Farber, recently presented their findings on a phase III study looking at recurrent, platinum-sensitive ovarian cancer (OC) at this year's ASCO Virtual Scientific Program.

The study looked at treating recurrent OC with three different treatment options: platinum based chemo, treatment with olaparib (PARP inhibitor) or olaparib plus cediranib (anti-angiogenic).

The study did not meet its primary endpoint of progression-free survival but the authors felt that the results showed a comparable effect to the more traditional platinum based chemo. Of note however, the combination of olaparib and cediranib were more successful in patients with germ-line BRCA mutations.

To read more about the study, follow this link.

Scientists identify factors for predicting which patients with ovarian cancer won’t benefit from immunotherapy-PARP inhibitor combination - Dana-Farber Cancer Institute | Boston, MA

Scientists identify factors for predicting which patients with ovarian cancer won’t benefit from immunotherapy-PARP inhibitor combination - Dana-Farber Cancer Institute | Boston, MA: In patients with advanced ovarian cancer, a combination of drugs known as immune checkpoint inhibitors and PARP inhibitors can produce powerful remissions, clinical trials have shown, but up until now investigators haven’t been able to predict which patients won’t benefit from the treatment and should explore other options.