There are requirements that need to be met before you can enter a clinical trial--inclusion as well as exclusion criteria.  Common inclusion criteria include cancer status, health and performance status, measureable disease, and a requirement for a tumor biopsy.  One of the most common exclusion criteria is prior treatment.  For some clinical trials, you are not eligible if you have had too many prior treatments (this can often be 3 or less) or have already had a drug that is being given in combination with the one that is being tested in the trial.  Click here to learn more about inclusion and exclusion criteria.

ARIEL2 is a phase II trial for a PARP inhibitor called

rucaparib (click here to read more about PARP) for women with platinum-sensitive recurrent ovarian cancer. To meet the eligibility requirement for this trial, you will need to provide a sample of your tumor from a prior surgery as well as a fresh biopsy sample. This critical inclusion criterion requires that you plan ahead. Prior treatment with any PARP inhibitor is one of the exclusion criteria. Again, if a PARP inhibitor makes sense for you, checking to see what trial opportunities are available to you before you start a PARP inhibitor treatment keeps your options open.

Clovis will use the results from this phase II study (ARIEL2) to inform the planned phase III trial (ARIEL3). According to Heidi Giordano, Clovis Oncology Director of Clinical Science for Rucaparib, "ARIEL2 aims to evaluate biomarkers that may predict how a woman with ovarian cancer will respond to rucaparib treatment. Patients will have a biopsy taken and DNA from that tumor will be sequenced so that biomarkers for response can be identified. [The] biomarker tests will identify a patient's BRCA1 and BRCA2 mutation status as well as other markers that may determine their sensitivity to rucaparib." The results from the biomarker testing will be shared with the patient and her physician after she leaves the study. This allows her to use both her Clearity tumor blueprint and the additional information from Clovis to personalize treatments to match her molecular profile.  For more information on ARIEL2, visit www.arielstudy.com.

How to read and use your report

You (and your doctor) have just received the molecular information about your recurrent ovarian cancer. Yes, Clearity and your doctor will help you make sense of your report, but for you to understand what your tumor blueprint means is empowering.  Dig into your report. You will be empowered to participate in selecting your treatment. Page-by-page, your report takes you through (1) the drugs that would be considered ahead of others, (2) what each tested marker looks like in your tumor, and (3) how your tumor compares to other tumors Clearity has tested.

The first page, entitled "Molecular Profiling Summary Report," provides a brief summary of your cancer diagnosis and treatment. This helps you and your physician see your treatment history. The table below your history, Summary of Agents Associated with Clinical Benefit, is about where you are going, what drugs (agents) might be prioritized for your next treatment based on your tumor blueprint (markers).

The Treatment Paradigm column tells you, "NCCN guidelines for treatment of recurrent ovarian cancer." These drugs are recommended by the National Comprehensive Cancer Network as a standard of care. Other drugs on your summary chart are too new or have not been tested specifically in ovarian cancer so they will use a different treatment paradigm, either as clinical trial agents and/or as off-label drugs, which have been approved for the treatment of other cancer types. You get the gist: (1) a specific molecular marker is part of your tumor blueprint, (2) a drug or set of drugs would be prioritized based on your tumor blueprint, and (3) these drugs are available as approved drugs or through clinical trials.

Now, understand how your markers stack up and how to use your markers to identify clinical trial opportunities by digging into pages 2 and 3 of your report. Click here to read the rest of this article on Clearity's website. 

As you know, each biomarker (test) in the tumor molecular profile is there because it is associated with response to the drugs commonly used or in clinical trials for ovarian cancer treatment.  The evidence for each of the tests can be found on our website (http://www.clearityfoundation.org/healthcare-pros/drugs-and-biomarkers.aspx). That evidence comes from clinical research studies carried out in ovarian and other cancers.   

We would like to increase the amount of evidence for ovarian cancer by using the results from your Clearity profile (in an anonymous way of course), but to do that, we need to know how your profile was used by your doctor to select your treatment (we need you to arrange to have your oncology flowsheets sent to us for that)-and most importantly, how you are doing.  We are regularly in touch with some of you but would like to hear from everyone. We believe that your contribution to this analysis may help you (if needed in the future) and can also help others.  Please contact us at [email protected] or at 858-657-0282 to tell us how you are and learn how you can help in this effort.