Clinical Study

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study Of Olaparib Maintenance Monotherapy In Patients With Brca Mutated Advanced (Figo Stage III-Iv) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Posted Date: Mar 25, 2014

  • Investigator: Eric Eisenhauer
  • Co-Investigator: Kathy Amanns
  • Specialties:
  • Type of Study: Drug

You have been diagnosed with ovarian cancer, primary peritoneal cancer (the lining of the abdomen) or fallopian tube cancer. To participate in this study you will be tested for a specific type of genetic mutation in the BRCA genes. A mutation is a change in your deoxyribonucleic acid (DNA) which affects how some processes in the body work. You had an improvement in your cancer (response) following first line platinum based chemotherapy. This study is being carried out to see if a new treatment being tested, called olaparib, is effective in treating your ovarian cancer and preventing it coming back as quickly as it could otherwise do without any medication. The current medical practice in your situation is not to take further medications until the cancer comes back. Approximately 344 other subjects like you will take part in approximately 200 hospitals worldwide. DNA is used to store genetic information (genes) for making proteins in your cells. Cells generally carry two good copies of the gene for any given protein. Proteins have specific jobs in the body like carrying oxygen (hemoglobin) and sending messages (insulin). BRCA stands for Breast Cancer Susceptibility gene. In normal cells, BRCA1 and BRCA2 proteins help to repair DNA and if you have a mutation in these genes at birth there is an increased chance of getting cancer (mainly ovarian or breast cancer). The increased risk is likely due to the fact that any damage to the remaining good copy of either gene leaves a cell without functional BRCA1 or BRCA2 protein and unable to repair DNA properly. However, a cancer cell without BRCA1 or BRCA2 protein function to repair DNA can be particularly sensitive to treatment with olaparib. Olaparib is a PARP (poly [adenosine diphosphate-ribose] polymerase) inhibitor (this means that olaparib stops PARP from working – PARP is a protein which tries to fix damaged DNA). In normal cells, olaparib will stop the damaged DNA from repairing itself but there are other ways of repairing DNA and so these normal cells can still survive. However, cancer cells without BRCA1 or BRCA2 protein function can’t carry out these repairs. The combined effect of knocking out both DNA repair mechanisms is so severe that the cancer cells die. Therefore, olaparib is being tested in subjects who have a BRCA1 and/or BRCA2 mutated cancers. Approximately 2000 patients suffering from a variety of cancers, including ovarian, have already taken olaparib at different doses (ranging from 10 mg once daily to 600 mg twice a day, either on its own or in combination with another chemotherapy agent). This study treatment has not yet been approved by the Food and Drug Administration (FDA).

Criteria:

You Have Been Diagnosed With Ovarian Cancer, Primary Peritoneal Cancer (The Lining Of The Abdomen) Or Fallopian Tube Cancer. To Participate In This Study You Will Be Tested For A Specific Type Of Genetic Mutation In The Brca Genes. A Mutation Is A Change In Your Deoxyribonucleic Acid (Dna) Which Affects How Some Processes In The Body Work. You Had An Improvement In Your Cancer (Response) Following First Line Platinum Based Chemotherapy.

Keywords:

Advanced, Brca, Gynecologyc Oncology, Maintenance, Ovarian Cancer

For More Information:

Kathy Amanns
513-584-4528
kathy.amanns@uc.edu

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