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Serum Folate in Patients Treated with Olaparib

Serum Folate in Patients Treated with Olaparib

Clinicaltrials.gov identifier:
NCT04024254

Treatment:
Breast, Ovarian

Study Contact Information:

For questions about the study, contact the study nurse Lois Winkelman at 312-942-2417 or by email.


Serum Folate in Patients Treated with Olaparib

About the Study

This is a study looking at folate deficiency (lack of folic acid in the blood) in patients who take the drug olaparib (Lynparza) to treat their advanced ovarian or breast cancer. The main goal of this study is to measure how often and when folate deficiency is most likely to occur; and to learn more about whether giving folic acid supplements (vitamins) will help delay or avoid deficiency in these patients. Folate deficiency can cause side effects and lead to reduction or stopping of treatment with olaparib.

What will you be asked to do?

  • If your oncologist determines that you need treatment with olaparib and you want to participate in this study, you will first sign a consent form and then undergo a screening process, which will include a routine blood sample to evaluate your baseline (starting) blood counts and folic acid levels, to check if you are eligible to participate in the study. If you are eligible, you will begin taking olaparib at the recommended dose (twice daily).  We will try to schedule your study visits and tests so that you will not need to come to the office/clinic more than you would to receive your normal medical care.
  • For the first 3 months, you will come to the clinic every 2 weeks for laboratory testing while on olaparib. You will be asked to provide a blood sample (2 tubes, or about 2 tbsp.) to assess your blood counts and folic acid level.  
  • Following this, blood samples will be required once a month for as long as you are on olaparib. If you have folic acid deficiency at any time during the first 3 months of therapy, a repeat blood test will be drawn in 2 weeks or at your next appointment. If a folic acid deficiency is confirmed and your doctor diagnoses you with anemia (low red blood cell count), then you will be randomized to receive either an oral (taken by mouth) folic acid supplement at 1 mg daily or no supplement. “Randomized” means that you will be placed into one of the two study treatment groups by chance. You will have a 50/50 chance of being put into either group. Neither you nor the research doctor will choose the group you are placed in. One group of patients will be assigned to receive the folate supplement and the second group will not receive the supplement. There is no blinding with this study; you and your doctor will know whether you are receiving the supplement or not.
  • You will have weekly blood draws to monitor your blood counts, folic acid level and potential need for transfusions. If you develop folic acid deficiency and your Hemoglobin is < 8 g/dL, you will start folic acid supplementation at 1 mg daily even if you were previously assigned to receive no supplement. Throughout the study, you will continue to follow up with your oncologist at regular clinic appointments. If at any time your oncologist believes you should no longer be treated with olaparib, you will be taken off the study 30 days after stopping olaparib, at which time a final sample of your blood will be drawn for folic acid levels and blood counts.  

As an optional sub-study, we also will ask for your consent to access previously stored samples of your tumor for additional analysis. If you decide not to participate in the tissue sample portion of the study, you can still participate in the main study.

Study Locations

The following are participating institutions:

  • Chicago, IL: Rush University Medical Center: Contact Lois Winkelman, RN at: 312-942-2417

Study Lead Investigator

Dr. Lydia Usha, MD
Associate Professor of Medicine
Director, Rush Inherited Susceptibility to Cancer (RISC) Center
The Rush Cancer Institute, Rush University
1725 W. Harrison St. Suite 809
Chicago, IL 60612

This Study is Open To:

Women can participate if they are:

  • Post-menopausal, ≥18 years of age inclusive, at the time of consent
  • Individuals who have ovarian cancer or breast cancer who are recommended to start olaparib
  • Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Hemoglobin ≥ 9 g/dL with no blood transfusion in the past 28 days
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Please note that this is a partial list of inclusion criteria.

This Study is Not Open To:

People are excluded if they:

  • Women with folic acid deficiency, defined as folate <7 ng/mL, or those taking folic acid supplementation within 30 days of olaparib initiation.
  • Any previous treatment with PARP inhibitor, including Olaparib.
  • Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
  • Participation in another clinical study with an investigational product administered in the last 1 month