Clinical Trial TitleA study of serum folate levels in patients treated with olaparib.
National Clinical Trial Number:NCT04024254
Clinical Trial Protocol Description:
This is a pilot, investigator-initiated study evaluating the prevalence (commonness) and timing of folate deficiency (lack of folic acid in the blood) in patients who take the drug olaparib to treat their advanced ovarian or breast cancer. The primary goal of this study is to determine the frequency and timing of folate deficiency in these patients, and to learn more about whether giving folic acid supplements will help delay or avoid deficiency in these patients. Deficiency can cause doctors to reduce or stop treatment with olaparib. In this case, patients on the drug are not getting the best treatment for their cancer due to the unwanted side effect (folate deficiency).
Eligible patients will be randomized 1:1 (equal chance, like the flip of a coin) to receive folic acid supplements or a placebo. If a patient in the placebo group develops more severe folic acid deficiency during the study, then they will receive folic acid supplements regardless of their initial treatment assignment. Participants will be asked to come to the clinic every 2 weeks for the first 3 months. The study team will try to schedule these visits to coincide with the participants regular medical appointments. After that, study visits will take place about one time every month. Participants will remain in the study for as long as they take olaparib. 30 days after stopping olaparib, they will have final blood tests done for this study.
More information can be found on the website clinicaltrials.gov by searching for NCT04024254.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age at enrollment.
- Have ovarian cancer or breast cancer and have been recommended to start olaparib.
- Are postmenopausal or evidence of non-childbearing status for women of childbearing potential.
- Have normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
You will be excluded from the study if any of the following criteria apply to you:
- Have folic acid deficiency, defined as folate <7 ng/mL, or those taking folic acid supplementation within 30 days of olaparib initiation.
- Have had any previous treatment with PARP inhibitor, including olaparib.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.