A Study of Serum Folate Levels in Patients Treated With Olaparib (NCT04024254) | Clinical Trial Compass
CompletedPhase 4
A Study of Serum Folate Levels in Patients Treated With Olaparib
United States10 participantsStarted 2020-07-21
Plain-language summary
This is a study investigating folate deficiency (lack of folic acid in the blood) in patients who take the drug olaparib to treat their advanced ovarian or breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Willing and able to provide signed informed consent
* Female, post-menopausal, ≥18 years of age inclusive, at the time of signing the consent form
* 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:
* Haemoglobin ≥ 9 g/dL with no blood transfusion in the past 28 days
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤ 5x ULN
* Patients must have creatinine clearance estimated of ≥51 mL/min
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1).
* Patients must have a life expectancy ≥ 16 weeks.
* At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT and is suitable for repeated assessment.
Exclusion Criteria:
* Patients with folic acid deficiency, defined as folate \<7 ng/mL, or those taking folic acid supplementation within 30 days of olaparib initiation.
* Other malignancy unless curatively treated with no evidence of disease for ≥5 years except…
What they're measuring
1
Number of Participants Who Have Developed Folate Deficiency (Serum Folate Level < 7 ng/ml) on Olaparib
Timeframe: Serum folate levels were measured in each enrolled subject: at baseline, then every 2 weeks X 3 months, then monthly X 9 months. Accrual occurred over a 2-year period.
2
Timing of Folate Deficiency Development
Timeframe: From the beginning of olaparib treatment until the development of folate deficiency