A Study of Serum Folate Levels in Patients Treated With Olaparib

A Study of Serum Folate Levels in Patients With Treated With Olaparib.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Ovarian Cancer; Folic Acid Deficiency
• Intervention / Treatment: Drug: Folic Acid Tablet

Detailed Description

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. The primary goal of this study is to determine the frequency and timing of folate deficiency, and to learn more about whether giving folic acid supplementation (vitamin) will help delay or avoid deficiency in these patients. Deficiency can cause doctors to reduce or stop treatment with olaparib. In this case, patients are not getting the best treatment for their cancer due to the unwanted side effect.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma. Patients with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
• Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
• Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
• Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
• Patients with symptomatic uncontrolled brain metastases.
• Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
• Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
• Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Patients with known active hepatitis (i.e. Hepatitis B or C).
• 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
• Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.
• Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
• Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
• Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
• Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).
• Participation in another clinical study with an investigational product administered in the last 1 month
• Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
• Patients with a known hypersensitivity to folic acid or any of the excipients of the product.
• Involvement in the planning and/or conduct of the study
• Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
• Previous enrollment in the present study
• Breast feeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Folic Acid supplementation; Folic Acid supplement 1 mg by mouth daily	Drug: Folic Acid Tablet; Folic Acid 1 mg by mouth daily
No Intervention: No Folic Acid Supplementation; No Folic Acid supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Have Developed Folate Deficiency (Serum Folate Level < 7 ng/ml) on Olaparib	The number of patients with ovarian and breast cancers who were treated with olaparib and developed folate deficiency was counted.	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.
Timing of Folate Deficiency Development	The number of weeks between the beginning of olaparib treatment and the development of folate deficiency	From the beginning of olaparib treatment until the development of folate deficiency

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants Who Developed Decreased Hemoglobin by ≥ 1 g/dl Relative to Baseline	To evaluate the effect of olaparib on hemoglobin level in both arms of the study as compared to baseline before the beginning of the olaparib treatment	Hemoglobin 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.
Serum Folate	To evaluate the effect of folic acid supplementation on serum folate levels as compared to the no Folate supplementation arm. Serum folate was measured every 2 weeks for the first 3 months, and then monthly for 9 months during olaparib therapy.	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.
Number of Participants Requiring Blood Transfusions	The number of patients requiring blood transfusions during olaparib treatment was counted.	Over 12 months while on olaparib therapy.
Number of Participants Requiring Olaparib Dose Interruptions	The number of subjects requiring interruptions in olaparib treatment for any reason was counted.	Over 12 months while on olaparib therapy.
Number of Participants Requiring Olaparib Dose Reductions for Any Reason	The number of participants requiring olaparib dose reductions for any reason was counted.	Over 12 months while on olaparib therapy.
Number of Participants Requiring Olaparib Discontinuation	The number of subjects who had their olaparib treatment discontinued was counted.	Over 12 months while on olaparib therapy

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Lydia Usha, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: olaparib; breast cancer; ovarian cancer; folic acid deficiency
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Nutrition Disorders; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Ovarian Neoplasms; Breast Neoplasms; Folic Acid Deficiency; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pterins; Pteridines; Folic Acid
• Other Study ID Numbers: 18070604

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes