Ovarian CancerPhase 4NCT04024254

A Study of Serum Folate Levels in Patients Treated With Olaparib

A Phase 4 study testing Folic Acid Tablet in people with Ovarian Cancer and Breast Cancer, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Ovarian Cancer, Breast Cancer, Folic Acid Deficiency
What is being tested?: Folic Acid Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 21 Jul 2020to 31 Dec 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Ovarian Cancer, Breast Cancer, Folic Acid Deficiency
Being tested: Folic Acid Tablet
Keywords: ovarian cancer, breast cancer, olaparib, folic acid deficiency
Medical subject headings: Ovarian Neoplasms, Breast Neoplasms, Folic Acid Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Folic Acid TabletDrug
Folic Acid 1 mg by mouth daily

Study groups in NCT04024254
Study group	Role	What they receive
Folic Acid supplementation	Experimental	Folic Acid supplement 1 mg by mouth daily Receives: Drug: Folic Acid Tablet
No Folic Acid Supplementation	No intervention	No Folic Acid supplementation.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: From the beginning of olaparib treatment until the development of folate deficiency

Secondary outcomes (6)

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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Over 12 months while on olaparib therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 202031 Dec 2025

First posted18 Jul 2019
Study start21 Jul 2020
Primary completion31 Dec 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04024254
Sponsor's protocol ID: 18070604
Status last verified: Feb 2026
First submitted: 10 Jul 2019
Last updated: 4 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Serum Folate Levels in Patients With Treated With Olaparib.
ClinicalTrials.gov ID: NCT04024254
Acronym / sponsor ID: 18070604
Conditions: Ovarian Cancer, Breast Cancer, Folic Acid Deficiency
Keywords: ovarian cancer, breast cancer, olaparib, folic acid deficiency
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: 21 Jul 2020 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 18 Jul 2019 (actual)
Results: Posted 21 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Folic Acid supplementation	Experimental	Drug: Folic Acid TabletFolic Acid supplement 1 mg by mouth daily
No Folic Acid Supplementation	No intervention	–No Folic Acid supplementation.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Folic Acid TabletFolic Acid 1 mg by mouth daily	Drug	Folic Acid supplementation

Primary outcome

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

6 secondary outcomes

The Number of Participants Who Developed Decreased Hemoglobin by ≥ 1 g/dl Relative to Baseline
Time frame: 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
Time frame: 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
Time frame: Over 12 months while on olaparib therapy.
Number of Participants Requiring Olaparib Dose Interruptions
Time frame: Over 12 months while on olaparib therapy.
Number of Participants Requiring Olaparib Dose Reductions for Any Reason
Time frame: Over 12 months while on olaparib therapy.
Number of Participants Requiring Olaparib Discontinuation
Time frame: Over 12 months while on olaparib therapy

Results and safety

Results posted to the registry on 21 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Folic Acid	2	2
No Supplementation	7	7

Primary outcome: Number of Participants Who Have Developed Folate Deficiency (Serum Folate Level < 7 ng/ml) on Olaparib

Time frame: 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.. Count of participants. Unit: Participants

Measure	Folic Acid Supplementation Arm n = 2	No Supplementation n = 7
Value	2	6

Primary outcome: Timing of Folate Deficiency Development

Time frame: From the beginning of olaparib treatment until the development of folate deficiency. Mean (Full Range). Unit: weeks

Measure	Folic Acid Supplementation n = 2	No Supplementation n = 6
Value	4 (2 to 6)	3.4 (2 to 8)

Population analysed: Only 6 subjects in the no folate supplementation arm developed folate deficiency.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events of olaparib therapy were collected for active participants from a range of 3 - 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Folic Acid	0 of 2 (0%)	0 of 2 (0%)	0 of 2
No Supplementation	0 of 7 (0%)	2 of 7 (28.6%)	2 of 7

Limitations and caveats (from the sponsor): 1. Low accrual at a single center led to a small sample size. 2. Close serum folate monitoring with early intervention for folate deficiency could have prevented more severe anemia, blood transfusions, and olaparib dose reductions. 3. Subjects were not blinded to results and may have altered their behavior. They were encouraged to hold folate-containing multivitamins but were not required to. 4. Olaparib-induced nausea and poor oral intake could have contributed to folate deficiency.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lydia Usha, MD principal investigator

Rush University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Folic Acid Tablet in people with Ovarian Cancer and Breast Cancer, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Have Developed Folate Deficiency (Serum Folate Level < 7 ng/ml) on Olaparib (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04024254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.