Trial Outcomes & Findings for A Study of Serum Folate Levels in Patients Treated With Olaparib (NCT NCT04024254)

NCT ID: NCT04024254

Last Updated: 2025-11-21

Results Overview

The number of patients with ovarian and breast cancers who were treated with olaparib and developed folate deficiency was counted.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome 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.
• Results posted on: 2025-11-21

Participant Flow

The protocol started in August 2020 and completed in August 2022. Patients were recruited from the Gynecologic Oncology and Breast Oncology clinics at a major medical center.

Patients who were planned to receive the PARP inhibitor, Olaparib for the treatment for Ovarian or Breast cancer were eligible for the study. After obtaining consent, screening activities included baseline blood work and physical exam. One of the ten subjects was excluded as it was revealed that she had received prior PARP inhibitor treatment on a blinded trial.

Participant milestones

Measure	Folic Acid Folic Acid supplement 1 mg by mouth daily Folic Acid Tablet: Folic Acid 1 mg by mouth daily	No Supplementation No Folate supplementation
Overall Study STARTED	2	7
Overall Study COMPLETED	2	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Serum Folate Levels in Patients Treated With Olaparib

Baseline characteristics by cohort

Measure	Folic Acid Supplementation Group n=2 Participants Folic Acid supplement 1 mg by mouth daily Folic Acid Tablet: Folic Acid 1 mg by mouth daily	No Supplementation n=7 Participants No Folate supplementation	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=68 Participants	3 Participants n=76 Participants	5 Participants n=48 Participants
Age, Categorical >=65 years	0 Participants n=68 Participants	4 Participants n=76 Participants	4 Participants n=48 Participants
Age, Continuous	49 years n=68 Participants	66 years n=76 Participants	64 years n=48 Participants
Sex: Female, Male Female	2 Participants n=68 Participants	7 Participants n=76 Participants	9 Participants n=48 Participants
Sex: Female, Male Male	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=68 Participants	7 Participants n=76 Participants	9 Participants n=48 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Asian	1 Participants n=68 Participants	0 Participants n=76 Participants	1 Participants n=48 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Black or African American	0 Participants n=68 Participants	5 Participants n=76 Participants	5 Participants n=48 Participants
Race (NIH/OMB) White	1 Participants n=68 Participants	2 Participants n=76 Participants	3 Participants n=48 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants	0 Participants n=76 Participants	0 Participants n=48 Participants
Region of Enrollment United States	2 participants n=68 Participants	7 participants n=76 Participants	9 participants n=48 Participants
Folate levels at baseline	10.5 ng/mL n=68 Participants	18.6 ng/mL n=76 Participants	14.6 ng/mL n=48 Participants

PRIMARY outcome

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.

The number of patients with ovarian and breast cancers who were treated with olaparib and developed folate deficiency was counted.

Outcome measures

Measure	Folic Acid Supplementation Arm n=2 Participants Folic Acid supplement 1 mg by mouth daily	No Supplementation n=7 Participants No Folate supplementation
Number of Participants Who Have Developed Folate Deficiency (Serum Folate Level < 7 ng/ml) on Olaparib	2 Participants	6 Participants

PRIMARY outcome

Timeframe: From the beginning of olaparib treatment until the development of folate deficiency

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

The number of weeks between the beginning of olaparib treatment and the development of folate deficiency

Outcome measures

Measure	Folic Acid Supplementation Arm n=2 Participants Folic Acid supplement 1 mg by mouth daily	No Supplementation n=6 Participants No Folate supplementation
Timing of Folate Deficiency Development	4 weeks Interval 2.0 to 6.0	3.4 weeks Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Folic Acid Supplementation Arm n=2 Participants Folic Acid supplement 1 mg by mouth daily	No Supplementation n=7 Participants No Folate supplementation
The Number of Participants Who Developed Decreased Hemoglobin by ≥ 1 g/dl Relative to Baseline	1 Participants	2 Participants

SECONDARY outcome

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.

Population: We calculated the average folate level for each data point in each arm of the study.

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.

Outcome measures

Measure	Folic Acid Supplementation Arm n=2 Participants Folic Acid supplement 1 mg by mouth daily	No Supplementation n=7 Participants No Folate supplementation
Serum Folate 12 week	24.1 ng/ml Interval 9.6 to 38.6	6.1 ng/ml Interval 4.2 to 7.6
Serum Folate 14 weeks	24.0 ng/ml Interval 24.0 to 24.0	10.5 ng/ml Interval 6.6 to 13.7
Serum Folate 5 month	18.5 ng/ml Interval 8.3 to 28.7	9.5 ng/ml Interval 3.7 to 18.4
Serum Folate 11 month	5.9 ng/ml Interval 5.1 to 6.6	6.8 ng/ml Interval 4.3 to 9.3
Serum Folate 12 month	12.4 ng/ml Interval 12.4 to 12.4	9.3 ng/ml Interval 4.5 to 14.1
Serum Folate 10 week	15.9 ng/ml Interval 15.9 to 15.9	8.1 ng/ml Interval 1.6 to 11.2
Serum Folate 2 week	5.5 ng/ml Interval 3.6 to 7.3	7.7 ng/ml Interval 2.5 to 16.2
Serum Folate 10 month	11.6 ng/ml Interval 8.5 to 14.7	7.5 ng/ml Interval 7.5 to 7.5
Serum Folate 30 day follow up	6.0 ng/ml Interval 5.2 to 6.5	9.3 ng/ml Interval 3.2 to 16.2
Serum Folate 6 week	8.4 ng/ml Interval 7.5 to 9.3	7.8 ng/ml Interval 5.4 to 13.8
Serum Folate 8 week	3.6 ng/ml Interval 3.6 to 3.6	4.0 ng/ml Interval 1.7 to 6.7
Serum Folate 4 week	6.5 ng/ml Interval 5.5 to 21.5	4.6 ng/ml Interval 2.0 to 9.2
Serum Folate 6 month	11.2 ng/ml Interval 3.8 to 18.7	5.6 ng/ml Interval 2.8 to 8.9
Serum Folate 7 month	10.5 ng/ml Interval 9.3 to 10.8	6.8 ng/ml Interval 5.0 to 8.8
Serum Folate 8 month	13.6 ng/ml Interval 10.5 to 16.7	5.8 ng/ml Interval 5.5 to 6.1
Serum Folate 9 month	9.1 ng/ml Interval 9.1 to 9.1	8.2 ng/ml Interval 8.2 to 8.2

SECONDARY outcome

Timeframe: Over 12 months while on olaparib therapy.

The number of patients requiring blood transfusions during olaparib treatment was counted.

Outcome measures

Measure	Folic Acid Supplementation Arm n=2 Participants Folic Acid supplement 1 mg by mouth daily	No Supplementation n=7 Participants No Folate supplementation
Number of Participants Requiring Blood Transfusions	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Over 12 months while on olaparib therapy.

The number of subjects requiring interruptions in olaparib treatment for any reason was counted.

Outcome measures

Measure	Folic Acid Supplementation Arm n=2 Participants Folic Acid supplement 1 mg by mouth daily	No Supplementation n=7 Participants No Folate supplementation
Number of Participants Requiring Olaparib Dose Interruptions	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Over 12 months while on olaparib therapy.

The number of participants requiring olaparib dose reductions for any reason was counted.

Outcome measures

Measure	Folic Acid Supplementation Arm n=2 Participants Folic Acid supplement 1 mg by mouth daily	No Supplementation n=7 Participants No Folate supplementation
Number of Participants Requiring Olaparib Dose Reductions for Any Reason	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Over 12 months while on olaparib therapy

The number of subjects who had their olaparib treatment discontinued was counted.

Outcome measures

Measure	Folic Acid Supplementation Arm n=2 Participants Folic Acid supplement 1 mg by mouth daily	No Supplementation n=7 Participants No Folate supplementation
Number of Participants Requiring Olaparib Discontinuation	0 Participants	1 Participants

Adverse Events

Folic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Supplementation

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Folic Acid n=2 participants at risk Folic Acid supplement 1 mg by mouth daily Folic Acid Tablet: Folic Acid 1 mg by mouth daily	No Supplementation n=7 participants at risk No Folate supplementation
General disorders FATIGUE	0.00% 0/2 • Adverse events of olaparib therapy were collected for active participants from a range of 3 - 12 months. Adverse effects were measured using CTCAE v4.0	14.3% 1/7 • Number of events 1 • Adverse events of olaparib therapy were collected for active participants from a range of 3 - 12 months. Adverse effects were measured using CTCAE v4.0
Gastrointestinal disorders NAUSEA	0.00% 0/2 • Adverse events of olaparib therapy were collected for active participants from a range of 3 - 12 months. Adverse effects were measured using CTCAE v4.0	14.3% 1/7 • Number of events 1 • Adverse events of olaparib therapy were collected for active participants from a range of 3 - 12 months. Adverse effects were measured using CTCAE v4.0

Additional Information

Dr Lydia Usha

Rush University Medical Center

Phone: 312-942-5904

Email: Lydia_Usha@rush.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place