Trial Outcomes & Findings for PARP Inhibition for Gliomas (PI-4G or π4g) (NCT NCT05297864)
NCT ID: NCT05297864
Last Updated: 2025-05-23
Results Overview
Number of patients who experience adverse events with individualized starting dose (ISD) of niraparib using CTCAE v5.0
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 17 months
Results posted on
2025-05-23
Participant Flow
This study was a multisite study, but only enrolled participants at University of Oklahoma Health Sciences Center Stephenson Cancer Center (OUHSC SCC). The study activated at SCC on 4/14/2022 and the last patient went off study on 2/6/2024. The first patient enrolled on 6/9/2022 and the last patient enrolled on 9/28/2023.
Of the 15 enrolled participants, 9 met inclusion criteria and were evaluable.
Participant milestones
| Measure |
Niraparib Treatment
Patients will be treated with individualized starting dose of Niraparib.
Niraparib: The starting dose will be 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PARP Inhibition for Gliomas (PI-4G or π4g)
Baseline characteristics by cohort
| Measure |
Niraparib Treatment
n=9 Participants
Patients were treated with individualized starting dose of Niraparib.
Niraparib: The starting dose was 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
|
Primary Site of Cancer
Astrocytoma
|
2 number of participants
n=5 Participants
|
|
Primary Site of Cancer
GBM
|
6 number of participants
n=5 Participants
|
|
Primary Site of Cancer
Oligodendroglioma
|
1 number of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 17 monthsPopulation: All patients enrolled in study
Number of patients who experience adverse events with individualized starting dose (ISD) of niraparib using CTCAE v5.0
Outcome measures
| Measure |
Niraparib Treatment
n=9 Participants
Patients will be treated with individualized starting dose of Niraparib.
Niraparib: The starting dose will be 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
Number of Patients Who Experience Adverse Events
|
9 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsPopulation: study terminated early, only 6 participants in dose expansion phase.
Percentage of patients who respond to niraparib monitored by disease control rate (stable disease and better) using RANO from start of treatment for up to 12 months.
Outcome measures
| Measure |
Niraparib Treatment
n=6 Participants
Patients will be treated with individualized starting dose of Niraparib.
Niraparib: The starting dose will be 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
Efficacy of Treatment in Dose Expansion Phase
|
0 participants
|
PRIMARY outcome
Timeframe: 5 monthsPopulation: Patients who received at least one dose of Niraparib
Number of patients who experience toxicities (defined as grade 3 or 4 adverse events) with individualized starting dose (ISD) of niraparib using CTCAE v5.0
Outcome measures
| Measure |
Niraparib Treatment
n=9 Participants
Patients will be treated with individualized starting dose of Niraparib.
Niraparib: The starting dose will be 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
Number of Patients Who Experience Toxicities With Individualized Starting Dose (ISD) of Niraparib Using CTCAE v5.0
|
5 Participants
|
SECONDARY outcome
Timeframe: 20 monthsPopulation: Patients who enrolled in study and took at least one dose of study drug. Patient must be in the dose expansion phase.
Proportion of patients who have progression-free survival from date of study entry until the first documented date of progression or date of death, whichever comes first.
Outcome measures
| Measure |
Niraparib Treatment
n=6 Participants
Patients will be treated with individualized starting dose of Niraparib.
Niraparib: The starting dose will be 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
Progression Free Survival in Dose Expansion Phase
|
1.62 Months
Interval 1.06 to
The upper bound confidence interval never dropped before the 50% margin and therefore cannot be calculated.
|
SECONDARY outcome
Timeframe: 20 monthsPopulation: Patients who enrolled in study and consumed at least one dose of study drug. Patient must be in the dose expansion phase
Proportion of patients with overall survival on the study defined as time from date of study entry to death by any cause.
Outcome measures
| Measure |
Niraparib Treatment
n=6 Participants
Patients will be treated with individualized starting dose of Niraparib.
Niraparib: The starting dose will be 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
Overall Survival in Dose Expansion Phase
|
10.81 Months
Interval 4.63 to
The upper bound confidence interval never passed the 50% margin and therefore cannot be calculated.
|
SECONDARY outcome
Timeframe: up to 4 yearsPopulation: Outcome measure was not calculated due to early study termination-- no patients experienced response to treatment. Due to this, we cannot calculate a duration of response because we don't have any responders to evaluate
Duration of response in patients treated with niraparib defined as time from date of first response (stable disease or better) to the first date of non-response post treatment on the study.
Outcome measures
Outcome data not reported
Adverse Events
Niraparib Treatment
Serious events: 1 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Niraparib Treatment
n=9 participants at risk
Patients will be treated with individualized starting dose of Niraparib. Since each patient's dose will be individualized based on patients' weight and platelet count, arms/groups are combined.
Niraparib: The starting dose will be 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
General disorders
Death NOS
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
Other adverse events
| Measure |
Niraparib Treatment
n=9 participants at risk
Patients will be treated with individualized starting dose of Niraparib. Since each patient's dose will be individualized based on patients' weight and platelet count, arms/groups are combined.
Niraparib: The starting dose will be 300 mg niraparib (or modified according to patient weight and platelet count), taken orally once a day for each cycle of 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
3/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Cardiac disorders
Sinus bradycardia
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Cardiac disorders
Sinus tachycardia
|
44.4%
4/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Eye disorders
Blurred vision
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Gastrointestinal disorders
Constipation
|
66.7%
6/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Gastrointestinal disorders
Fecal incontinence
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Gastrointestinal disorders
Nausea
|
44.4%
4/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
General disorders
Edema limbs
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
General disorders
Fatigue
|
66.7%
6/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
General disorders
Gait disturbance
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
General disorders
Localized edema
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
General disorders
Malaise
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
3/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Investigations
Creatinine increased
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Investigations
Hemoglobin increased
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Investigations
Platelet count decreased
|
55.6%
5/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Investigations
Weight gain
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Nervous system disorders
Dysphasia
|
33.3%
3/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Nervous system disorders
Headache
|
44.4%
4/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Nervous system disorders
Memory impairment
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Nervous system disorders
Seizure
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Nervous system disorders
Tremor
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Psychiatric disorders
Confusion
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Renal and urinary disorders
Dysuria
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Renal and urinary disorders
Urinary incontinence
|
22.2%
2/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Renal and urinary disorders
Urinary retention
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
11.1%
1/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
3/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
|
Vascular disorders
Hypertension
|
44.4%
4/9 • Adverse events were collected for 17 months.
CTCAE 5.0
|
Additional Information
James Battiste, MD
University of Oklahoma Health Sciences Center
Phone: 405-271-8777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place