Trial Outcomes & Findings for Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation (NCT NCT05523440)
NCT ID: NCT05523440
Last Updated: 2026-06-03
Results Overview
To estimate the proportion of patients with objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
16 months, until early study termination
Results posted on
2026-06-03
Participant Flow
Nine subjects were accrued on the study at the University of Oklahoma and at the University of Virginia Arlington.
Of the 9 subjects accrued, there were 2 screenfails and 7 subjects who were eligible to start treatment. Of the 7 subjects, 4 were randomized to Arm 1 with niraparib only, and 3 were randomized to Arm 2 with niraparib and bevacizumab.
Participant milestones
| Measure |
Arm 1: Niraparib
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
Niraparib: Niraparib oral capsule.
|
Arm 2: Niraparib and Bevacizumab
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
Bevacizumab: Bevacizumab infusion.
Niraparib: Niraparib oral capsule.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Arm 1: Niraparib
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
Niraparib: Niraparib oral capsule.
|
Arm 2: Niraparib and Bevacizumab
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
Bevacizumab: Bevacizumab infusion.
Niraparib: Niraparib oral capsule.
|
|---|---|---|
|
Overall Study
Six subjects went off study due to disease progression and 1 was taken off due to study termination
|
4
|
3
|
Baseline Characteristics
Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation
Baseline characteristics by cohort
| Measure |
Arm 1: Niraparib
n=4 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
Niraparib: Niraparib oral capsule.
|
Arm 2: Niraparib and Bevacizumab
n=3 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
Bevacizumab: Bevacizumab infusion.
Niraparib: Niraparib oral capsule.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 Years
STANDARD_DEVIATION 8.4 • n=20 Participants
|
67.3 Years
STANDARD_DEVIATION 6.8 • n=20 Participants
|
65.4 Years
STANDARD_DEVIATION 7.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Prior Cancer Diagnosis
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 16 months, until early study terminationTo estimate the proportion of patients with objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.
Outcome measures
| Measure |
Arm 1: Niraparib
n=4 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
|
Arm 2: Niraparib and Bevacizumab
n=3 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
|
|---|---|---|
|
Proportion of Patients With Objective Response Rate With Recurrent Endometrial Cancer With Mutated ARID1A
|
0 Proportion of patients
|
0 Proportion of patients
|
PRIMARY outcome
Timeframe: 16 months, until early study terminationTo estimate the proportion of patients with objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.
Outcome measures
| Measure |
Arm 1: Niraparib
n=4 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
|
Arm 2: Niraparib and Bevacizumab
n=3 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
|
|---|---|---|
|
Proportion of Patients With Objective Response Rate With Recurrent Ovarian Cancer With Mutated ARID1A
|
0 Proportion of patients
|
0 Proportion of patients
|
SECONDARY outcome
Timeframe: 16 months, until early study terminationTo estimate the proportion of subjects with recurrent endometrial cancer or ovarian cancer with mutated ARID1A, who survive progression-free for at least 6 months, treated with each regimen.
Outcome measures
| Measure |
Arm 1: Niraparib
n=4 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
|
Arm 2: Niraparib and Bevacizumab
n=3 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
|
|---|---|---|
|
6 Month Duration of Response
|
0 Proportion
No responses documented. insufficient number of participants with events
|
0 Proportion
No responses documented. insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 16 months, until early study terminationTo estimate the progression-free survival (PFS) of subjects with recurrent endometrial cancer or ovarian cancer with mutated ARID1A treated with each regimen.
Outcome measures
| Measure |
Arm 1: Niraparib
n=4 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
|
Arm 2: Niraparib and Bevacizumab
n=3 Participants
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
|
|---|---|---|
|
Progression Free Survival
|
2.87 Months
Interval 1.62 to
The lower 95% CI never crosses the 50% threshold. insufficient number of participants with events. insufficient number of participants with events
|
NA Months
Never crosses the 50% threshold for median calculation (only one patient experienced an event). insufficient number of participants with events. insufficient number of participants with events
|
Adverse Events
Arm 1: Niraparib
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Arm 2: Niraparib and Bevacizumab
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1: Niraparib
n=4 participants at risk
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
|
Arm 2: Niraparib and Bevacizumab
n=3 participants at risk
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
|
|---|---|---|
|
Cardiac disorders
Restrictive Cardiomyopathy
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
Flank Pain R
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Infections and infestations
kidney infection
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Investigations
thrombocytopenia
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
Other adverse events
| Measure |
Arm 1: Niraparib
n=4 participants at risk
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
|
Arm 2: Niraparib and Bevacizumab
n=3 participants at risk
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).
|
|---|---|---|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Metabolism and nutrition disorders
HYPOPOSPHATEMIA
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Metabolism and nutrition disorders
WEIGHT LOSS
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS WORSENING-KNEES
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
PAIN; RIGHT KNEE
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR HEMORRHAGE, INT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Nervous system disorders
HEADACHE (LEFT SIDED), INT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Nervous system disorders
HEADACHE, INT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Nervous system disorders
HEADACHES
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Nervous system disorders
TREMOR, INT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Nervous system disorders
TREMORS
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Psychiatric disorders
CONFUSION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/4 • 1 year and 7 months
|
66.7%
2/3 • 1 year and 7 months
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
RENAL CALCULI
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
RIGHT NEPHROSTOMY TUBE EXCHANGE
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
RIGHT NEPHROSTOMY TUBE PLACEMENT AND STENT REMOVAL
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
URETHRAL STENT PLACEMENT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
URETHRAL STENT PLACEMENT, RIGHT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
URINARY URGENCY
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/4 • 1 year and 7 months
|
66.7%
2/3 • 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Skin and subcutaneous tissue disorders
CONTACT DERMATITIS
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Surgical and medical procedures
ESOPHAGOGASTRODUODENOSCOPY
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Surgical and medical procedures
LEFT STENT PLACEMENT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Surgical and medical procedures
RIGHT STENT REPLACEMENT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Vascular disorders
HYPOTENSION, INT
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Vascular disorders
MURAL LV THROMBUS
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
LEFT PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Renal and urinary disorders
URINARY RETENTION
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
PLATELET COUNT DECREASED
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/4 • 1 year and 7 months
|
66.7%
2/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/4 • 1 year and 7 months
|
66.7%
2/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
ESOPHAGEAL STENOSIS
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
ORAL DYSESTHESIA
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
General disorders
PAIN WORSENING
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Immune system disorders
NEUTROPHIL COUNT DECREASED
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Investigations
CARDIAC TROPONIN T INCREASED
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Investigations
WEIGHT LOSS
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.00%
0/4 • 1 year and 7 months
|
33.3%
1/3 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
25.0%
1/4 • 1 year and 7 months
|
66.7%
2/3 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
50.0%
2/4 • 1 year and 7 months
|
100.0%
3/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
MUCOSITIS ORAL, INT
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
NAUSEA
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Gastrointestinal disorders
VOMITING
|
25.0%
1/4 • 1 year and 7 months
|
66.7%
2/3 • 1 year and 7 months
|
|
General disorders
FATIGUE
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
General disorders
FLU LIKE SYMPTOMS
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Investigations
THROMBOCYTOPENIA
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Metabolism and nutrition disorders
ANOREXIA
|
25.0%
1/4 • 1 year and 7 months
|
66.7%
2/3 • 1 year and 7 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
|
Nervous system disorders
PARESTHESIA
|
25.0%
1/4 • 1 year and 7 months
|
0.00%
0/3 • 1 year and 7 months
|
Additional Information
Lauren Dockery
University of Oklahoma Health Sciences Center
Phone: 4052718777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place