Trial Outcomes & Findings for Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium (NCT NCT03476798)
NCT ID: NCT03476798
Last Updated: 2024-02-15
Results Overview
To estimate the proportion of pts treated w/bevacizumab who are progression-free. Progression for measurable disease per RECIST v1.1. Progression for pts with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
COMPLETED
PHASE2
49 participants
6 months
2024-02-15
Participant Flow
Participants were recruited at 3 cancer centers from June 2018 to Nov 2019. The first patient was enrolled on July 2, 2018 and the last patient was enrolled on November 8, 2019
Of 49 enrolled participants, 33 met inclusion criteria and assign to the single arm treatment. Among 33 participants started treatment, 28 were evaluable for statistical analysis.
Participant milestones
| Measure |
Bevacizumab + Rucaparib
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Bevacizumab + Rucaparib
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Protocol Violation
|
2
|
Baseline Characteristics
Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium
Baseline characteristics by cohort
| Measure |
Bevacizumab + Rucaparib
n=33 Participants
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Patients who met criteria for evaluability: Evaluable patients will be defined as patients with measurable and/or evaluable lesions who received at least cycle 1 doses of study treatment (one dose of IV bevacizumab and 21 days of rucaprib, PO, BID) and complete the first post-treatment CT or MRI for tumor assessment.
To estimate the proportion of pts treated w/bevacizumab who are progression-free. Progression for measurable disease per RECIST v1.1. Progression for pts with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
Outcome measures
| Measure |
Bevacizumab + Rucaparib
n=28 Participants
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Proportion of Patients Who Are Progression-free at 6 Months
|
0.29 Proportion of patients
Interval 0.13 to 0.47
|
SECONDARY outcome
Timeframe: up to 2 yearsTo estimate the proportion of patients treated with bevacizumab and rucaparib who have objective tumor response (complete or partial)
Outcome measures
| Measure |
Bevacizumab + Rucaparib
n=28 Participants
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Proportion of Patients Who Had Objective Tumor Response
|
0.14 Proportion of patients
Interval 0.04 to 0.33
|
SECONDARY outcome
Timeframe: up to 2 yearPopulation: All patients who received treatment
To determine the nature and degree of toxicity in combination of rucaparib and bevacizumab (Adverse Event Grade 3 and higher).
Outcome measures
| Measure |
Bevacizumab + Rucaparib
n=33 Participants
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Number of Patients Who Experience Toxicity
|
22 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsTo estimate the median overall survival of patients treated with combination rucaparib and bevacizumab.
Outcome measures
| Measure |
Bevacizumab + Rucaparib
n=28 Participants
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Median Overall Survival
|
10.12 Months
Interval 7.04 to 15.17
|
SECONDARY outcome
Timeframe: up to 2 yearsTo estimate the progression-free survival (PFS) of patients with persistent or recurrent cervical or endometrial cancer treated with combination rucaparib and bevacizumab Progression for measurable disease per RECIST v1.1 Progression for patients with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
Outcome measures
| Measure |
Bevacizumab + Rucaparib
n=28 Participants
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Median Progression-free Survival Time
|
3.83 Months
Interval 2.51 to 5.72
|
Adverse Events
Bevacizumab + Rucaparib
Serious adverse events
| Measure |
Bevacizumab + Rucaparib
n=33 participants at risk
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
2/33 • up to 34 months
|
|
Gastrointestinal disorders
Nausea
|
12.1%
4/33 • up to 34 months
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
4/33 • up to 34 months
|
|
General disorders
Fatigue
|
6.1%
2/33 • up to 34 months
|
|
Infections and infestations
Sepsis
|
6.1%
2/33 • up to 34 months
|
|
Infections and infestations
Urinary tract infection
|
6.1%
2/33 • up to 34 months
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
3/33 • up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
2/33 • up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.1%
2/33 • up to 34 months
|
Other adverse events
| Measure |
Bevacizumab + Rucaparib
n=33 participants at risk
Rucaparib: Rucaparib 600mg PO BID daily
Bevacizumab: Bevacizumab 15mg/kg IV on day 1 of each cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
24.2%
8/33 • up to 34 months
|
|
Cardiac disorders
Sinus tachycardia
|
6.1%
2/33 • up to 34 months
|
|
Eye disorders
Blurred vision
|
9.1%
3/33 • up to 34 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.1%
4/33 • up to 34 months
|
|
Gastrointestinal disorders
Constipation
|
24.2%
8/33 • up to 34 months
|
|
Gastrointestinal disorders
Diarrhea
|
48.5%
16/33 • up to 34 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.1%
4/33 • up to 34 months
|
|
Gastrointestinal disorders
Mucositis oral
|
18.2%
6/33 • up to 34 months
|
|
Gastrointestinal disorders
Nausea
|
63.6%
21/33 • up to 34 months
|
|
Gastrointestinal disorders
Vomiting
|
48.5%
16/33 • up to 34 months
|
|
General disorders
Edema limbs
|
6.1%
2/33 • up to 34 months
|
|
General disorders
Fatigue
|
57.6%
19/33 • up to 34 months
|
|
General disorders
Fever
|
12.1%
4/33 • up to 34 months
|
|
General disorders
Localized edema
|
24.2%
8/33 • up to 34 months
|
|
General disorders
Pain
|
15.2%
5/33 • up to 34 months
|
|
Infections and infestations
Otitis externa
|
6.1%
2/33 • up to 34 months
|
|
Infections and infestations
Sinusitis
|
9.1%
3/33 • up to 34 months
|
|
Infections and infestations
Urinary tract infection
|
27.3%
9/33 • up to 34 months
|
|
Injury, poisoning and procedural complications
Bruising
|
15.2%
5/33 • up to 34 months
|
|
Investigations
Alanine aminotransferase increased
|
15.2%
5/33 • up to 34 months
|
|
Investigations
Alkaline phosphatase increased
|
9.1%
3/33 • up to 34 months
|
|
Investigations
Aspartate aminotransferase increased
|
15.2%
5/33 • up to 34 months
|
|
Investigations
Blood bilirubin increased
|
15.2%
5/33 • up to 34 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.1%
2/33 • up to 34 months
|
|
Investigations
Cholesterol high
|
9.1%
3/33 • up to 34 months
|
|
Investigations
Creatinine increased
|
18.2%
6/33 • up to 34 months
|
|
Investigations
Platelet count decreased
|
21.2%
7/33 • up to 34 months
|
|
Investigations
Weight loss
|
21.2%
7/33 • up to 34 months
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
9/33 • up to 34 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.1%
2/33 • up to 34 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.1%
2/33 • up to 34 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
3/33 • up to 34 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.1%
2/33 • up to 34 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
3/33 • up to 34 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.1%
2/33 • up to 34 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.1%
2/33 • up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
6/33 • up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
4/33 • up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.1%
2/33 • up to 34 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.2%
8/33 • up to 34 months
|
|
Nervous system disorders
Dizziness
|
33.3%
11/33 • up to 34 months
|
|
Nervous system disorders
Dysgeusia
|
24.2%
8/33 • up to 34 months
|
|
Nervous system disorders
Headache
|
45.5%
15/33 • up to 34 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
3/33 • up to 34 months
|
|
Psychiatric disorders
Agitation
|
21.2%
7/33 • up to 34 months
|
|
Psychiatric disorders
Anxiety
|
12.1%
4/33 • up to 34 months
|
|
Renal and urinary disorders
Hematuria
|
12.1%
4/33 • up to 34 months
|
|
Renal and urinary disorders
Proteinuria
|
30.3%
10/33 • up to 34 months
|
|
Renal and urinary disorders
Urinary frequency
|
12.1%
4/33 • up to 34 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
9.1%
3/33 • up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
11/33 • up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.2%
8/33 • up to 34 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.2%
7/33 • up to 34 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
3/33 • up to 34 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
27.3%
9/33 • up to 34 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.2%
5/33 • up to 34 months
|
|
Vascular disorders
Hot flashes
|
15.2%
5/33 • up to 34 months
|
|
Vascular disorders
Hypertension
|
57.6%
19/33 • up to 34 months
|
|
Vascular disorders
Hypotension
|
6.1%
2/33 • up to 34 months
|
|
Vascular disorders
Thromboembolic event
|
6.1%
2/33 • up to 34 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place