Trial Outcomes & Findings for Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study) (NCT NCT04738292)
NCT ID: NCT04738292
Last Updated: 2024-05-03
Results Overview
Best overall response of complete response (CR) or partial response (PR), as per RECIST 1.1. Point and 95% interval estimate of ORR will be evaluated accounting for possibility of early futility stopping.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
up to 17 months
Results posted on
2024-05-03
Participant Flow
Participants were recruited from the UW Hospital and Clinics and the Medical College of Wisconsin between October 2021 and January 2023.
Participant milestones
| Measure |
Onapristone In Combination With Fulvestrant
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Onapristone In Combination With Fulvestrant
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
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|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
Baseline characteristics by cohort
| Measure |
Onapristone In Combination With Fulvestrant
n=11 Participants
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
|
|---|---|
|
Age, Customized
30 to 39 years old
|
1 Participants
n=99 Participants
|
|
Age, Customized
40 to 49 years old
|
1 Participants
n=99 Participants
|
|
Age, Customized
50 to 59 years old
|
3 Participants
n=99 Participants
|
|
Age, Customized
60 to 69 years old
|
5 Participants
n=99 Participants
|
|
Age, Customized
70 to 79 years old
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 17 monthsBest overall response of complete response (CR) or partial response (PR), as per RECIST 1.1. Point and 95% interval estimate of ORR will be evaluated accounting for possibility of early futility stopping.
Outcome measures
| Measure |
Onapristone In Combination With Fulvestrant
n=11 Participants
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
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|---|---|
|
Number of Participants With Objective Response (ORR)
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 17 monthsTime from date of enrollment to the date of first documented disease progression or death due to any cause. PFS will be described with Kaplan-Meier (KM) Curve and its pointwise asymptotic 95% confidence bounds. Median PFS if reached will be extracted from this KM estimator.
Outcome measures
| Measure |
Onapristone In Combination With Fulvestrant
n=11 Participants
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
|
|---|---|
|
Number of Participants Experiencing Progression Free Survival (PFS)
1 year PFS
|
0 Participants
|
|
Number of Participants Experiencing Progression Free Survival (PFS)
17 month PFS
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 17 monthsBest overall response of CR, PR or stable disease (SD) lasting for ≥ 24 weeks, as per RECIST 1.1. DCR will be estimated with relative frequency and exact two-sided 95% binomial confidence interval.
Outcome measures
| Measure |
Onapristone In Combination With Fulvestrant
n=11 Participants
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
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|---|---|
|
Number of Participants With Disease Control (DCR)
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 17 monthsPopulation: Time to response could not be calculated as there was not a response to treatment within the study time points.
Time from registration to first documented response (CR or PR) will be evaluated with a cumulative incidence where death will be as a competing risk to response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 17 monthsPopulation: Duration of Response could not be calculated because there was no response to treatment within the study time points.
Time between the first date of documented response to progression or death due to breast cancer. Duration of response will be assessed for a subgroup of subjects with observed response. The date of response will be denoted as time zero and time to progression or death will be evaluated with KM curve and 95% confidence interval (CI). Median time to response will be extracted from this KM curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 17 monthsType, frequency and severity of adverse events and laboratory abnormalities (according to CTCAE version 5.0) will be summarized with descriptive frequency tables. See Adverse Events Section for detailed summary.
Outcome measures
| Measure |
Onapristone In Combination With Fulvestrant
n=11 Participants
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
|
|---|---|
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Incidence of Treatment-Related Adverse Events
Participants Experiencing Grade 1 Adverse Events
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6 Participants
|
|
Incidence of Treatment-Related Adverse Events
Participants Experiencing Grade 2 Adverse Events
|
1 Participants
|
|
Incidence of Treatment-Related Adverse Events
Participants Experiencing Grade 3 Adverse Events
|
1 Participants
|
Adverse Events
Onapristone In Combination With Fulvestrant
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Onapristone In Combination With Fulvestrant
n=11 participants at risk
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
|
|---|---|
|
General disorders
Pain
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Infections and infestations
Lung Infection
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
Other adverse events
| Measure |
Onapristone In Combination With Fulvestrant
n=11 participants at risk
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days.
There will be no breaks between dosing cycles.
Onapristone: Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
Fulvestrant: Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.
|
|---|---|
|
General disorders
Fatigue
|
36.4%
4/11 • Number of events 5 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
General disorders
Non-cardiac chest pain
|
27.3%
3/11 • Number of events 3 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
General disorders
Chills
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
General disorders
Facial pain
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
General disorders
Fever
|
9.1%
1/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
General disorders
Injection site reaction
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
36.4%
4/11 • Number of events 4 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
36.4%
4/11 • Number of events 6 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Gastrointestinal disorders
Constipation
|
45.5%
5/11 • Number of events 5 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 5 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Number of events 4 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Infections and infestations
Infections and infestations - Other, specify
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Infections and infestations
Urinary tract infection
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Injury, poisoning and procedural complications
Fracture
|
9.1%
1/11 • Number of events 3 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.4%
4/11 • Number of events 4 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Cardiac disorders
Sinus tachycardia
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Ear and labyrinth disorders
Vertigo
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Eye disorders
Blurred vision
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Eye disorders
Flashing lights
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Renal and urinary disorders
Urinary frequency
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Renal and urinary disorders
Urinary urgency
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Reproductive system and breast disorders
Breast pain
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
General disorders
Gait Disturbance
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
General disorders
Flu like symptoms
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Blood and lymphatic system disorders
Lymph node pain
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Gastrointestinal disorders
Abdominal pain
|
36.4%
4/11 • Number of events 4 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Gastrointestinal disorders
Belching
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Nervous system disorders
Paresthesia
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Nervous system disorders
Hypersomnia
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Nervous system disorders
Memory impairment
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Psychiatric disorders
Delirium
|
9.1%
1/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Renal and urinary disorders
Urinary incontinence
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Vascular disorders
Hot flashes
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Vascular disorders
Hypertension
|
36.4%
4/11 • Number of events 8 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Vascular disorders
Lymphedema
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
2/11 • Number of events 2 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.3%
3/11 • Number of events 3 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Investigations
Alanine aminotransferase increased
|
27.3%
3/11 • Number of events 7 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Investigations
Alkaline phosphatase increased
|
27.3%
3/11 • Number of events 3 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Investigations
Aspartate aminotransferase increased
|
45.5%
5/11 • Number of events 7 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Investigations
Blood bilirubin increased
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Investigations
Lymphocyte count decreased
|
27.3%
3/11 • Number of events 4 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Investigations
White blood cell decreased
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Number of events 1 • from consent to 30 days following last dose of study drug (up to approximately 17 months)
AEs may be spontaneously reported by the patient and/or in response to an open question from study personnel or revealed by observation, physical examination or other diagnostic procedures
|
Additional Information
Sailaja Kamaraju, MD, MS
Froedtert / Medical College of Wisconsin
Phone: 414-805-4600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place