Trial Outcomes & Findings for A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL (NCT NCT02514083)
NCT ID: NCT02514083
Last Updated: 2024-09-19
Results Overview
Rate of complete response at 24 weeks or after 6 cycles. Response assessment was conducted according to the guidelines from the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Ibrutinib With Fludarabine in Patients With CLL or SLL
Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for duration of study. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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28
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Ibrutinib With Fludarabine in Patients With CLL or SLL
Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for duration of study. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
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|---|---|
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Overall Study
Adverse Event
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1
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Baseline Characteristics
A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL
Baseline characteristics by cohort
| Measure |
Ibrutinib With Fludarabine in Patients With CLL or SLL
n=29 Participants
Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for duration of study. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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14 Participants
n=5 Participants
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Age, Categorical
>=65 years
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15 Participants
n=5 Participants
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Age, Continuous
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62.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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19 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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29 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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28 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 24 weeksPopulation: Treatment-naive CLL or SLL patients
Rate of complete response at 24 weeks or after 6 cycles. Response assessment was conducted according to the guidelines from the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL).
Outcome measures
| Measure |
Ibrutinib With Fludarabine in Patients With CLL or SLL
n=28 Participants
Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for duration of study. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
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|---|---|
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Rate of Complete Response at 24 Weeks
Complete response
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6 Participants
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Rate of Complete Response at 24 Weeks
Partial response with or without lymphocytosis
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21 Participants
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Rate of Complete Response at 24 Weeks
Stable disease
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1 Participants
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PRIMARY outcome
Timeframe: 24 weeksRate of treatment discontinuation within the first 24 weeks or 6 cycles due to intolerable side effects from study therapy
Outcome measures
| Measure |
Ibrutinib With Fludarabine in Patients With CLL or SLL
n=29 Participants
Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for duration of study. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
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Rate of Treatment Discontinuation Within the First 24 Weeks
Treatment continued for 24+ weeks
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28 Participants
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Rate of Treatment Discontinuation Within the First 24 Weeks
Treatment discontinued within 24 weeks
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1 Participants
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Adverse Events
Ibrutinib With Fludarabine in Patients With CLL or SLL
Serious events: 14 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ibrutinib With Fludarabine in Patients With CLL or SLL
n=29 participants at risk
Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for days 1-28 from Cycle 1 up to Cycle 27. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
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|---|---|
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Investigations
Alanine aminotransferase increased
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Investigations
Aspartate aminotransferase increased
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6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Infections and infestations
Appendicitis
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Hepatobiliary disorders
Cholecystitis
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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General disorders
Death NOS
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Gastrointestinal disorders
Vomiting
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Cardiac disorders
Heart Failure
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Metabolism and nutrition disorders
Hyponatremia
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Infections and infestations
Lung infection
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6.9%
2/29 • Number of events 4 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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General disorders
Non-cardiac chest pain
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Cardiac disorders
Palpitations
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Gastrointestinal disorders
Pancreatitis
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Injury, poisoning and procedural complications
Post-operative Hemorrhage (Epistaxis)
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Infections and infestations
Sepsis
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Vascular disorders
Thromboembolic event
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Infections and infestations
Urinary tract infection
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Cardiac disorders
Ventricular arrhythmia
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulvar intraepithelial neoplasm
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
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13.8%
4/29 • Number of events 4 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative Breast Cancer
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
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3.4%
1/29 • Number of events 1 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Other adverse events
| Measure |
Ibrutinib With Fludarabine in Patients With CLL or SLL
n=29 participants at risk
Open-label study of ibrutinib and a short-course fludarabine in previously untreated participants with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Ibrutinib is administered orally, 420 mg daily for days 1-28 from Cycle 1 up to Cycle 27. Fludarabine dose is 25 mg/m2/day on days 1-5 of cycles 3 and 4.
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|---|---|
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Investigations
White blood cell decreased
|
65.5%
19/29 • Number of events 19 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Blood and lymphatic system disorders
Leukocytosis
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48.3%
14/29 • Number of events 14 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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Investigations
Platelet count decresaed
|
48.3%
14/29 • Number of events 14 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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|
Investigations
Neutrophil count decresaed
|
41.4%
12/29 • Number of events 12 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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|
Injury, poisoning and procedural complications
Bruising
|
65.5%
19/29 • Number of events 19 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Gastrointestinal disorders
Diarrhea
|
44.8%
13/29 • Number of events 13 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
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|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.9%
11/29 • Number of events 11 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
41.4%
12/29 • Number of events 12 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
General disorders
Fatigue
|
31.0%
9/29 • Number of events 9 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Vascular disorders
Hypertension
|
31.0%
9/29 • Number of events 9 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
General disorders
Pain
|
24.1%
7/29 • Number of events 7 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
General disorders
Peripheral edema
|
24.1%
7/29 • Number of events 7 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Skin and subcutaneous tissue disorders
Brittle nails
|
27.6%
8/29 • Number of events 8 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
20.7%
6/29 • Number of events 6 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Infections and infestations
Shingles
|
17.2%
5/29 • Number of events 5 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.2%
5/29 • Number of events 5 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
17.2%
5/29 • Number of events 5 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Nervous system disorders
Headache
|
13.8%
4/29 • Number of events 4 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Investigations
Alanine or aspartate aminotransferase increased
|
13.8%
4/29 • Number of events 4 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Infections and infestations
Lung infection
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Investigations
Lymphocyte count decreased
|
48.3%
14/29 • Number of events 14 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Investigations
Lymphocyte count increased
|
27.6%
8/29 • Number of events 8 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Gastrointestinal disorders
Nausea
|
17.2%
5/29 • Number of events 5 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Blood and lymphatic system disorders
Anemia
|
13.8%
4/29 • Number of events 4 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Investigations
Creatinine increased
|
13.8%
4/29 • Number of events 4 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
13.8%
4/29 • Number of events 4 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.8%
4/29 • Number of events 4 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
3/29 • Number of events 3 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Nervous system disorders
Dizziness
|
10.3%
3/29 • Number of events 3 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
3/29 • Number of events 3 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
General disorders
Flu like symptoms
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Blood and lymphatic system disorders
Hematoma
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Renal and urinary disorders
Hematuria
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Infections and infestations
Infections and infestations: other
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Infections and infestations
Productive cough
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Infections and infestations
Sinusitis
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Renal and urinary disorders
Urinary tract infection
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
|
Investigations
Weight gain
|
6.9%
2/29 • Number of events 2 • From treatment initiation until the last follow-up on study or death, whichever occurred first, assessed up to 4 years
The AE reporting period for this study begins when the participant takes the first dose of study drug and continues until the last follow-up on the study. Participants will continue on study until disease progression or intolerable side effects occur.
|
Additional Information
Inhye Ahn, M.D.
National Heart Lung and Blood Institute (NHLBI)
Phone: 301-827-1203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place