Trial Outcomes & Findings for Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia (NCT NCT01848145)
NCT ID: NCT01848145
Last Updated: 2017-06-06
Results Overview
Defined as percent of patients who are able to complete the Day 8 (2000 mg IV Ofatumumab) infusion within 15 minutes of the planned 2-hour treatment goal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
At Week 2, Day 1 of therapy
Results posted on
2017-06-06
Participant Flow
Between July 2013 and June 2015, 34 subjects with at least one prior therapy for Chronic Lymphocytic Leukemia (CLL) were enrolled at 5 investigational sites in the U.S.
Participant milestones
| Measure |
Ofatumumab Accelerated Infusion
Ofatumumab administered by intravenous (IV) infusion. .
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Infusion 1: Week 1, Day 1 - 226 Minutes
STARTED
|
34
|
|
Infusion 1: Week 1, Day 1 - 226 Minutes
Completed Within 15min of Infusion Time
|
1
|
|
Infusion 1: Week 1, Day 1 - 226 Minutes
COMPLETED
|
33
|
|
Infusion 1: Week 1, Day 1 - 226 Minutes
NOT COMPLETED
|
1
|
|
Infusion 2: Week 1, Day 3 - 167 Minutes
STARTED
|
33
|
|
Infusion 2: Week 1, Day 3 - 167 Minutes
Completed Within 15min of Infusion Time
|
24
|
|
Infusion 2: Week 1, Day 3 - 167 Minutes
COMPLETED
|
31
|
|
Infusion 2: Week 1, Day 3 - 167 Minutes
NOT COMPLETED
|
2
|
|
Infusion 3: Week 2, Day 1 - 120 Minutes
STARTED
|
31
|
|
Infusion 3: Week 2, Day 1 - 120 Minutes
Completed Within 15min of Infusion Time
|
26
|
|
Infusion 3: Week 2, Day 1 - 120 Minutes
COMPLETED
|
30
|
|
Infusion 3: Week 2, Day 1 - 120 Minutes
NOT COMPLETED
|
1
|
|
Subsequent Infusions: Weeks 3-8
STARTED
|
30
|
|
Subsequent Infusions: Weeks 3-8
COMPLETED
|
20
|
|
Subsequent Infusions: Weeks 3-8
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Ofatumumab Accelerated Infusion
Ofatumumab administered by intravenous (IV) infusion. .
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Infusion 1: Week 1, Day 1 - 226 Minutes
Adverse Event
|
1
|
|
Infusion 2: Week 1, Day 3 - 167 Minutes
Adverse Event
|
1
|
|
Infusion 2: Week 1, Day 3 - 167 Minutes
Disease Progression
|
1
|
|
Infusion 3: Week 2, Day 1 - 120 Minutes
Adverse Event
|
1
|
|
Subsequent Infusions: Weeks 3-8
Disease Progression
|
6
|
|
Subsequent Infusions: Weeks 3-8
Withdrawal by Subject
|
3
|
|
Subsequent Infusions: Weeks 3-8
Death
|
1
|
Baseline Characteristics
Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Ofatumumab Accelerated Infusion
n=34 Participants
Ofatumumab administered by intravenous (IV) infusion. The goal is to complete infusion #3 within 120 minutes (+/- 15 minutes).
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Age, Customized
|
70 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
33 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At Week 2, Day 1 of therapyPopulation: Patients who completed Infusion #3 within the 2 hour treatment goal.
Defined as percent of patients who are able to complete the Day 8 (2000 mg IV Ofatumumab) infusion within 15 minutes of the planned 2-hour treatment goal.
Outcome measures
| Measure |
Ofatumumab Accelerated Infusion
n=31 Participants
Ofatumumab administered by intravenous (IV) infusion.
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Percent of Patients Who Complete an Accelerated Infusion Regimen Within 15 Minutes of the Planned 2-hour Treatment.
|
84 percentage of participants
|
SECONDARY outcome
Timeframe: Week 1 - Days 1 and 3, and Week 2, Day 1Population: Includes all treated participants. 1 participant discontinued treatment after Infusion # 1 but prior to Infusion #2. 2 participants discontinued treatment after Infusion #2 but prior to Infusion #3
Defined as the actual mean infusion times, in minutes, for patients to complete a schedule of 3 infusions with the goal of completing Infusion #3 within 15 minutes of the planned 2-hour treatment time.
Outcome measures
| Measure |
Ofatumumab Accelerated Infusion
n=34 Participants
Ofatumumab administered by intravenous (IV) infusion.
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab
Infusion #1: planned 226 minutes
|
316 minutes
Interval 156.0 to 475.0
|
|
Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab
Infusion #2: planned 167 minutes
|
185 minutes
Interval 130.0 to 285.0
|
|
Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab
Infusion #3: planned 120 minutes
|
126 minutes
Interval 78.0 to 246.0
|
SECONDARY outcome
Timeframe: At weeks 12 and 28Population: All evaluable patients. 3 patients discontinued prior to assessment.
Defined as the percent of patients having a complete or partial response (CR or PR) assessed by International Workshop on CLL Working Group (IWCLLWG) Diagnostic Criteria (Hallek et al., 2008). CR = (a) Peripheral blood lymphocytes below 4000/µl; (b) Absence of significant lymphadenopathy by physical exam or radiographic scans (c) No hepatomegaly or splenomegaly; (d) Absence of constitutional symptoms; and blood counts above specified values. PR = (a) Decreased blood lymphocytes by 50% or more from the value prior to therapy;(b) No increase in any lymph node, and no new enlarged lymph node. Progressive Disease (PD) = An increase in 50% or more in greatest determined diameter of any previous site. Stable Disease (SD) = No evidence of CR or PR and no evidence of progressive disease.
Outcome measures
| Measure |
Ofatumumab Accelerated Infusion
n=31 Participants
Ofatumumab administered by intravenous (IV) infusion.
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Overall Response Rate (ORR)
ORR
|
19 percentage of patients
|
|
Overall Response Rate (ORR)
PR
|
19 percentage of patients
|
|
Overall Response Rate (ORR)
SD
|
71 percentage of patients
|
|
Overall Response Rate (ORR)
PD
|
10 percentage of patients
|
SECONDARY outcome
Timeframe: For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.Population: All patients who received at least 1 dose of protocol treatment.
Defined as the time from first treatment until objective tumor progression or death from any cause.
Outcome measures
| Measure |
Ofatumumab Accelerated Infusion
n=34 Participants
Ofatumumab administered by intravenous (IV) infusion.
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Progression Free Survival
|
9.25 months
Interval 7.39 to 11.83
|
SECONDARY outcome
Timeframe: For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.Defined as the time from first treatment until death from any cause.
Outcome measures
| Measure |
Ofatumumab Accelerated Infusion
n=34 Participants
Ofatumumab administered by intravenous (IV) infusion.
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Overall Survival
|
NA months
Interval 29.73 to
At a median follow-up of approximately 24 months overall survival has not been reached.
|
SECONDARY outcome
Timeframe: up to 28 weeksPatients who received at least 1 dose of protocol treatment either Infusion #1 (300 mg), Infusion #2 (1000 mg) or Infusion #3 (2000 mg) are included in the assessment.
Outcome measures
| Measure |
Ofatumumab Accelerated Infusion
n=34 Participants
Ofatumumab administered by intravenous (IV) infusion.
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.
Infusion #1: 300 mg
|
21 participants
|
|
Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.
Infusion #2: 1000 mg
|
4 participants
|
|
Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.
Infusion #3: 2000 mg
|
1 participants
|
Adverse Events
Ofatumumab Accelerated Infusion
Serious events: 9 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ofatumumab Accelerated Infusion
n=34 participants at risk
Ofatumumab administered by intravenous (IV) infusion. The goal infusion time at Infusion #3 is 120 minutes.
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Infections and infestations
Pneumonia
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Infections and infestations
Bacterial Sepsis
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Infections and infestations
Influenza
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Infections and infestations
Varicella
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Cardiac disorders
Cardiac Arrest
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Nervous system disorders
Loss of Consciousness
|
2.9%
1/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
Other adverse events
| Measure |
Ofatumumab Accelerated Infusion
n=34 participants at risk
Ofatumumab administered by intravenous (IV) infusion. The goal infusion time at Infusion #3 is 120 minutes.
* Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.
* Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.
* Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)
* Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28.
|
|---|---|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
44.1%
15/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.3%
12/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.8%
4/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.6%
7/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
26.5%
9/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.8%
4/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
General disorders
Fatigue
|
29.4%
10/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
General disorders
Pyrexia
|
20.6%
7/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
General disorders
Chills
|
17.6%
6/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
General disorders
Asthenia
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
General disorders
Influenza-Like Illness
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
General disorders
Oedema
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
General disorders
Oedema Peripheral
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
23.5%
8/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.8%
4/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Hypoaethesia Oral
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.6%
7/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
4/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Vascular disorders
Flushing
|
14.7%
5/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Investigations
Alanine Aminotransferase Increased
|
11.8%
4/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.7%
5/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.8%
4/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Psychiatric disorders
Depression
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
11.8%
4/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Nervous system disorders
Syncope
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Nervous system disorders
Tremor
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.8%
4/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.8%
3/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Infections and infestations
Urinary Tract Infection
|
14.7%
5/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Conjunctivitis
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
|
Immune system disorders
Seasonal Allergy
|
5.9%
2/34 • For 28 weeks during treatment then every 3 months for 2 years, and every 6 months thereafter until disease progression.
All patients who received at least one dose of protocol treatment are included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER