Trial Outcomes & Findings for Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer (NCT NCT01560923)
NCT ID: NCT01560923
Last Updated: 2020-04-03
Results Overview
Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Increase in number of ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
14 Weeks from First Leukapheresis
Results posted on
2020-04-03
Participant Flow
One patient withdrew or refused to participate after receiving protocol therapy
Participant milestones
| Measure |
Sipuleucel-T + Placebo
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
Sipuleucel-T + Oral Indoximod
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Control (Placebo) Arm
n=24 Participants
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
Treatment
n=22 Participants
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 14 Weeks from First LeukapheresisAssess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Increase in number of ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm.
Outcome measures
| Measure |
Sipuleucel-T + Placebo
n=24 Participants
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
Sipuleucel-T + Oral Indoximod
n=22 Participants
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
|---|---|---|
|
Immune Response to Sipuleucel-T
|
29.6 Spots per ml
Interval 4.86 to 180.37
|
25.45 Spots per ml
Interval 2.92 to 222.12
|
SECONDARY outcome
Timeframe: 6 MonthsProgression free survival (PFS) is a composite endpoint defined as disease progression in bone or soft tissues, PSA progression, worsening pain, or death. PFS will be measured in months from the time of study enrollment until the date of disease progression. Progression is evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \[Eur J Ca 45:228-247, 2009\]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.
Outcome measures
| Measure |
Sipuleucel-T + Placebo
n=24 Participants
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
Sipuleucel-T + Oral Indoximod
n=22 Participants
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
|---|---|---|
|
Number of Participants With Progression Free Survival at 6 Months
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 4 weeksrate as defined by Prostate Cancer Working Group -2 (PCWG2). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST)(version 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesion. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Sipuleucel-T + Placebo
n=24 Participants
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
Sipuleucel-T + Oral Indoximod
n=22 Participants
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
|---|---|---|
|
Objective Response Rate
Partial response (PR)
|
1 Participants
|
0 Participants
|
|
Objective Response Rate
Not Evaluable
|
0 Participants
|
2 Participants
|
|
Objective Response Rate
Stable Disease (SD)
|
5 Participants
|
11 Participants
|
|
Objective Response Rate
Baseline
|
3 Participants
|
1 Participants
|
|
Objective Response Rate
Non-CR/Non-PD
|
1 Participants
|
1 Participants
|
|
Objective Response Rate
Progressive Disease (PD)
|
12 Participants
|
7 Participants
|
|
Objective Response Rate
Not Assessed
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsTo evaluate 2 year overall survival
Outcome measures
| Measure |
Sipuleucel-T + Placebo
n=24 Participants
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
Sipuleucel-T + Oral Indoximod
n=22 Participants
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
|---|---|---|
|
Overall Survival
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6 Monthsmeasured by the performance status with scale of 0-5 0 being 'normal activity' and 5 'being dead'
Outcome measures
| Measure |
Sipuleucel-T + Placebo
n=24 Participants
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
Sipuleucel-T + Oral Indoximod
n=22 Participants
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
|---|---|---|
|
Quality of Life Scale Results
Baseline Performance Status Score · 0 - Normal activity, Fully active
|
19 Participants
|
15 Participants
|
|
Quality of Life Scale Results
Baseline Performance Status Score · 1- Symptoms but ambulatory
|
5 Participants
|
7 Participants
|
|
Quality of Life Scale Results
Baseline Performance Status Score · No Data
|
0 Participants
|
0 Participants
|
|
Quality of Life Scale Results
Post Treatment performance Status Score · 0 - Normal activity, Fully active
|
7 Participants
|
9 Participants
|
|
Quality of Life Scale Results
Post Treatment performance Status Score · 1- Symptoms but ambulatory
|
10 Participants
|
3 Participants
|
|
Quality of Life Scale Results
Post Treatment performance Status Score · No Data
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 14 Weeks from First LeukapheresisAssess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Antibodies to PA2024 is measured by ELISA. The ratio of antibodies to ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm.
Outcome measures
| Measure |
Sipuleucel-T + Placebo
n=24 Participants
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
Sipuleucel-T + Oral Indoximod
n=22 Participants
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
|---|---|---|
|
Ratio of Antibodies to PA2024
PA2024 IGG ratio (wk14/baseline)
|
13.05 Ratio
Interval 5.05 to 33.72
|
9.19 Ratio
Interval 3.04 to 27.8
|
|
Ratio of Antibodies to PA2024
PA2024 IGGIGM ratio (wk14/baseline)
|
104.39 Ratio
Interval 33.88 to 321.66
|
111.43 Ratio
Interval 35.49 to 349.89
|
Adverse Events
Sipuleucel-T + Indoximod
Serious events: 2 serious events
Other events: 20 other events
Deaths: 5 deaths
Sipuleucel-T + Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Sipuleucel-T + Indoximod
n=22 participants at risk
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
Sipuleucel-T + Placebo
n=24 participants at risk
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract obstruction
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
Other adverse events
| Measure |
Sipuleucel-T + Indoximod
n=22 participants at risk
Oral Indoximod will be self-administered by mouth twice daily (1200 mg) for 6 months starting after the last (3rd) infusion of sipuleucel-T. Indoximod is a sterile tan powder compounded in capsule form of 200 mg.
Indoximod: Given twice daily (1200 mg total) by mouth for 6 months.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
|
Sipuleucel-T + Placebo
n=24 participants at risk
Placebo is identical-looking to Indoximod and provided in the same manner.
Sipuleucel-T: Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
Placebo: Given in same manner as Indoximod; 1200 mg per day by mouth.
|
|---|---|---|
|
Blood and lymphatic system disorders
Positive ANA panel 1:320
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Blood and lymphatic system disorders
Anemia
|
4.5%
1/22 • Number of events 1 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Blood and lymphatic system disorders
Lymph node pain (bilateral inguinal)
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Cardiac disorders
Atrial flutter
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Ear and labyrinth disorders
Middle ear effusion
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Eye disorders
Blurred vision
|
0.00%
0/22 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
Eye disorders
Watering eyes
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Abdominal distension
|
4.5%
1/22 • Number of events 1 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
4/22 • Number of events 5 • 28 days
|
0.00%
0/24 • 28 days
|
|
Gastrointestinal disorders
Bloating
|
9.1%
2/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
Gastrointestinal disorders
Constipation
|
18.2%
4/22 • Number of events 6 • 28 days
|
16.7%
4/24 • Number of events 5 • 28 days
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
2/22 • Number of events 3 • 28 days
|
25.0%
6/24 • Number of events 10 • 28 days
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • Number of events 1 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
Gastrointestinal disorders
Increased appetite
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22 • Number of events 4 • 28 days
|
16.7%
4/24 • Number of events 5 • 28 days
|
|
Gastrointestinal disorders
Mouth sores
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Number of events 3 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Gastrointestinal disorders
Rectal Mucus
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
4.5%
1/22 • Number of events 2 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Gastrointestinal disorders
Teeth discomfort
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Gastrointestinal disorders
GERD
|
4.5%
1/22 • Number of events 3 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
General disorders
Chills
|
4.5%
1/22 • Number of events 1 • 28 days
|
12.5%
3/24 • Number of events 4 • 28 days
|
|
General disorders
TMJ pain
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
General disorders
Fatique
|
40.9%
9/22 • Number of events 11 • 28 days
|
29.2%
7/24 • Number of events 10 • 28 days
|
|
General disorders
Fever
|
13.6%
3/22 • Number of events 3 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
General disorders
Flu like symptoms
|
4.5%
1/22 • Number of events 1 • 28 days
|
12.5%
3/24 • Number of events 3 • 28 days
|
|
General disorders
Other general disorders -Reflux
|
0.00%
0/22 • 28 days
|
8.3%
2/24 • Number of events 3 • 28 days
|
|
General disorders
Pain
|
4.5%
1/22 • Number of events 1 • 28 days
|
20.8%
5/24 • Number of events 13 • 28 days
|
|
General disorders
Edema
|
9.1%
2/22 • Number of events 2 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
General disorders
Chest pressure
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Infections and infestations
Toe fungal infection
|
4.5%
1/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
Infections and infestations
Toxoplasma exposure
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Infections and infestations
Sepsis
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Infections and infestations
sinusitis
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Infections and infestations
Skin infection
|
4.5%
1/22 • Number of events 1 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
2/22 • Number of events 2 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Infections and infestations
right leg infection
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 2 • 28 days
|
|
Infections and infestations
Papular rash to nose and left neck
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Injury, poisoning and procedural complications
Left fibula fracture
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 2 • 28 days
|
|
Injury, poisoning and procedural complications
Issues with return IV
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Injury, poisoning and procedural complications
Bleeding to cather
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 2 • 28 days
|
|
Investigations
Elevated alkaline phosphatase
|
4.5%
1/22 • Number of events 3 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 2 • 28 days
|
|
Investigations
Creatinine increased
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Investigations
Anemia
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Investigations
Weight gain
|
0.00%
0/22 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Metabolism and nutrition disorders
Hyperglycemia, intermittent
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 2 • 28 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
1/22 • Number of events 3 • 28 days
|
0.00%
0/24 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
3/22 • Number of events 3 • 28 days
|
16.7%
4/24 • Number of events 6 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
6/22 • Number of events 8 • 28 days
|
29.2%
7/24 • Number of events 7 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.6%
3/22 • Number of events 3 • 28 days
|
8.3%
2/24 • Number of events 3 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.5%
1/22 • Number of events 2 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
1/22 • Number of events 1 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
2/22 • Number of events 3 • 28 days
|
0.00%
0/24 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
4.5%
1/22 • Number of events 2 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • Number of events 3 • 28 days
|
0.00%
0/24 • 28 days
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • Number of events 4 • 28 days
|
16.7%
4/24 • Number of events 4 • 28 days
|
|
Nervous system disorders
Memory loss
|
9.1%
2/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
Nervous system disorders
Nueropathy
|
0.00%
0/22 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
Nervous system disorders
Paresthesia
|
4.5%
1/22 • Number of events 1 • 28 days
|
8.3%
2/24 • Number of events 2 • 28 days
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • Number of events 2 • 28 days
|
4.2%
1/24 • Number of events 2 • 28 days
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Number of events 1 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Renal and urinary disorders
Urinary hesitancy
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Renal and urinary disorders
Bladder incontinence
|
0.00%
0/22 • 28 days
|
8.3%
2/24 • Number of events 3 • 28 days
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.1%
2/22 • Number of events 2 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
9.1%
2/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • Number of events 1 • 28 days
|
12.5%
3/24 • Number of events 3 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
9.1%
2/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
2/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
1/22 • Number of events 2 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.2%
4/22 • Number of events 5 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.5%
1/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
Vascular disorders
Flushing
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Vascular disorders
Hematuria
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Vascular disorders
Hot flashes
|
13.6%
3/22 • Number of events 3 • 28 days
|
20.8%
5/24 • Number of events 5 • 28 days
|
|
Vascular disorders
Hypertension
|
13.6%
3/22 • Number of events 3 • 28 days
|
4.2%
1/24 • Number of events 6 • 28 days
|
|
Vascular disorders
Thromoembolic event
|
4.5%
1/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
General disorders
Other; Tongue Swelling
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
General disorders
Other; Spinal tenderness
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Other; Stiffness
|
4.5%
1/22 • Number of events 2 • 28 days
|
0.00%
0/24 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Other; Muscle cramp
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Other; Shoulder pain
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Skin and subcutaneous tissue disorders
Other; Slight rash
|
9.1%
2/22 • Number of events 4 • 28 days
|
0.00%
0/24 • 28 days
|
|
Skin and subcutaneous tissue disorders
Other; Dermatitis Scrotum
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
Skin and subcutaneous tissue disorders
Other; Slight thickening of the skin
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
General disorders
Infusion related reaction
|
4.5%
1/22 • Number of events 2 • 28 days
|
4.2%
1/24 • Number of events 1 • 28 days
|
|
General disorders
Other; Fatigue
|
4.5%
1/22 • Number of events 1 • 28 days
|
0.00%
0/24 • 28 days
|
|
Skin and subcutaneous tissue disorders
ecchymois bilateral arms from leukapheresis access site
|
0.00%
0/22 • 28 days
|
4.2%
1/24 • Number of events 2 • 28 days
|
Additional Information
Dr.Gautam Jha
Masonic Cancer Center, University of Minnesota
Phone: 612-624-5373
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place