Trial Outcomes & Findings for Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer (NCT NCT00392821)
NCT ID: NCT00392821
Last Updated: 2022-06-06
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = Percentage of Patients Who Experience an Objective Response (CR+ PR) to Treatment. In oncology, this outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
78 participants
Primary outcome timeframe
18 months
Results posted on
2022-06-06
Participant Flow
Participant milestones
| Measure |
Phase 1 Dose Level 1
sorafenib 400 mg BID and everolimus 35 mg once weekly
|
Phase 1 Dose Level -1
Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly
|
Phase II
200 mg PO BID and everolimus 35 mg PO once weekly
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
69
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
69
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer
Baseline characteristics by cohort
| Measure |
Phase 1 Dose Level 1
n=3 Participants
sorafenib 400 mg BID and everolimus 35 mg once weekly
|
Phase 1 Dose Level -1
n=6 Participants
Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly
|
Phase II
n=69 Participants
200 mg PO BID and everolimus 35 mg PO once weekly
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
69 participants
n=5 Participants
|
78 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Pts who received MTD dose also called Phase II dose (Sorafenib 200 mg PO BID, everolimus 35 mg). The 6 phase I pts and 69 phase II pts treated at this dose level are combined to evaluate the efficacy of the MTD/phase II dose. The Ph I and Ph II results are not separated out as the timing of their enrollment (early in Ph 1 or later Ph II) is not relevant to the outcome measure. 3 Ph I patients who were not treated at the MTD are excluded as this Outcome Measure is for MTD/Phase II dose level only
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = Percentage of Patients Who Experience an Objective Response (CR+ PR) to Treatment. In oncology, this outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.
Outcome measures
| Measure |
RAD001 and Sorafenib
n=75 Participants
RAD001 and Sorafenib
Sorafenib: Sorafenib
RAD001: RAD001
|
|---|---|
|
Overall Response Rate (ORR) of Patients Treated at MTD/Phase II Dose Level
|
13 percentage of evaluable patients
Interval 7.0 to 23.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Pts who received MTD dose also called Phase II dose (Sorafenib 200 mg PO BID, everolimus 35 mg). The 6 phase I pts and 69 phase II pts treated at this dose level are combined to evaluate the efficacy of the MTD/phase II dose. The Ph I and Ph II results are not separated out as the timing of their enrollment (early in Ph 1 or later Ph II) is not relevant to the outcome measure. 3 Ph I patients who were not treated at the MTD are excluded as this Outcome Measure is for MTD/Phase II dose level only
Progression is Defined Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% Increase in the Sum of the Longest Diameter of Target Lesions, or a Measurable Increase in a Non-target Lesion, or the Appearance of New Lesions. Progression-free survival was defined as the interval from the date of study entry until the date of tumor progression or death for the patients treated at the MTD/Phase II dose level. This outcome measure is reported for all patients treated at the same dose level and is not separated into Phase I and Phase II. The phase I and phase II results are not separated out as the timing of their enrollment (early in phase 1 or later phase II) is not relevant to the outcome measure.
Outcome measures
| Measure |
RAD001 and Sorafenib
n=75 Participants
RAD001 and Sorafenib
Sorafenib: Sorafenib
RAD001: RAD001
|
|---|---|
|
Progression-Free Survival for Patients Treated at MTD/Phase II Dose Level
|
5.45 Months
Interval 3.9 to 7.6
|
Adverse Events
Phase 1 Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 Dose Level -1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II
Serious events: 21 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1 Dose Level 1
n=3 participants at risk
sorafenib 400 mg BID and everolimus 35 mg once weekly
|
Phase 1 Dose Level -1
n=6 participants at risk
Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly
|
Phase II
n=69 participants at risk
200 mg PO BID and everolimus 35 mg PO once weekly
|
|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Nervous system disorders
CNS Ischemia
|
0.00%
0/3
|
0.00%
0/6
|
5.8%
4/69 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/6
|
2.9%
2/69 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
General disorders
Edema
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
General disorders
Fever
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hernia
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Infections and infestations
Infection - lung (pneumonia)
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/3
|
0.00%
0/6
|
2.9%
2/69 • Number of events 2
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
General disorders
Pain - chest
|
0.00%
0/3
|
0.00%
0/6
|
2.9%
2/69 • Number of events 2
|
|
Gastrointestinal disorders
Pain - stomach
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/6
|
2.9%
2/69 • Number of events 2
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Stabilization of thoracic spine
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Vascular disorders
Vascular - atherosclerosis
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
Other adverse events
| Measure |
Phase 1 Dose Level 1
n=3 participants at risk
sorafenib 400 mg BID and everolimus 35 mg once weekly
|
Phase 1 Dose Level -1
n=6 participants at risk
Sorafenib 200 mg PO BID, everolimus 35 mg PO once weekly
|
Phase II
n=69 participants at risk
200 mg PO BID and everolimus 35 mg PO once weekly
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 2
|
1.4%
1/69 • Number of events 2
|
|
Investigations
Albumin
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
5.8%
4/69 • Number of events 7
|
|
Investigations
Alkaline Phosphatase
|
100.0%
3/3 • Number of events 19
|
16.7%
1/6 • Number of events 1
|
11.6%
8/69 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Number of events 21
|
0.00%
0/6
|
13.0%
9/69 • Number of events 20
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 6
|
16.7%
1/6 • Number of events 1
|
4.3%
3/69 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 7
|
33.3%
2/6 • Number of events 3
|
36.2%
25/69 • Number of events 66
|
|
Investigations
AST, SGOT
|
100.0%
3/3 • Number of events 11
|
16.7%
1/6 • Number of events 2
|
7.2%
5/69 • Number of events 9
|
|
Investigations
Bilirubin - abnormal
|
66.7%
2/3 • Number of events 8
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blisters
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
4.3%
3/69 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiospasm
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
0.00%
0/69
|
|
Nervous system disorders
CNS ischemia
|
0.00%
0/3
|
0.00%
0/6
|
5.8%
4/69 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 15
|
16.7%
1/6 • Number of events 1
|
15.9%
11/69 • Number of events 15
|
|
General disorders
Constitutional symptoms, Other (Temperature intolerance)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/69
|
|
General disorders
Cough
|
100.0%
3/3 • Number of events 16
|
33.3%
2/6 • Number of events 6
|
21.7%
15/69 • Number of events 20
|
|
Investigations
Creatinine increased
|
100.0%
3/3 • Number of events 7
|
33.3%
2/6 • Number of events 4
|
13.0%
9/69 • Number of events 26
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/6
|
10.1%
7/69 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 14
|
50.0%
3/6 • Number of events 4
|
53.6%
37/69 • Number of events 120
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
10.1%
7/69 • Number of events 21
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 2
|
16.7%
1/6 • Number of events 3
|
7.2%
5/69 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • Number of events 3
|
50.0%
3/6 • Number of events 9
|
27.5%
19/69 • Number of events 64
|
|
General disorders
Edema: limb
|
33.3%
1/3 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
14.5%
10/69 • Number of events 20
|
|
General disorders
Edema: NOS
|
66.7%
2/3 • Number of events 7
|
0.00%
0/6
|
2.9%
2/69 • Number of events 2
|
|
General disorders
Edema:headandneck
|
0.00%
0/3
|
0.00%
0/6
|
7.2%
5/69 • Number of events 7
|
|
Investigations
Elevated BUN
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
5.8%
4/69 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Erythema
|
66.7%
2/3 • Number of events 2
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 35
|
83.3%
5/6 • Number of events 8
|
68.1%
47/69 • Number of events 192
|
|
General disorders
fever
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
13.0%
9/69 • Number of events 14
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3
|
0.00%
0/6
|
5.8%
4/69 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Syndrome
|
100.0%
3/3 • Number of events 29
|
33.3%
2/6 • Number of events 3
|
27.5%
19/69 • Number of events 57
|
|
General disorders
Headache
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
21.7%
15/69 • Number of events 53
|
|
Investigations
Hematologic: ANC
|
33.3%
1/3 • Number of events 4
|
0.00%
0/6
|
10.1%
7/69 • Number of events 11
|
|
Investigations
Hematologic: Hemoglobin
|
100.0%
3/3 • Number of events 23
|
83.3%
5/6 • Number of events 7
|
27.5%
19/69 • Number of events 62
|
|
Investigations
Hematologic: Platelets
|
66.7%
2/3 • Number of events 15
|
16.7%
1/6 • Number of events 1
|
33.3%
23/69 • Number of events 64
|
|
Investigations
Hematologic: WBC
|
66.7%
2/3 • Number of events 5
|
0.00%
0/6
|
20.3%
14/69 • Number of events 43
|
|
Investigations
Hematuria
|
66.7%
2/3 • Number of events 3
|
0.00%
0/6
|
5.8%
4/69 • Number of events 10
|
|
General disorders
Hemorrhage(nose)
|
0.00%
0/3
|
0.00%
0/6
|
8.7%
6/69 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
1.4%
1/69 • Number of events 2
|
|
Investigations
Hyperchloridemia
|
66.7%
2/3 • Number of events 4
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Investigations
Hypercholesterolemia
|
66.7%
2/3 • Number of events 12
|
0.00%
0/6
|
13.0%
9/69 • Number of events 28
|
|
Investigations
Hyperglycemia
|
66.7%
2/3 • Number of events 11
|
0.00%
0/6
|
15.9%
11/69 • Number of events 23
|
|
Investigations
Hyperkalemia
|
66.7%
2/3 • Number of events 4
|
0.00%
0/6
|
8.7%
6/69 • Number of events 8
|
|
Investigations
Hyperlipidemia
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
10.1%
7/69 • Number of events 19
|
|
Investigations
Hypermagnesemia
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
|
Investigations
Hypernatremia
|
33.3%
1/3 • Number of events 5
|
0.00%
0/6
|
0.00%
0/69
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/69
|
|
Blood and lymphatic system disorders
Hypertension
|
66.7%
2/3 • Number of events 17
|
0.00%
0/6
|
34.8%
24/69 • Number of events 68
|
|
Investigations
Hypertriglyceridemia
|
33.3%
1/3 • Number of events 4
|
0.00%
0/6
|
8.7%
6/69 • Number of events 16
|
|
Metabolism and nutrition disorders
hyperuricemia
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Investigations
Hypochloridemia
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
0.00%
0/69
|
|
Investigations
Hypokalemia
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
0.00%
0/69
|
|
Investigations
Hypomagnesemia
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
1.4%
1/69 • Number of events 2
|
|
Investigations
Hyponatremia
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
7.2%
5/69 • Number of events 9
|
|
Investigations
Hypophosphatemia
|
66.7%
2/3 • Number of events 7
|
0.00%
0/6
|
10.1%
7/69 • Number of events 13
|
|
Investigations
Increased Alanine transaminase, ALT, SGPT
|
66.7%
2/3 • Number of events 6
|
0.00%
0/6
|
4.3%
3/69 • Number of events 4
|
|
Infections and infestations
Infection (Eye)
|
33.3%
1/3 • Number of events 5
|
0.00%
0/6
|
0.00%
0/69
|
|
Infections and infestations
Infection (joint)
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
0.00%
0/69
|
|
Infections and infestations
Infection(Sinus)
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
5.8%
4/69 • Number of events 5
|
|
Infections and infestations
Infection(Urinary)
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
5.8%
4/69 • Number of events 6
|
|
Psychiatric disorders
insomnia
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 3
|
14.5%
10/69 • Number of events 42
|
|
Investigations
International normalized ratio - abnormal
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
1.4%
1/69 • Number of events 4
|
|
Investigations
Metabolic/Lab, Other (abnormal CO2 )
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/69
|
|
Investigations
Metabolic/Lab, Other (abnormal HCT)
|
100.0%
3/3 • Number of events 13
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Investigations
Metabolic/Lab, Other (abnormal Ketones)
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
0.00%
0/69
|
|
Investigations
Metabolic/Lab, Other (abnormal LDH)
|
100.0%
3/3 • Number of events 10
|
0.00%
0/6
|
0.00%
0/69
|
|
Investigations
Metabolic/Lab, Other(LDH)
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
4.3%
3/69 • Number of events 5
|
|
Nervous system disorders
Mood Alteration (Anxiety)
|
0.00%
0/3
|
0.00%
0/6
|
8.7%
6/69 • Number of events 20
|
|
Nervous system disorders
Mood Alteration (Depression)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
7.2%
5/69 • Number of events 16
|
|
Infections and infestations
Mucositis/stomatitis
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
18.8%
13/69 • Number of events 19
|
|
General disorders
Nausea
|
100.0%
3/3 • Number of events 7
|
50.0%
3/6 • Number of events 7
|
52.2%
36/69 • Number of events 90
|
|
Nervous system disorders
Neuropathy (motor)
|
33.3%
1/3 • Number of events 13
|
0.00%
0/6
|
2.9%
2/69 • Number of events 2
|
|
Nervous system disorders
Neuropathy (NOS)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/69
|
|
Nervous system disorders
neuropathy (sensory)
|
33.3%
1/3 • Number of events 12
|
0.00%
0/6
|
5.8%
4/69 • Number of events 4
|
|
Eye disorders
Ocular, Other (difficulty, L eye)
|
33.3%
1/3 • Number of events 8
|
0.00%
0/6
|
0.00%
0/69
|
|
General disorders
Pain (abdomen)
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
14.5%
10/69 • Number of events 17
|
|
General disorders
Pain (back)
|
0.00%
0/3
|
0.00%
0/6
|
17.4%
12/69 • Number of events 20
|
|
General disorders
Pain (chest)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
11.6%
8/69 • Number of events 8
|
|
General disorders
Pain (flank)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
4.3%
3/69 • Number of events 4
|
|
General disorders
Pain (joint)
|
66.7%
2/3 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
27.5%
19/69 • Number of events 26
|
|
General disorders
Pain (muscle)
|
33.3%
1/3 • Number of events 2
|
0.00%
0/6
|
13.0%
9/69 • Number of events 17
|
|
General disorders
Pain (neck)
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
4.3%
3/69 • Number of events 3
|
|
General disorders
Pain (skin)
|
33.3%
1/3 • Number of events 3
|
0.00%
0/6
|
4.3%
3/69 • Number of events 4
|
|
Investigations
Partial Thromboplastin Time (PTT)
|
33.3%
1/3 • Number of events 5
|
0.00%
0/6
|
0.00%
0/69
|
|
Investigations
Phosphorous
|
33.3%
1/3 • Number of events 4
|
0.00%
0/6
|
1.4%
1/69 • Number of events 1
|
|
Investigations
Proteinuria
|
100.0%
3/3 • Number of events 27
|
50.0%
3/6 • Number of events 10
|
29.0%
20/69 • Number of events 68
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
66.7%
2/3 • Number of events 6
|
50.0%
3/6 • Number of events 5
|
15.9%
11/69 • Number of events 30
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
100.0%
3/3 • Number of events 16
|
33.3%
2/6 • Number of events 7
|
50.7%
35/69 • Number of events 106
|
|
General disorders
Rigors/chills
|
66.7%
2/3 • Number of events 5
|
0.00%
0/6
|
5.8%
4/69 • Number of events 5
|
|
General disorders
Sensory Neuropathy
|
0.00%
0/3
|
0.00%
0/6
|
5.8%
4/69 • Number of events 15
|
|
General disorders
Shingles
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
1.4%
1/69 • Number of events 2
|
|
Infections and infestations
Stomatitis
|
0.00%
0/3
|
0.00%
0/6
|
11.6%
8/69 • Number of events 12
|
|
General disorders
Sweating
|
66.7%
2/3 • Number of events 23
|
0.00%
0/6
|
4.3%
3/69 • Number of events 14
|
|
General disorders
Taste alteration
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
15.9%
11/69 • Number of events 32
|
|
Ear and labyrinth disorders
Tinnitus
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
0.00%
0/69
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/69
|
|
General disorders
Voice changes
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
4.3%
3/69 • Number of events 3
|
|
General disorders
Vomiting
|
66.7%
2/3 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
20.3%
14/69 • Number of events 33
|
|
General disorders
weekness
|
33.3%
1/3 • Number of events 4
|
0.00%
0/6
|
8.7%
6/69 • Number of events 24
|
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