A Phase III Randomized, Open-Label Clinical Trial of BBI-608 Plus Weekly Paclitaxel Versus Weekly Paclitaxel Alone in Patients With Advanced, Previously Treated, Non-Squamous Non-Small Cell Lung Cancer
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Sumitomo Pharma America, Inc.



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CTCAE SOC 
Any Grade 
Grade 1 
Grade 2 
Grade 3 
CTCAE Event Term 
# 
% 
# 
% 
# 
% 
# 
% 
Gastrointestinal Disorders 
 
 
 
 
 
 
 
 
Diarrhea 
289 80.1% 
247 
68.4% 
128 35.5% 
53 
14.7% 
Nausea 
180 49.9% 
135 
37.4% 
77 
21.3% 
8 
2.2% 
Abdominal Pain 
136 37.7% 
97 
26.9% 
76 
21.1% 
16 
4.4% 
Vomiting 
116 32.1% 
82 
22.7% 
42 
11.6% 
11 
3.0% 
Flatulence 
18 
5.0% 
16 
4.4% 
5 
1.4% 
0 
0.0% 
Blood And Lymphatic System Disorders 
 
 
 
 
 
 
 
 
Anemia 
26 
7.2% 
15 
4.2% 
16 
4.4% 
6 
1.7% 
General And Administration Site Conditions 
 
 
 
 
 
 
 
 
Fatigue 
152 42.1% 
92 
25.5% 
102 28.3% 
17 
4.7% 
Investigations 
 
 
 
 
 
 
 
 
Weight Loss 
18 
5.0% 
14 
3.9% 
6 
1.7% 
2 
0.6% 
Metabolism And Nutrition Disorders 
 
 
 
 
 
 
 
 
Anorexia 
117 32.4% 
83 
23.0% 
54 
15.0% 
3 
0.8% 
Dehydration 
41 
11.4% 
12 
3.3% 
26 
7.2% 
8 
2.2% 
Hypokalemia 
22 
6.1% 
15 
4.2% 
4 
1.1% 
4 
1.1% 
Hypomagnesemia 
19 
5.3% 
16 
4.4% 
3 
0.8% 
0 
0.0% 
Renal And Urinary Disorders 
 
 
 
 
 
 
 
 
Urine Discoloration 
46 
12.7% 
45 
12.5% 
1 
0.3% 
0 
0.0% 
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CTCAE SOC 
Any Grade 
Grade 1 
Grade 2 
Grade 3 
CTCAE Event Term 
# 
% 
# 
% 
# 
% 
# 
% 
Gastrointestinal Disorders 
 
 
 
 
 
 
 
 
Diarrhea 
46 
75.4% 
36 
59.0% 
16 
26.2% 
5 
8.2% 
Nausea 
26 
42.6% 
20 
32.8% 
11 
18.0% 
0 
0.0% 
Abdominal Pain 
18 
29.5% 
17 
27.9% 
9 
14.8% 
0 
0.0% 
Vomiting 
13 
21.3% 
10 
16.4% 
4 
6.6% 
2 
3.3% 
Flatulence 
3 
4.9% 
3 
4.9% 
0 
0.0% 
0 
0.0% 
Constitutional 
 
 
 
 
 
 
 
 
Fatigue 
19 
31.1% 
12 
19.7% 
15 
24.6% 
0 
0.0% 
Investigations 
 
 
 
 
 
 
 
 
White Blood Cell Decreased 
4 
6.6% 
4 
6.6% 
0 
0.0% 
0 
0.0% 
Lymphocyte Count Decreased 
3 
4.9% 
3 
4.9% 
2 
3.3% 
0 
0.0% 
Metabolism And Nutrition Disorders 
 
 
 
 
 
 
 
 
Anorexia 
15 
24.6% 
13 
21.3% 
5 
8.2% 
0 
0.0% 
Dehydration 
8 
13.1% 
1 
1.6% 
7 
11.5% 
0 
0.0% 
Hyponatremia 
4 
6.6% 
2 
3.3% 
0 
0.0% 
1 
1.6% 
Renal And Urinary Disorders 
Urine Discoloration 
8 
13.1% 
7 
11.5% 
1 
1.6% 
0 
0.0% 
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System 
CTCAE 
Any Grade 
Grade 1 
Grade 2 
Grade 3 
# 
% 
# 
% 
# 
% 
# 
% 
Gastrointestinal Disorders 
Diarrhea 
20 
74.1% 
15 
55.6% 
9 
33.3% 
3 
11.1% 
 
Nausea 
12 
44.4% 
9 
33.3% 
5 
18.5% 
0 
0.0% 
 
Abdominal Pain 
8 
29.6% 
7 
25.9% 
4 
14.8% 
0 
0.0% 
 
Vomiting 
6 
22.2% 
4 
14.8% 
2 
7.4% 
0 
0.0% 
 
Flatulence 
1 
3.7% 
1 
3.7% 
0 
0.0% 
0 
0.0% 
 
Constipation 
1 
3.7% 
1 
3.7% 
0 
0.0% 
0 
0.0% 
General Disorders And Administration Site  
Fatigue 
6 
22.2% 
1 
3.7% 
5 
18.5% 
1 
3.7% 
Metabolism And Nutrition Disorders 
Anorexia 
4 
14.8% 
4 
14.8% 
1 
3.7% 
0 
0.0% 
 
Dehydration 
4 
14.8% 
1 
3.7% 
3 
11.1% 
0 
0.0% 
 
Hypophosphatemia 
1 
3.7% 
1 
3.7% 
0 
0.0% 
0 
0.0% 
 
Hypokalemia 
1 
3.7% 
1 
3.7% 
0 
0.0% 
0 
0.0% 
 
Hyponatremia 
1 
3.7% 
0 
0.0% 
0 
0.0% 
1 
3.7% 
Blood And Lymphatic System Disorders 
Anemia 
1 
3.7% 
0 
0.0% 
1 
3.7% 
0 
0.0% 
Investigations 
White Blood Cell Decreased 
1 
3.7% 
1 
3.7% 
0 
0.0% 
0 
0.0% 
Musculoskeletal And Connective Tissue  
Back Pain 
1 
3.7% 
1 
3.7% 
0 
0.0% 
0 
0.0% 
Nervous System Disorders 
Dizziness 
1 
3.7% 
1 
3.7% 
0 
0.0% 
0 
0.0% 
Psychiatric Disorders 
Insomnia 
1 
3.7% 
0 
0.0% 
1 
3.7% 
0 
0.0% 
Renal And Urinary Disorders 
Urine Discoloration 
1 
3.7% 
1 
3.7% 
0 
0.0% 
0 
0.0% 
Respiratory, Thoracic And Mediastinal  
Dyspnea 
1 
3.7% 
0 
0.0% 
0 
0.0% 
1 
3.7% 
Vascular Disorders 
Hypotension 
1 
3.7% 
0 
0.0% 
1 
3.7% 
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