Clinical trial NCT02826161
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Neoplasms Neoplasms by Site Lung Neoplasms Thoracic Neoplasms Respiratory Tract Neoplasms Bronchial Neoplasms
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2016-11-01; Completion date: 2017-04-24
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an international, multi-center, prospective, randomized, open-label Phase 3 clinical trial of the cancer stemness inhibitor napabucasin administered with weekly paclitaxel versus weekly paclitaxel alone in patients with advanced non-squamous non-small cell lung cancer who have disease progression following systemic treatment with a platinum-based combination regimen in the metastatic setting, who have received treatment with an immune checkpoint inhibitor if a candidate, additional approved therapies, and for whom weekly paclitaxel is an acceptable treatment option.

Detailed description:

Arms: arm 1: Patients randomized to this arm will receive napabucasin administered orally, twice daily in combination with paclitaxel administered intravenously, once weekly, on 3 of every 4 weeks. arm 2: Patients randomized to this arm will receive weekly paclitaxel alone administered intravenously, once weekly, on 3 of every 4 weeks.
Interventions: intervention 1: Napabucasin intervention 2: Paclitaxel
Intervention descriptions: intervention 1: Napabucasin will be administered in continuous 28-day cycles. The starting dose of napabucasin is 240 mg twice daily (480 mg total daily dose) with approximately 12 hours between each dose. Napabucasin should be taken with fluids either 1 hour prior to a meal or 2 hours after a meal. intervention 2: Paclitaxel will be administered intravenously, once weekly, via one-hour infusion at a starting dose-level of 80 mg/m\^2 body surface area. The weekly paclitaxel infusion will be given during 3 out of every 4 weeks, on days 1, 8, and 15 of each 28-day study cycle.

Protocol documents:
Prot_000.pdf: 


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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% 
0 
0.0% 
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Cycle 1
Cycle 3
Skipping Infusion
Cycle 2, Scenario 2
Cycle 2, Scenario 1
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