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Table 2 Treatment-related AEs

From: A phase I study of AST1306, a novel irreversible EGFR and HER2 kinase inhibitor, in patients with advanced solid tumors

AEs

 

Diarrhea

Fatigue

Rash

Vomiting

Proteinuria

ALT increased

Anorexia

Hand-foot syndrome

Grade

 

1-2

3

1-2

3

1-2

3

1-2

3

1-2

3

1-2

3

1-2

3

1-2

3

Dose Cohort

QD

400mg (n = 1)

Couse 1

-

-

-

-

1

0

-

-

-

-

-

-

-

-

-

-

All Course

-

-

-

-

1

0

-

-

-

-

-

-

-

-

-

-

800mg (n = 3)

Couse 1

-

-

-

-

1

0

-

-

-

-

-

-

-

-

-

-

All Courses

-

-

-

-

1

0

2

0

-

-

-

-

-

-

-

-

BID

600mg(n = 3)

Couse 1

1

0

-

-

-

-

-

-

-

-

-

-

-

-

1

0

All Courses

1

0

-

-

1

0

-

-

-

-

-

-

-

-

1

0

800mg (n = 3)

Couse 1

1

0

-

-

1

1

-

-

-

-

-

-

-

-

-

-

All Courses

1

1

-

-

1

0

-

-

-

-

1

0

-

-

-

-

1000mg (n = 6)

Couse 1

1

4

-

-

1

0

1

0

-

-

-

-

-

-

-

-

All Courses

1

5

-

-

1

0

1

0

-

-

-

-

-

-

-

-

1200mg (n = 3)

Couse 1

2

0

-

-

-

-

-

-

-

-

-

-

-

-

-

-

All Courses

2

0

3

0

-

-

-

-

-

-

-

-

-

-

-

-

1500mg (n = 6)

Course 1

4

2

-

-

1

0

-

-

-

-

-

-

-

-

-

-

All Courses

4

3

-

-

1

0

-

-

-

-

-

-

-

-

-

-

TID

600mg (n = 0 + 9)*

Couse 1

4

2

-

-

-

-

1

1

-

-

-

-

-

-

-

-

All Courses

5

2

2

0

-

-

3

0

2

0

-

-

1

0

-

-

800mg(n = 8 + 5)*

Couse 1

5 + 3

3 + 1

-

-

0 + 0

0 + 0

-

-

-

-

-

-

-

-

-

-

All Course

5 + 4

4 + 2

1 + 0

0 + 0

1 + 0

0 + 0

-

-

0 + 3

0 + 0

2 + 0

0 + 1

1 + 1

0 + 0

1 + 0

0 + 0

1000mg (n = 6 + 3 + 12)†

Couse 1

5 + 2 + 0

1 + 1 + 0

1 + 0 + 0

0 + 0 + 0

1 + 1 + 0

0 + 0 + 0

0 + 1 + 0

0 + 0 + 0

-

-

-

-

-

-

3 + 0 + 0

0 + 0 + 0

All Courses

5 + 2 + 8

1 + 1 + 1

2 + 0 + 4

0 + 0 + 0

1 + 1 + 2

1 + 0 + 0

0 + 1 + 2

0 + 0 + 0

2 + 0 + 3

0 + 0 + 0

0 + 1 + 3

0 + 0 + 1

0 + 0 + 6

0 + 0 + 0

3 + 0 + 3

0 + 0 + 0

1200mg (n = 3)

Couse 1

1

2

1

0

-

-

2

0

-

-

-

-

-

-

1

0

All Courses

0

3

2

0

-

-

2

0

-

-

-

-

-

-

1

0

 

Total

Couse 1

28

16

0

0

7

0

5

0

0

0

0

0

0

0

5

0

 

39.4%

22.5%

0%

0%

9.9%

0%

7.0%

0%

0%

0%

0%

0%

0%

0

7.0%

0%

 

All Courses

38

23

14

0

11

1

11

0

10

0

7

2

9

0

9

0

 

53.5%

32.4%

19.7%

0%

15.5%

1.4%

15.5%

0%

14.1%

0%

9.9%

2.8%

12.7%

0%

12.7%

0%

  1. *Dose escalation study + Pharmacokinetics extension study.
  2. †Dose escalation study + Pharmacokinetics extension study + Food effect study.
  3. Abbreviations: AEs. Adverse events.
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Journal of Hematology & Oncology

ISSN: 1756-8722

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