Trial Outcomes & Findings for Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer (NCT NCT01512745)
NCT ID: NCT01512745
Last Updated: 2016-10-17
Results Overview
Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
267 participants
Primary outcome timeframe
30 months
Results posted on
2016-10-17
Participant Flow
Participant milestones
| Measure |
Apatinib
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
91
|
|
Overall Study
COMPLETED
|
136
|
71
|
|
Overall Study
NOT COMPLETED
|
40
|
20
|
Reasons for withdrawal
| Measure |
Apatinib
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Overall Study
Adverse Event
|
22
|
3
|
|
Overall Study
Death
|
9
|
13
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
Baseline characteristics by cohort
| Measure |
Apatinib
n=176 Participants
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
n=91 Participants
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.01 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
56.08 years
STANDARD_DEVIATION 9.74 • n=7 Participants
|
55.37 years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 monthsProgression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Apatinib
n=176 Participants
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
n=91 Participants
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Progression Free Survival(PFS)
|
2.6 month
Interval 2.0 to 2.9
|
1.8 month
Interval 1.4 to 1.9
|
PRIMARY outcome
Timeframe: 30 monthsOverall Survival of the Participants
Outcome measures
| Measure |
Apatinib
n=176 Participants
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
n=91 Participants
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Overall Survival(OS)
|
6.5 month
Interval 4.8 to 7.6
|
4.7 month
Interval 3.6 to 5.4
|
SECONDARY outcome
Timeframe: 30 monthsDisease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.
Outcome measures
| Measure |
Apatinib
n=176 Participants
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
n=91 Participants
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Disease Control Rate(DCR)
|
42.05 percentage of participants
|
8.79 percentage of participants
|
SECONDARY outcome
Timeframe: 30 monthsObjective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)
Outcome measures
| Measure |
Apatinib
n=176 Participants
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
n=91 Participants
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Objective Response Rate(ORR)
|
2.84 percentage of participants
|
0.00 percentage of participants
|
SECONDARY outcome
Timeframe: 30 monthsOutcome measures
| Measure |
Apatinib
n=176 Participants
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
n=91 Participants
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
98.30 percentage of participants
|
90.11 percentage of participants
|
Adverse Events
Apatinib
Serious events: 6 serious events
Other events: 173 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Apatinib
n=176 participants at risk
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
n=91 participants at risk
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.57%
1/176 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
2.8%
5/176 • Number of events 5
|
5.5%
5/91 • Number of events 5
|
Other adverse events
| Measure |
Apatinib
n=176 participants at risk
apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
Placebo
n=91 participants at risk
placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
|
|---|---|---|
|
Renal and urinary disorders
proteinuria
|
47.7%
84/176 • Number of events 84
|
16.5%
15/91 • Number of events 15
|
|
Vascular disorders
hypertension
|
35.2%
62/176 • Number of events 62
|
5.5%
5/91 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
hand-foot syndrome
|
27.8%
49/176 • Number of events 49
|
2.2%
2/91 • Number of events 2
|
|
Hepatobiliary disorders
elevated transaminase
|
27.8%
49/176 • Number of events 49
|
22.0%
20/91 • Number of events 20
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
24.4%
43/176 • Number of events 43
|
14.3%
13/91 • Number of events 13
|
|
Blood and lymphatic system disorders
bleeding
|
19.9%
35/176 • Number of events 35
|
24.2%
22/91 • Number of events 22
|
|
General disorders
fatigue
|
20.5%
36/176 • Number of events 36
|
14.3%
13/91 • Number of events 13
|
|
Hepatobiliary disorders
ALP increased
|
19.9%
35/176 • Number of events 35
|
15.4%
14/91 • Number of events 14
|
|
Hepatobiliary disorders
elevated GGT
|
16.5%
29/176 • Number of events 29
|
16.5%
15/91 • Number of events 15
|
|
Gastrointestinal disorders
abdominal pain
|
15.9%
28/176 • Number of events 28
|
17.6%
16/91 • Number of events 16
|
|
Metabolism and nutrition disorders
decreased appetite
|
14.8%
26/176 • Number of events 26
|
8.8%
8/91 • Number of events 8
|
|
Metabolism and nutrition disorders
hypoproteinemia
|
13.1%
23/176 • Number of events 23
|
8.8%
8/91 • Number of events 8
|
|
Gastrointestinal disorders
diarrhea
|
11.4%
20/176 • Number of events 20
|
3.3%
3/91 • Number of events 3
|
|
Investigations
elevated LDH
|
10.2%
18/176 • Number of events 18
|
13.2%
12/91 • Number of events 12
|
|
Blood and lymphatic system disorders
leukopenia
|
40.3%
71/176 • Number of events 71
|
8.8%
8/91 • Number of events 8
|
|
Blood and lymphatic system disorders
neutropenia
|
37.5%
66/176 • Number of events 66
|
9.9%
9/91 • Number of events 9
|
|
Blood and lymphatic system disorders
anemia
|
25.0%
44/176 • Number of events 44
|
24.2%
22/91 • Number of events 22
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
25.0%
44/176 • Number of events 44
|
6.6%
6/91 • Number of events 6
|
Additional Information
Co-Director of Clinical Trials
Fudan University Shanghai Cancer Center, Shanghai; PLA Cancer Centre, The 81 Hospital of PLA, Nangjing
Phone: 021-64433755
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER