Trial Outcomes & Findings for Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer (NCT NCT01037790)
NCT ID: NCT01037790
Last Updated: 2021-03-11
Results Overview
Response rates will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) - Disappearance of all target lesions Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline Progressive Disease (PD) - ≥20% increase in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded since treatment started OR The appearance of 1 or more new lesions Stable Disease (SD) - Neither PR or PD Not Evaluable (NE)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
10 years
Results posted on
2021-03-11
Participant Flow
Participant milestones
| Measure |
Arm 1
Metastatic breast cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 2
Metastatic colorectal cancer that harbors the Kras or BRAF mutation
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 3
Advanced or metastatic esophageal and/or gastric cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 4
Cisplatin-refractory, unresectable germ cell tumors
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 5
Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
PD-0332991: Given orally, 125 mg QD on a 21-day
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
18
|
19
|
30
|
11
|
|
Overall Study
COMPLETED
|
63
|
18
|
19
|
30
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=63 Participants
Metastatic breast cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 2
n=18 Participants
Metastatic colorectal cancer that harbors the Kras or BRAF mutation
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 3
n=19 Participants
Advanced or metastatic esophageal and/or gastric cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 4
n=30 Participants
Cisplatin-refractory, unresectable germ cell tumors
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 5
n=11 Participants
Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Total
n=141 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
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
109 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
88 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
58 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
126 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
18 participants
n=7 Participants
|
19 participants
n=5 Participants
|
30 participants
n=4 Participants
|
11 participants
n=21 Participants
|
141 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 10 yearsResponse rates will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) - Disappearance of all target lesions Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline Progressive Disease (PD) - ≥20% increase in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded since treatment started OR The appearance of 1 or more new lesions Stable Disease (SD) - Neither PR or PD Not Evaluable (NE)
Outcome measures
| Measure |
Arm 1
n=63 Participants
Metastatic breast cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 2
n=18 Participants
Metastatic colorectal cancer that harbors the Kras or BRAF mutation
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 3
n=19 Participants
Advanced or metastatic esophageal and/or gastric cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 4
n=30 Participants
Cisplatin-refractory, unresectable germ cell tumors
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 5
n=11 Participants
Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
PD-0332991: Given orally, 125 mg QD on a 21-day
|
|---|---|---|---|---|---|
|
Response Rates
partial response
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rates
stable disease
|
32 Participants
|
6 Participants
|
6 Participants
|
17 Participants
|
3 Participants
|
|
Response Rates
progressive disease
|
25 Participants
|
8 Participants
|
4 Participants
|
9 Participants
|
7 Participants
|
|
Response Rates
not evaluable for response
|
2 Participants
|
4 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
Adverse Events
Arm 1
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Arm 2
Serious events: 10 serious events
Other events: 18 other events
Deaths: 0 deaths
Arm 3
Serious events: 11 serious events
Other events: 19 other events
Deaths: 1 deaths
Arm 4
Serious events: 10 serious events
Other events: 25 other events
Deaths: 0 deaths
Arm 5
Serious events: 4 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1
n=63 participants at risk
Metastatic breast cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 2
n=18 participants at risk
Metastatic colorectal cancer that harbors the Kras or BRAF mutation
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 3
n=19 participants at risk
Advanced or metastatic esophageal and/or gastric cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 4
n=30 participants at risk
Cisplatin-refractory, unresectable germ cell tumors
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 5
n=11 participants at risk
Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
PD-0332991: Given orally, 125 mg QD on a 21-day
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
anemia
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
26.3%
5/19 • Number of events 5 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
bowel obstruction
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Psychiatric disorders
confusion
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
elevated alk phos
|
0.00%
0/63 • 10years
|
11.1%
2/18 • Number of events 2 • 10years
|
15.8%
3/19 • Number of events 3 • 10years
|
0.00%
0/30 • 10years
|
9.1%
1/11 • Number of events 1 • 10years
|
|
Investigations
elavated ALT
|
0.00%
0/63 • 10years
|
11.1%
2/18 • Number of events 2 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
elevated AST
|
0.00%
0/63 • 10years
|
11.1%
2/18 • Number of events 2 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
General disorders
fever
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
leukopenia
|
0.00%
0/63 • 10years
|
27.8%
5/18 • Number of events 5 • 10years
|
21.1%
4/19 • Number of events 4 • 10years
|
33.3%
10/30 • Number of events 10 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
lymphopenia
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
31.6%
6/19 • Number of events 6 • 10years
|
0.00%
0/30 • 10years
|
9.1%
1/11 • Number of events 1 • 10years
|
|
Gastrointestinal disorders
mucositis
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
Nervous system disorders
nausea
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
neutropenia
|
0.00%
0/63 • 10years
|
33.3%
6/18 • Number of events 6 • 10years
|
31.6%
6/19 • Number of events 6 • 10years
|
33.3%
10/30 • Number of events 10 • 10years
|
18.2%
2/11 • Number of events 2 • 10years
|
|
Investigations
thrombocytopenia
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
10.5%
2/19 • Number of events 2 • 10years
|
16.7%
5/30 • Number of events 5 • 10years
|
18.2%
2/11 • Number of events 2 • 10years
|
|
Blood and lymphatic system disorders
thromboembolic event
|
0.00%
0/63 • 10years
|
11.1%
2/18 • Number of events 2 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
Other adverse events
| Measure |
Arm 1
n=63 participants at risk
Metastatic breast cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 2
n=18 participants at risk
Metastatic colorectal cancer that harbors the Kras or BRAF mutation
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 3
n=19 participants at risk
Advanced or metastatic esophageal and/or gastric cancer
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 4
n=30 participants at risk
Cisplatin-refractory, unresectable germ cell tumors
PD-0332991: Given orally, 125 mg QD on a 21-day
|
Arm 5
n=11 participants at risk
Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
PD-0332991: Given orally, 125 mg QD on a 21-day
|
|---|---|---|---|---|---|
|
General disorders
aches
|
14.3%
9/63 • Number of events 9 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Skin and subcutaneous tissue disorders
acne
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Skin and subcutaneous tissue disorders
alopecia
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
Blood and lymphatic system disorders
anemia
|
54.0%
34/63 • Number of events 34 • 10years
|
55.6%
10/18 • Number of events 10 • 10years
|
36.8%
7/19 • Number of events 7 • 10years
|
23.3%
7/30 • Number of events 7 • 10years
|
45.5%
5/11 • Number of events 5 • 10years
|
|
Metabolism and nutrition disorders
anorexia
|
11.1%
7/63 • Number of events 7 • 10years
|
22.2%
4/18 • Number of events 4 • 10years
|
26.3%
5/19 • Number of events 5 • 10years
|
10.0%
3/30 • Number of events 3 • 10years
|
0.00%
0/11 • 10years
|
|
General disorders
arthalgia
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
6.7%
2/30 • Number of events 2 • 10years
|
9.1%
1/11 • Number of events 1 • 10years
|
|
Gastrointestinal disorders
belching
|
3.2%
2/63 • Number of events 2 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
bloating
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Eye disorders
blurred vision
|
3.2%
2/63 • Number of events 2 • 10years
|
0.00%
0/18 • 10years
|
10.5%
2/19 • Number of events 2 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
bowel obstruction
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Infections and infestations
bruising
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Eye disorders
burning eyes
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Infections and infestations
bladder infection
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Psychiatric disorders
confusion
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
constipation
|
7.9%
5/63 • Number of events 5 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
9.1%
1/11 • Number of events 1 • 10years
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
diarrhea
|
20.6%
13/63 • Number of events 13 • 10years
|
11.1%
2/18 • Number of events 2 • 10years
|
21.1%
4/19 • Number of events 4 • 10years
|
10.0%
3/30 • Number of events 3 • 10years
|
9.1%
1/11 • Number of events 1 • 10years
|
|
Eye disorders
dry eyes
|
1.6%
1/63 • Number of events 1 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Skin and subcutaneous tissue disorders
dry skin
|
3.2%
2/63 • Number of events 2 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Nervous system disorders
dysguesia
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
10.5%
2/19 • Number of events 2 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
early satiety
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
elevated alk phos
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
elavated ALT
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
6.7%
2/30 • Number of events 2 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
elevated AST
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
6.7%
2/30 • Number of events 2 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
elevated creatinine
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
18.2%
2/11 • Number of events 2 • 10years
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
1.6%
1/63 • Number of events 1 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
esophagitis
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
epigastric discomfort
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
General disorders
fatigue
|
44.4%
28/63 • Number of events 28 • 10years
|
44.4%
8/18 • Number of events 8 • 10years
|
47.4%
9/19 • Number of events 9 • 10years
|
30.0%
9/30 • Number of events 9 • 10years
|
18.2%
2/11 • Number of events 2 • 10years
|
|
General disorders
fever
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
flatulence
|
6.3%
4/63 • Number of events 4 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
Infections and infestations
flu
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Nervous system disorders
headache
|
6.3%
4/63 • Number of events 4 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
10.0%
3/30 • Number of events 3 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
heartburn
|
7.9%
5/63 • Number of events 5 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
hiccups
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
hyperbilirubinemia
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Vascular disorders
hypotension
|
0.00%
0/63 • 10years
|
11.1%
2/18 • Number of events 2 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Musculoskeletal and connective tissue disorders
joint stiffness
|
4.8%
3/63 • Number of events 3 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
leukopenia
|
27.0%
17/63 • Number of events 17 • 10years
|
0.00%
0/18 • 10years
|
47.4%
9/19 • Number of events 9 • 10years
|
36.7%
11/30 • Number of events 11 • 10years
|
18.2%
2/11 • Number of events 2 • 10years
|
|
Nervous system disorders
lightheadedness
|
0.00%
0/63 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
General disorders
liver pain
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
General disorders
lower extemity edema
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
lymphopenia
|
15.9%
10/63 • Number of events 10 • 10years
|
11.1%
2/18 • Number of events 2 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
9.1%
1/11 • Number of events 1 • 10years
|
|
Gastrointestinal disorders
mouth sensitivity
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
6.7%
2/30 • Number of events 2 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
mucositis
|
11.1%
7/63 • Number of events 7 • 10years
|
5.6%
1/18 • Number of events 1 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
General disorders
myalgia
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
9.1%
1/11 • Number of events 1 • 10years
|
|
Nervous system disorders
nausea
|
14.3%
9/63 • Number of events 9 • 10years
|
38.9%
7/18 • Number of events 7 • 10years
|
21.1%
4/19 • Number of events 4 • 10years
|
13.3%
4/30 • Number of events 4 • 10years
|
18.2%
2/11 • Number of events 2 • 10years
|
|
General disorders
neck pain
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Nervous system disorders
neuropathy
|
3.2%
2/63 • Number of events 2 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
neutropenia
|
28.6%
18/63 • Number of events 18 • 10years
|
33.3%
6/18 • Number of events 6 • 10years
|
36.8%
7/19 • Number of events 7 • 10years
|
30.0%
9/30 • Number of events 9 • 10years
|
9.1%
1/11 • Number of events 1 • 10years
|
|
Skin and subcutaneous tissue disorders
night sweats
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Nervous system disorders
nipple sensitivity
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
Nervous system disorders
orthostasis
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Infections and infestations
pneumonia
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Skin and subcutaneous tissue disorders
pruritis
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
6.7%
2/30 • Number of events 2 • 10years
|
0.00%
0/11 • 10years
|
|
Skin and subcutaneous tissue disorders
rash
|
4.8%
3/63 • Number of events 3 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
10.0%
3/30 • Number of events 3 • 10years
|
0.00%
0/11 • 10years
|
|
Immune system disorders
seasonal allergies
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
3.2%
2/63 • Number of events 2 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Infections and infestations
sinus infection
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Investigations
thrombocytopenia
|
41.3%
26/63 • Number of events 26 • 10years
|
55.6%
10/18 • Number of events 10 • 10years
|
47.4%
9/19 • Number of events 9 • 10years
|
30.0%
9/30 • Number of events 9 • 10years
|
54.5%
6/11 • Number of events 6 • 10years
|
|
Blood and lymphatic system disorders
thromboembolic event
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Ear and labyrinth disorders
tinnitus
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
3.3%
1/30 • Number of events 1 • 10years
|
0.00%
0/11 • 10years
|
|
Nervous system disorders
unsteady gait
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Infections and infestations
urinary tract infection
|
3.2%
2/63 • Number of events 2 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
18.2%
2/11 • Number of events 2 • 10years
|
|
Nervous system disorders
vertigo
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
5.3%
1/19 • Number of events 1 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Infections and infestations
viral infection
|
1.6%
1/63 • Number of events 1 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/63 • 10years
|
16.7%
3/18 • Number of events 3 • 10years
|
21.1%
4/19 • Number of events 4 • 10years
|
10.0%
3/30 • Number of events 3 • 10years
|
18.2%
2/11 • Number of events 2 • 10years
|
|
Investigations
weight loss
|
1.6%
1/63 • Number of events 1 • 10years
|
27.8%
5/18 • Number of events 5 • 10years
|
0.00%
0/19 • 10years
|
6.7%
2/30 • Number of events 2 • 10years
|
0.00%
0/11 • 10years
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
0.00%
0/63 • 10years
|
0.00%
0/18 • 10years
|
0.00%
0/19 • 10years
|
0.00%
0/30 • 10years
|
0.00%
0/11 • 10years
|
Additional Information
Jennifer Louie, Program Manager
University of Pennsylvania
Phone: 267-414-6179
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place