Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
Study Details
Study Description
Brief Summary
RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.
Detailed Description
PRIMARY OBJECTIVES:
- To determine the response rates following treatment with PD 0332991 in the following malignancies: 1) Metastatic breast cancer, 2) Metastatic colorectal cancer, 3) Metastatic melanoma with CDK4 mutation or amplification, or 4) Cisplatin-refractory, unresectable germ cell tumors.
OUTLINE:
Patients receive oral PD 0332991 once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm 1 - Metastatic breast cancer Metastatic breast cancer PD-0332991 Given orally, 125 mg QD on a 21-day |
Drug: PD-0332991
Given orally, 125 mg QD on a 21-day
Other Names:
|
Experimental: Arm 2 - Metastatic colorectal cancer that harbors the Kras or BRAF mutation Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991 Given orally, 125 mg QD on a 21-day |
Drug: PD-0332991
Given orally, 125 mg QD on a 21-day
Other Names:
|
Experimental: Arm 3 - Advanced or metastatic esophageal and/or gastric cancer Advanced or metastatic esophageal and/or gastric cancer PD-0332991 Given orally, 125 mg QD on a 21-day |
Drug: PD-0332991
Given orally, 125 mg QD on a 21-day
Other Names:
|
Experimental: Arm 4 - Cisplatin-refractory, unresectable germ cell tumors Cisplatin-refractory, unresectable germ cell tumors PD-0332991 Given orally, 125 mg QD on a 21-day |
Drug: PD-0332991
Given orally, 125 mg QD on a 21-day
Other Names:
|
Experimental: Arm 5 - CCND1amplification, CDK4/6mutation, CCND2amplification, OR other functional G1/S alterations 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 |
Drug: PD-0332991
Given orally, 125 mg QD on a 21-day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Response Rates [10 years]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Disease Characteristics:
All Subjects: All subjects treated under this protocol will have histologically documented cancer of one of the following types:
- Metastatic breast cancer (7 triple negative, 23 ER+ after the first 15 patients are enrolled on the non-CCND1cohort; in addition 10 HER2+ for combination trastuzumab and PD0332991 therapy) up to 55 total enrollment slots B. Metastatic colorectal cancer that harbors the Kras or BRAF mutation (15-30 enrollment slots) C. Advanced or metastatic esophageal and/or gastric cancer (15-30 enrollment slots) D. Cisplatin-refractory, unresectable germ cell tumors (15-30 enrollment slots) E. 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. (15-30 enrollment slots)
-
Biopsy Requirements: For Subjects with accessible disease amenable to biopsy: A biopsy will be obtained pre-treatment and in during cycle 1 (while patient is receiving drug) for molecular markers of the cell cycle, and its inhibition.
-
Subjects will be > 18 years old
-
The subject has disease that is assessable by tumor marker, physical, or radiologic means.
-
The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
-
The subject has adequate organ function, defined as follows A. Bilirubin ≤ 1.5 x the upper limit of normal (ULN) B. Serum creatinine ≤ 1.5 x UNL or calculated creatinine clearance ≥ 60 mL/min, and C. For subjects without liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN D. For subjects with liver metastases: alanine aminotransferase (ALT) and aspartate aminotransferase ≤ 5 x ULN
-
All tumors must test positive for Rb expression except:
- ER positive metastatic breast tumors (data now shows all to be Rb positive.) B. 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.
-
The subject has adequate marrow function, defined as follows: A. Absolute neutrophil count (ANC) >1500/mm3 B. Platelets >100,000/mm3, and C. Hemoglobin > 9 g/dL
-
The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
-
Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study and for 3 months after the last dose of protocol drug(s).
-
Female subjects of childbearing potential must have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months.
-
However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, or ovarian suppression.
Exclusion Criteria
-
The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of PD 0332991. . Patients with HER2-overexpressing tumors may receive trastuzumab up to the date of starting therapy, and may continue to receive trastuzumab while receiving PD0332991.
-
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
-
The subject has not recovered from clinically-meaningful toxicity due to prior therapy (i.e., back to baseline or Grade ≤ 1), with the exception of neurotoxicity and alopecia.
-
The subject has untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement of disease unless the subject has a teratoma in which case s/he may be eligible if all other eligibility criteria are met
-
The subject has uncontrolled intercurrent illness including, but not limited to:
-
ongoing or active infection
-
diabetes mellitus
-
hypertension
-
symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months
-
The subject has a baseline corrected QT interval (QTc) > 470 ms.
-
The subject is pregnant or breastfeeding.
-
The subject is known to be positive for the human immunodeficiency virus (HIV). Note:
baseline HIV screening is not required
- The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Abramson Cancer Center of The University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
- Principal Investigator: Peter ODwyer, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
More Information
Publications
None provided.- UPCC 03909
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 |
---|---|---|---|---|---|
Arm/Group Description | Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day | Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day | Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day | Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day | 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 |
Period Title: Overall Study | |||||
STARTED | 63 | 18 | 19 | 30 | 11 |
COMPLETED | 63 | 18 | 19 | 30 | 11 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | Total |
---|---|---|---|---|---|---|
Arm/Group Description | Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day | Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day | Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day | Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day | 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 of all reporting groups |
Overall Participants | 63 | 18 | 19 | 30 | 11 | 141 |
Age (Count of Participants) | ||||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
1
3.3%
|
0
0%
|
1
0.7%
|
Between 18 and 65 years |
48
76.2%
|
10
55.6%
|
11
57.9%
|
29
96.7%
|
11
100%
|
109
77.3%
|
>=65 years |
15
23.8%
|
8
44.4%
|
8
42.1%
|
0
0%
|
0
0%
|
31
22%
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
63
100%
|
8
44.4%
|
4
21.1%
|
4
13.3%
|
9
81.8%
|
88
62.4%
|
Male |
0
0%
|
10
55.6%
|
15
78.9%
|
26
86.7%
|
2
18.2%
|
53
37.6%
|
Race/Ethnicity, Customized (Count of Participants) | ||||||
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black |
3
4.8%
|
1
5.6%
|
1
5.3%
|
3
10%
|
0
0%
|
8
5.7%
|
Other |
2
3.2%
|
1
5.6%
|
0
0%
|
4
13.3%
|
0
0%
|
7
5%
|
White |
58
92.1%
|
16
88.9%
|
18
94.7%
|
23
76.7%
|
11
100%
|
126
89.4%
|
Region of Enrollment (participants) [Number] | ||||||
United States |
63
100%
|
18
100%
|
19
100%
|
30
100%
|
11
100%
|
141
100%
|
Outcome Measures
Title | Response Rates |
---|---|
Description | 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) |
Time Frame | 10 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 |
---|---|---|---|---|---|
Arm/Group Description | Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day | Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day | Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day | Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day | 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 |
Measure Participants | 63 | 18 | 19 | 30 | 11 |
partial response |
4
6.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
stable disease |
32
50.8%
|
6
33.3%
|
6
31.6%
|
17
56.7%
|
3
27.3%
|
progressive disease |
25
39.7%
|
8
44.4%
|
4
21.1%
|
9
30%
|
7
63.6%
|
not evaluable for response |
2
3.2%
|
4
22.2%
|
9
47.4%
|
4
13.3%
|
1
9.1%
|
Adverse Events
Time Frame | 10years | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||||
Arm/Group Title | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | |||||
Arm/Group Description | Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day | Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day | Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day | Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day | 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 | |||||
All Cause Mortality |
||||||||||
Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/63 (0%) | 0/18 (0%) | 1/19 (5.3%) | 0/30 (0%) | 1/11 (9.1%) | |||||
Serious Adverse Events |
||||||||||
Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/63 (1.6%) | 10/18 (55.6%) | 11/19 (57.9%) | 10/30 (33.3%) | 4/11 (36.4%) | |||||
Blood and lymphatic system disorders | ||||||||||
anemia | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 5/19 (26.3%) | 5 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
thromboembolic event | 0/63 (0%) | 0 | 2/18 (11.1%) | 2 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Gastrointestinal disorders | ||||||||||
bowel obstruction | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
diarrhea | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
GI bleed | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
mucositis | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
General disorders | ||||||||||
fever | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Investigations | ||||||||||
elevated alk phos | 0/63 (0%) | 0 | 2/18 (11.1%) | 2 | 3/19 (15.8%) | 3 | 0/30 (0%) | 0 | 1/11 (9.1%) | 1 |
elavated ALT | 0/63 (0%) | 0 | 2/18 (11.1%) | 2 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
elevated AST | 0/63 (0%) | 0 | 2/18 (11.1%) | 2 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
leukopenia | 0/63 (0%) | 0 | 5/18 (27.8%) | 5 | 4/19 (21.1%) | 4 | 10/30 (33.3%) | 10 | 0/11 (0%) | 0 |
lymphopenia | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 6/19 (31.6%) | 6 | 0/30 (0%) | 0 | 1/11 (9.1%) | 1 |
neutropenia | 0/63 (0%) | 0 | 6/18 (33.3%) | 6 | 6/19 (31.6%) | 6 | 10/30 (33.3%) | 10 | 2/11 (18.2%) | 2 |
thrombocytopenia | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 2/19 (10.5%) | 2 | 5/30 (16.7%) | 5 | 2/11 (18.2%) | 2 |
Nervous system disorders | ||||||||||
nausea | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
Psychiatric disorders | ||||||||||
confusion | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 40/63 (63.5%) | 18/18 (100%) | 19/19 (100%) | 25/30 (83.3%) | 11/11 (100%) | |||||
Blood and lymphatic system disorders | ||||||||||
anemia | 34/63 (54%) | 34 | 10/18 (55.6%) | 10 | 7/19 (36.8%) | 7 | 7/30 (23.3%) | 7 | 5/11 (45.5%) | 5 |
thromboembolic event | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Ear and labyrinth disorders | ||||||||||
tinnitus | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
Eye disorders | ||||||||||
blurred vision | 2/63 (3.2%) | 2 | 0/18 (0%) | 0 | 2/19 (10.5%) | 2 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
burning eyes | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
dry eyes | 1/63 (1.6%) | 1 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Gastrointestinal disorders | ||||||||||
belching | 2/63 (3.2%) | 2 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
bloating | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
bowel obstruction | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
constipation | 5/63 (7.9%) | 5 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 1/30 (3.3%) | 1 | 1/11 (9.1%) | 1 |
diarrhea | 13/63 (20.6%) | 13 | 2/18 (11.1%) | 2 | 4/19 (21.1%) | 4 | 3/30 (10%) | 3 | 1/11 (9.1%) | 1 |
dry mouth | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
dyspepsia | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
early satiety | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
esophagitis | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
epigastric discomfort | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
flatulence | 4/63 (6.3%) | 4 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
GERD | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
GI bleed | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
heartburn | 5/63 (7.9%) | 5 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
hiccups | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Indigestion | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
mouth sensitivity | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 2/30 (6.7%) | 2 | 0/11 (0%) | 0 |
mucositis | 7/63 (11.1%) | 7 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
vomiting | 0/63 (0%) | 0 | 3/18 (16.7%) | 3 | 4/19 (21.1%) | 4 | 3/30 (10%) | 3 | 2/11 (18.2%) | 2 |
General disorders | ||||||||||
aches | 9/63 (14.3%) | 9 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
arthalgia | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 2/30 (6.7%) | 2 | 1/11 (9.1%) | 1 |
fatigue | 28/63 (44.4%) | 28 | 8/18 (44.4%) | 8 | 9/19 (47.4%) | 9 | 9/30 (30%) | 9 | 2/11 (18.2%) | 2 |
fever | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
liver pain | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
lower extemity edema | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
myalgia | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 1/11 (9.1%) | 1 |
neck pain | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Immune system disorders | ||||||||||
seasonal allergies | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Infections and infestations | ||||||||||
bruising | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
bladder infection | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
flu | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
pneumonia | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
sinus infection | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
urinary tract infection | 2/63 (3.2%) | 2 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 2/11 (18.2%) | 2 |
viral infection | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Investigations | ||||||||||
elevated alk phos | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
elavated ALT | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 2/30 (6.7%) | 2 | 0/11 (0%) | 0 |
elevated AST | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 2/30 (6.7%) | 2 | 0/11 (0%) | 0 |
elevated creatinine | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 2/11 (18.2%) | 2 |
hyperbilirubinemia | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
leukopenia | 17/63 (27%) | 17 | 0/18 (0%) | 0 | 9/19 (47.4%) | 9 | 11/30 (36.7%) | 11 | 2/11 (18.2%) | 2 |
lymphopenia | 10/63 (15.9%) | 10 | 2/18 (11.1%) | 2 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 1/11 (9.1%) | 1 |
neutropenia | 18/63 (28.6%) | 18 | 6/18 (33.3%) | 6 | 7/19 (36.8%) | 7 | 9/30 (30%) | 9 | 1/11 (9.1%) | 1 |
thrombocytopenia | 26/63 (41.3%) | 26 | 10/18 (55.6%) | 10 | 9/19 (47.4%) | 9 | 9/30 (30%) | 9 | 6/11 (54.5%) | 6 |
weight loss | 1/63 (1.6%) | 1 | 5/18 (27.8%) | 5 | 0/19 (0%) | 0 | 2/30 (6.7%) | 2 | 0/11 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||||
anorexia | 7/63 (11.1%) | 7 | 4/18 (22.2%) | 4 | 5/19 (26.3%) | 5 | 3/30 (10%) | 3 | 0/11 (0%) | 0 |
dehydration | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||
joint stiffness | 3/63 (4.8%) | 3 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Nervous system disorders | ||||||||||
dysguesia | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 2/19 (10.5%) | 2 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
headache | 4/63 (6.3%) | 4 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 3/30 (10%) | 3 | 0/11 (0%) | 0 |
lightheadedness | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
nausea | 9/63 (14.3%) | 9 | 7/18 (38.9%) | 7 | 4/19 (21.1%) | 4 | 4/30 (13.3%) | 4 | 2/11 (18.2%) | 2 |
neuropathy | 2/63 (3.2%) | 2 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
nipple sensitivity | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
orthostasis | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
unsteady gait | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
vertigo | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Psychiatric disorders | ||||||||||
confusion | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||
cough | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
epistaxis | 1/63 (1.6%) | 1 | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
hoarseness | 0/63 (0%) | 0 | 1/18 (5.6%) | 1 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
shortness of breath | 2/63 (3.2%) | 2 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
sore throat | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
wheezing | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||
acne | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
alopecia | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 1/30 (3.3%) | 1 | 0/11 (0%) | 0 |
dry skin | 2/63 (3.2%) | 2 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
night sweats | 0/63 (0%) | 0 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
pruritis | 1/63 (1.6%) | 1 | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 2/30 (6.7%) | 2 | 0/11 (0%) | 0 |
rash | 3/63 (4.8%) | 3 | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 3/30 (10%) | 3 | 0/11 (0%) | 0 |
Vascular disorders | ||||||||||
hypotension | 0/63 (0%) | 0 | 2/18 (11.1%) | 2 | 1/19 (5.3%) | 1 | 0/30 (0%) | 0 | 0/11 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Jennifer Louie, Program Manager |
---|---|
Organization | University of Pennsylvania |
Phone | 267-414-6179 |
Jennifer.Louie2@pennmedicine.upenn.edu |
- UPCC 03909