Trial Outcomes & Findings for A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors (NCT NCT02129205)
NCT ID: NCT02129205
Last Updated: 2019-03-29
Results Overview
Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade\>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia \>=72 hours or platelets\<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade\>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 1 up to Day 21
Results posted on
2019-03-29
Participant Flow
Participant milestones
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the maximum tolerated dose (MTD). The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
7
|
11
|
6
|
6
|
2
|
0
|
|
Overall Study
COMPLETED
|
1
|
2
|
2
|
2
|
4
|
7
|
2
|
4
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
3
|
4
|
4
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the maximum tolerated dose (MTD). The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
2
|
3
|
3
|
2
|
1
|
0
|
Baseline Characteristics
A Dose Escalation Study of PF-06650808 in Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
69.5 years
STANDARD_DEVIATION 3.5 • n=4 Participants
|
55 years
STANDARD_DEVIATION 24 • n=27 Participants
|
49.5 years
STANDARD_DEVIATION 2.1 • n=483 Participants
|
51.9 years
STANDARD_DEVIATION 14.7 • n=36 Participants
|
59.9 years
STANDARD_DEVIATION 9.8 • n=10 Participants
|
59.3 years
STANDARD_DEVIATION 13.8 • n=115 Participants
|
60.8 years
STANDARD_DEVIATION 4.7 • n=40 Participants
|
42 years
STANDARD_DEVIATION 28.3 • n=8 Participants
|
—
|
57.2 years
STANDARD_DEVIATION 12.5 • n=95 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
11 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
35 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
5 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
2 participants
n=483 Participants
|
6 participants
n=36 Participants
|
8 participants
n=10 Participants
|
5 participants
n=115 Participants
|
4 participants
n=40 Participants
|
2 participants
n=8 Participants
|
—
|
32 participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
1 participants
n=36 Participants
|
1 participants
n=10 Participants
|
1 participants
n=115 Participants
|
1 participants
n=40 Participants
|
0 participants
n=8 Participants
|
—
|
4 participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
2 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=40 Participants
|
0 participants
n=8 Participants
|
—
|
4 participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 21Population: The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication.
Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade\>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia \>=72 hours or platelets\<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade\>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)
Yes
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)
No
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 yearsPopulation: The analysis population included all participants who received at least 1 dose of study medication and had both baseline and at least 1 post-baseline tumor assessments. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=1 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=4 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response (Part 1 and Part 2)
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 84.2
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 60.2
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
0 Percentage of participants
Interval 0.0 to 84.2
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities AE Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities SAE Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities SAE Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities SAE Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities SAE Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities SAE Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related AE Grade 1
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related AE Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related AE Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related AE Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related AE Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related SAE Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related SAE Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related SAE Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related SAE Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
Treatment related SAE Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities AE Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities AE Grade 2
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities AE Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)
All causalities AE Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. The participants who experienced laboratory test abnormalities were determined by investigators.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
White blood cells decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Anemia
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Hemoglobin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Lymphocyte count increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Lymphopenia
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Neutrophils count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)
Patelets count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus, bicarbonate or carbon dioxide, total protein and lactate dehydrogenase. The participants who experienced laboratory test abnormalities were determined by investigators.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Alanine aminotransferase (ALT) increased
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Alkaline phosphatase increased
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Aspartate aminotransferase (AST) increased
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Bilirubin (Total) increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Creatinine increased
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypercalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hyperglycemia
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hyperkalemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypermagnesemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypernatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypoalbuminemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypocalcemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypoglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypokalemia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypomagnesemia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hyponatremia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)
Hypophosphatemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Urinalysis included urine protein. Microscopic analyses were performed if dipstick was abnormal. The participants who experienced laboratory test abnormalities were determined by investigators.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=10 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=1 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from baseline, diastolic \<50 mm Hg; 2), supine and standing pulse rate \<40 or greater than (\>) 120 beats per minute (bpm).
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=9 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Sitting Diastolic BP < 50 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Sitting Pulse Rate < 40 BPM
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Sitting Pulse Rate > 120 BPM
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Sitting Systolic BP < 90 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Supine Systolic BP < 90
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Supine Diastolic BP < 50 mmHg
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Supine Pulse Rate < 40 BPM
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Supine Pulse Rate > 120 BPM
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Systolic BP < 90 mmHg
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Diastolic BP < 50 mmHg
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Pulse Rate < 40 BPM
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Pulse Rate > 120 BPM
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Increase: Sitting Systolic BP >= 30 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Increase: Sitting Diastolic BP >= 20 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Increase: Systolic BP >= 30 mmHg
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Increase: Diastolic BP >= 20 mmHg
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Decrease: Sitting Systolic BP >= 30 mmHg
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Decrease: Sitting Diastolic BP >= 20 mmHg
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Decrease: Systolic BP >= 30 mmHg
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)
Decrease: Diastolic BP >= 20 mmHg
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Maximum observed serum concentration (Cmax) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data. PF-06650808 is comprised of an antibody (PF-06460005) and a cytotoxic agent (PF-06380101).
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Serum PF-06650808 (ADC)_Cycle 1
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 6200 and 4290 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 11000 and 8030 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 18100 and 19400 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 34600 and 34900 ng/mL, respectively.
|
59440 ng/mL
Geometric Coefficient of Variation 33
|
54220 ng/mL
Geometric Coefficient of Variation 29
|
76480 ng/mL
Geometric Coefficient of Variation 27
|
71390 ng/mL
Geometric Coefficient of Variation 38
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 141000 and 92200 ng/mL, respectively
|
—
|
|
Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Serum PF-06460005 (Total Antibody)_Cycle 1
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 5000 and 3690 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 8920 and 7860 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 21600 and 17700 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 30800 and 26800 ng/mL, respectively.
|
48840 ng/mL
Geometric Coefficient of Variation 29
|
54120 ng/mL
Geometric Coefficient of Variation 17
|
93530 ng/mL
Geometric Coefficient of Variation 53
|
65810 ng/mL
Geometric Coefficient of Variation 35
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 99600 and 62400 ng/mL, respectively.
|
—
|
|
Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Serum PF-06380101 (Unconjugated Payload)_Cycle 1
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.735 and 0.627 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1.180 and 0.536 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.530 and 2.900 ng/mL, respectively.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.430 and 6.450 ng/mL, respectively.
|
6.495 ng/mL
Geometric Coefficient of Variation 75
|
5.916 ng/mL
Geometric Coefficient of Variation 81
|
10.680 ng/mL
Geometric Coefficient of Variation 30
|
9.060 ng/mL
Geometric Coefficient of Variation 82
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 26.100 and 14.400 ng/mL, respectively.
|
—
|
|
Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Serum PF-06650808 (ADC)_Cycle 4
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 11400 ng/mL.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 18200 ng/mL.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 36700 and 38100 ng/mL, respectively.
|
46240 ng/mL
Geometric Coefficient of Variation 12
|
43910 ng/mL
Geometric Coefficient of Variation 17
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 36100 and 64900 ng/mL, respectively.
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Serum PF-06460005 (Total Antibody)_Cycle 4
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 9920 ng/mL.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 11900 ng/mL.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 35100 and 51500 ng/mL, respectively.
|
41610 ng/mL
Geometric Coefficient of Variation 34
|
50640 ng/mL
Geometric Coefficient of Variation 23
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 62400 and 108000 ng/mL, respectively.
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)
Serum PF-06380101 (Unconjugated Payload)_Cycle 4
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 1.200 ng/mL.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 2.180 ng/mL.
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.220 and 4.730 ng/mL, respectively.
|
4.518 ng/mL
Geometric Coefficient of Variation 78
|
4.081 ng/mL
Geometric Coefficient of Variation 54
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2.800 and 15.700 ng/mL, respectively.
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Tmax of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Serum PF-06650808 (ADC)_Cycle 1
|
0.967 hr
Interval 0.95 to 0.983
|
0.974 hr
Interval 0.917 to 1.03
|
0.967 hr
Interval 0.967 to 0.967
|
1.01 hr
Interval 0.983 to 1.03
|
0.967 hr
Interval 0.917 to 1.08
|
1.03 hr
Interval 0.933 to 4.05
|
1.06 hr
Interval 0.967 to 4.0
|
1.04 hr
Interval 0.917 to 4.08
|
1.45 hr
Interval 1.15 to 1.75
|
—
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Serum PF-06460005 (Total Antibody)_Cycle 1
|
0.967 hr
Interval 0.95 to 0.983
|
0.974 hr
Interval 0.917 to 1.03
|
0.967 hr
Interval 0.967 to 0.967
|
1.01 hr
Interval 0.983 to 1.03
|
1.08 hr
Interval 0.917 to 4.02
|
1.02 hr
Interval 0.933 to 3.98
|
1.04 hr
Interval 0.967 to 4.0
|
1.04 hr
Interval 0.95 to 4.08
|
1.45 hr
Interval 1.15 to 1.75
|
—
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Serum PF-06380101 (Unconjugated Payload)_Cycle 1
|
25.3 hr
Interval 25.2 to 25.4
|
24.6 hr
Interval 23.4 to 25.8
|
48.5 hr
Interval 24.8 to 72.1
|
24.6 hr
Interval 23.8 to 25.4
|
24.0 hr
Interval 22.1 to 71.6
|
24.3 hr
Interval 23.0 to 72.3
|
57.9 hr
Interval 23.1 to 75.9
|
69.1 hr
Interval 22.4 to 73.0
|
47.7 hr
Interval 23.8 to 71.6
|
—
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Serum PF-06650808 (ADC)_Cycle 4
|
—
|
0.917 hr
Interval 0.917 to 0.917
|
0.917 hr
Interval 0.917 to 0.917
|
1.00 hr
Interval 0.9 to 1.1
|
2.34 hr
Interval 0.933 to 5.0
|
1.03 hr
Interval 0.917 to 1.07
|
—
|
2.47 hr
Interval 0.933 to 4.0
|
—
|
—
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Serum PF-06460005 (Total Antibody)_Cycle 4
|
—
|
0.917 hr
Interval 0.917 to 0.917
|
0.917 hr
Interval 0.917 to 0.917
|
2.55 hr
Interval 1.1 to 4.0
|
1.00 hr
Interval 0.933 to 1.05
|
1.05 hr
Interval 0.917 to 22.1
|
—
|
0.925 hr
Interval 0.917 to 0.933
|
—
|
—
|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)
Serum PF-06380101 (Unconjugated Payload)_Cycle 4
|
—
|
23.4 hr
Interval 23.4 to 23.4
|
24.6 hr
Interval 24.6 to 24.6
|
13.5 hr
Interval 4.0 to 23.0
|
23.5 hr
Interval 21.9 to 25.2
|
46.4 hr
Interval 5.0 to 70.0
|
—
|
23.6 hr
Interval 23.1 to 24.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Tau refers to the dosing interval, and it equals to 504 hours (3 weeks) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=1 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Serum PF-06650808 (ADC)_Cycle 1
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 partipants had reportable parameter values. Individual participant values are 156000 and 105000 ng.hr/mL, respectively.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 394000 and 255000 ng.hr/mL, respectively.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 515000 and 567000 ng.hr/mL, respectively.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1290000 and 1070000 ng.hr/mL, respectively.
|
1786000 ng*hr/mL
Geometric Coefficient of Variation 17
|
2147000 ng*hr/mL
Geometric Coefficient of Variation 33
|
3659000 ng*hr/mL
Geometric Coefficient of Variation 31
|
2956000 ng*hr/mL
Geometric Coefficient of Variation 39
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 4180000 ng.hr/mL.
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Serum PF-06460005 (Total Antibody)_Cycle 4
|
—
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 399000 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 593000 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2130000 and 1720000 ng.hr/mL, respectively.
|
2234000 ng*hr/mL
Geometric Coefficient of Variation 20
|
2901000 ng*hr/mL
Geometric Coefficient of Variation 33
|
—
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants reportable parameter values. Individual participant values are 3160000 and 6060000 ng.hr/mL, respectively.
|
—
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Serum PF-06460005 (Total Antibody)_Cycle 1
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 122000 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 particpants had reportable parameter values. Individual participant values are 371000 and 265000 ng.hr/mL, respectively.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 689000 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1290000 and 1070000 ng.hr/mL, respectively.
|
2385000 ng*hr/mL
Geometric Coefficient of Variation 24
|
3078000 ng*hr/mL
Geometric Coefficient of Variation 36
|
5116000 ng*hr/mL
Geometric Coefficient of Variation 31
|
3571000 ng*hr/mL
Geometric Coefficient of Variation 48
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 4270000 ng.hr/mL.
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Serum PF-06380101 (Unconjugated Payload)_Cycle 1
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 76.300 and 46.600 ng.hr/mL, respectively.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 48.900 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 291.000 and 228.000 ng.hr/mL, respectively.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 300.000 and 576.000 ng.hr/mL, respectively.
|
814.700 ng*hr/mL
Geometric Coefficient of Variation 96
|
671.500 ng*hr/mL
Geometric Coefficient of Variation 103
|
1307.000 ng*hr/mL
Geometric Coefficient of Variation 19
|
1082.000 ng*hr/mL
Geometric Coefficient of Variation 88
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 2060.000 ng.hr/mL.
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Serum PF-06650808 (ADC)_Cycle 4
|
—
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 365000 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 578000 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participants values are 1550000 and 1150000 ng.hr/mL, respectively.
|
1690000 ng*hr/mL
Geometric Coefficient of Variation 18
|
1899000 ng*hr/mL
Geometric Coefficient of Variation 31
|
—
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 1400000 and 2600000 ng.hr/mL, respectively.
|
—
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)
Serum PF-06380101 (Unconjugated Payload)_Cycle 4
|
—
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 113.00 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 186.000 ng.hr/mL.
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 304.000 and 403.000 ng.hr/mL, respectively.
|
507.400 ng*hr/mL
Geometric Coefficient of Variation 90
|
486.600 ng*hr/mL
Geometric Coefficient of Variation 78
|
—
|
NA ng*hr/mL
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 273.000 and 2040.000 ng.hr/mL, respectively.
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL was calculated as dose/AUCinf, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. CL was only for PF-06650808 (ADC) and Cycle 1.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=1 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Clearance (CL) (Part 1 and Part 2)
|
NA L/hr
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 partipants had reportable parameter values. Individual participant values are 0.118 and 0.143 L/hr, respectively.
|
NA L/hr
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0798 and 0.0808 L/hr, respectively.
|
NA L/hr
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.106 and 0.0703 L/hr, respectively.
|
NA L/hr
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0894 and 0.124 L/hr, respectively.
|
0.08368 L/hr
Geometric Coefficient of Variation 25
|
0.07545 L/hr
Geometric Coefficient of Variation 26
|
0.07924 L/hr
Geometric Coefficient of Variation 30
|
0.07517 L/hr
Geometric Coefficient of Variation 38
|
NA L/hr
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 0.0947 L/hr.
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Vss was calculated as dose/(AUCinf × kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Vss was only for PF-06650808 (ADC) and Cycle 1.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=1 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) (Part 1 and Part 2)
|
NA L
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.43 and 3.45 L, respectively.
|
NA L
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 2.71 and 2.87 L, respectively.
|
NA L
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.51 and 2.20 L, respectively.
|
NA L
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values are 3.39 and 3.81 L, respectively.
|
3.428 L
Geometric Coefficient of Variation 26
|
3.232 L
Geometric Coefficient of Variation 28
|
3.800 L
Geometric Coefficient of Variation 30
|
3.481 L
Geometric Coefficient of Variation 36
|
NA L
Geometric Coefficient of Variation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values.Individual participant values is 5.04.
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4Population: The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Terminal elimination half-life was defined as the time measured for the serum concentration to decrease by one half, and calculated as loge(2)/kel.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=5 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=1 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Serum PF-06380101 (Unconjugated Payload)_Cycle 1
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 45.2 and 26.5 hr, respectively.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 40.4 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 50.3 and 39.9 hr, respectively.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 47.5 and 39.4 hr, respectively.
|
53.06 hr
Standard Deviation 6.0260
|
53.11 hr
Standard Deviation 8.5249
|
59.18 hr
Standard Deviation 7.0486
|
53.52 hr
Standard Deviation 3.4434
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 71.8 hr.
|
—
|
|
Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Serum PF-06650808 (ADC)_Cycle 1
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 20.4 and 16.8 hr, respectively.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 23.5 and 24.9 hr, respectively.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 21.4 and 20.7 hr, respectively.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 27.2 and 20.1 hr, respectively.
|
29.52 hr
Standard Deviation 5.2320
|
30.72 hr
Standard Deviation 5.0245
|
35.12 hr
Standard Deviation 4.1282
|
32.72 hr
Standard Deviation 5.1266
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 40.8 hr.
|
—
|
|
Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Serum PF-06460005 (Total Antibody)_Cycle 1
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 19.1 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 28.7 and 28.7 hr, respectively.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 28.4 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 37.0 and 26.7 hr, respectively.
|
33.62 hr
Standard Deviation 3.4487
|
40.93 hr
Standard Deviation 9.5650
|
49.06 hr
Standard Deviation 13.670
|
39.80 hr
Standard Deviation 9.2477
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 61.1 hr.
|
—
|
|
Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Serum PF-06650808 (ADC)_Cycle 4
|
—
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 20.4 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 18.5 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 28.4 and 20.7 hr, respectively.
|
28.50 hr
Standard Deviation 4.9349
|
30.33 hr
Standard Deviation 4.0991
|
—
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 30.8 and 35.8 hr, respectively.
|
—
|
—
|
|
Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Serum PF-06460005 (Total Antibody)_Cycle 4
|
—
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 26.1 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 24.6 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 33.2 and 23.4 hr, respectively
|
38.85 hr
Standard Deviation 3.7108
|
40.80 hr
Standard Deviation 2.5060
|
—
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 41.8 and 59.2 hr, respectively
|
—
|
—
|
|
Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)
Serum PF-06380101 (Unconjugated Payload)_Cycle 4
|
—
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 43.8 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values is 38.8 hr.
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 45.7 and 49.2 hr, respectively.
|
52.40 hr
Standard Deviation 7.9461
|
53.83 hr
Standard Deviation 6.5961
|
—
|
NA hr
Standard Deviation NA
Summary statistics were not presented if fewer than 3 participants had reportable parameter values. Individual participant values are 48.7 and 61.5 hr, respectively.
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The analysis population included all participants who received at least 1 dose of study medication and had at least 1 post-dose ADA measurements. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Assays to assess for anti drug (anti PF-06650808) antibodies (ADA) were performed. Positive ADA: titer\>=1.88.
Outcome measures
| Measure |
PF-06650808 0.2 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.2 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.4 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 0.8 mg/kg (Part 1)
n=2 Participants
PF-06650808 0.8 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 1.6 mg/kg (Part 1)
n=2 Participants
PF-06650808 1.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.0 mg/kg (Part 1)
n=7 Participants
PF-06650808 2.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 1)
n=11 Participants
PF-06650808 2.4 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.0 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.0 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 3.6 mg/kg (Part 1)
n=6 Participants
PF-06650808 3.6 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 4.68 mg/kg (Part 1)
n=2 Participants
PF-06650808 4.68 mg/kg was administered intravenously on Day 1 of each 21-day cycle for 4 months or until disease progression, participant refusal or unacceptable toxicity occurred.
|
PF-06650808 2.4 mg/kg (Part 2)
Part 2 of PF-06650808 was planned to inlcude the participants with Notch3 expressing triple negative breast cancer at the MTD. The MTD of PF-06650808 was determined to be 2.4 mg/kg in Part 1. The Part 2 was not conducted as the termination of study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The study was prematurely terminated prior to the start of dose expansion phase (Part 2).
Progression Free Survival was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of disease progression or to death due to any cause, whichever occurs first. Overall survival was defined as the time from initial dose until death from any cause, and is measured in the intent to treat population.
Outcome measures
Outcome data not reported
Adverse Events
PF-06650808 0.2 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06650808 0.4 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06650808 0.8 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06650808 1.6 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-06650808 2.0 mg/kg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
PF-06650808 2.4 mg/kg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
PF-06650808 3.0 mg/kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06650808 3.6 mg/kg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06650808 4.68 mg/kg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-06650808 0.2 mg/kg
n=2 participants at risk
PF-06650808 0.2 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 0.4 mg/kg
n=2 participants at risk
PF-06650808 0.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 0.8 mg/kg
n=2 participants at risk
PF-06650808 0.8 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 1.6 mg/kg
n=2 participants at risk
PF-06650808 1.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 2.0 mg/kg
n=7 participants at risk
PF-06650808 2.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 2.4 mg/kg
n=11 participants at risk
PF-06650808 2.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 3.0 mg/kg
n=6 participants at risk
PF-06650808 3.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 3.6 mg/kg
n=6 participants at risk
PF-06650808 3.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 4.68 mg/kg
n=2 participants at risk
PF-06650808 4.68 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Asthenia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Disease progression
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Pyrexia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
Other adverse events
| Measure |
PF-06650808 0.2 mg/kg
n=2 participants at risk
PF-06650808 0.2 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 0.4 mg/kg
n=2 participants at risk
PF-06650808 0.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 0.8 mg/kg
n=2 participants at risk
PF-06650808 0.8 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 1.6 mg/kg
n=2 participants at risk
PF-06650808 1.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 2.0 mg/kg
n=7 participants at risk
PF-06650808 2.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 2.4 mg/kg
n=11 participants at risk
PF-06650808 2.4 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 3.0 mg/kg
n=6 participants at risk
PF-06650808 3.0 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 3.6 mg/kg
n=6 participants at risk
PF-06650808 3.6 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
PF-06650808 4.68 mg/kg
n=2 participants at risk
PF-06650808 4.68 mg/kg was administered on Day 1 of each 21 day cycle per the DAI as an IV infusion over approximately 60 minutes.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
27.3%
3/11 • 3 years
|
0.00%
0/6 • 3 years
|
33.3%
2/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
18.2%
2/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
18.2%
2/11 • 3 years
|
33.3%
2/6 • 3 years
|
50.0%
3/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
36.4%
4/11 • 3 years
|
16.7%
1/6 • 3 years
|
50.0%
3/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
27.3%
3/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
18.2%
2/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
57.1%
4/7 • 3 years
|
45.5%
5/11 • 3 years
|
33.3%
2/6 • 3 years
|
16.7%
1/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
71.4%
5/7 • 3 years
|
18.2%
2/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
General disorders
Adverse drug reaction
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Asthenia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Chest discomfort
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Chest pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Chills
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
General disorders
Fatigue
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
50.0%
1/2 • 3 years
|
42.9%
3/7 • 3 years
|
72.7%
8/11 • 3 years
|
50.0%
3/6 • 3 years
|
50.0%
3/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Induration
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Malaise
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
3/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
General disorders
Pyrexia
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
18.2%
2/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
18.2%
2/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
33.3%
2/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
9.1%
1/11 • 3 years
|
33.3%
2/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Blood creatine increased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Blood parathyroid hormone increased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
33.3%
2/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
18.2%
2/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
18.2%
2/11 • 3 years
|
33.3%
2/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
Weight decreased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
18.2%
2/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
White blood cell count
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
36.4%
4/11 • 3 years
|
33.3%
2/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Investigations
White blood cell count increased
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • 3 years
|
100.0%
2/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
57.1%
4/7 • 3 years
|
45.5%
5/11 • 3 years
|
100.0%
6/6 • 3 years
|
50.0%
3/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
36.4%
4/11 • 3 years
|
33.3%
2/6 • 3 years
|
16.7%
1/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
18.2%
2/11 • 3 years
|
33.3%
2/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
42.9%
3/7 • 3 years
|
27.3%
3/11 • 3 years
|
16.7%
1/6 • 3 years
|
33.3%
2/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
18.2%
2/11 • 3 years
|
33.3%
2/6 • 3 years
|
16.7%
1/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
27.3%
3/11 • 3 years
|
16.7%
1/6 • 3 years
|
66.7%
4/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
18.2%
2/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
28.6%
2/7 • 3 years
|
18.2%
2/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
36.4%
4/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
14.3%
1/7 • 3 years
|
18.2%
2/11 • 3 years
|
33.3%
2/6 • 3 years
|
16.7%
1/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
42.9%
3/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Nervous system disorders
Sedation
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
18.2%
2/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/7 • 3 years
|
27.3%
3/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
36.4%
4/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
28.6%
2/7 • 3 years
|
45.5%
5/11 • 3 years
|
66.7%
4/6 • 3 years
|
33.3%
2/6 • 3 years
|
50.0%
1/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
42.9%
3/7 • 3 years
|
36.4%
4/11 • 3 years
|
0.00%
0/6 • 3 years
|
33.3%
2/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
18.2%
2/11 • 3 years
|
16.7%
1/6 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
50.0%
1/2 • 3 years
|
14.3%
1/7 • 3 years
|
9.1%
1/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
100.0%
2/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Vascular disorders
Flushing
|
50.0%
1/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
27.3%
3/11 • 3 years
|
16.7%
1/6 • 3 years
|
33.3%
2/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/7 • 3 years
|
0.00%
0/11 • 3 years
|
16.7%
1/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
0.00%
0/2 • 3 years
|
14.3%
1/7 • 3 years
|
0.00%
0/11 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/6 • 3 years
|
0.00%
0/2 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER