Trial Outcomes & Findings for A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Untreated, Advanced Non-Small Cell Lung Cancer (NCT NCT01268059)
NCT ID: NCT01268059
Last Updated: 2020-12-23
Results Overview
A DLT was defined as: 1. Any treatment-related Grade 3 or higher non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: 1. Grade 3 fever (in the absence of neutropenia) defined as more than (\>) 40.0 degree Celcius (\> 104.0 degree Fahrenheit) that resolved to normal or baseline within 24 hours of treatment and was not considered a serious adverse event (SAE); or 2. Grade 3 rigors/chills that responded to optimal therapy. 2. Any treatment-related Grade 3 or higher hematologic toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
99 participants
Primary outcome timeframe
From Day 1 to Day 21 of first cycle
Results posted on
2020-12-23
Participant Flow
Overall, 99 participants were enrolled in the study, (4 participants, all from North America sites, were enrolled in the Phase 1b part of the study and 95 participants in Phase 2 part of the study). Of 95 participants, 14 were enrolled from Japan sites, and 81 were from North American and European Union (EU) sites.
Participant milestones
| Measure |
Carboplatin/Paclitaxel (C/P): North America/EU Population
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
C/P + MEDI-575 (C/P/M): North America/EU Population
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel (C/P): Japan Population
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) administered as an IV infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
C/P + MEDI-575 (C/P/M): Japan Population
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
45
|
6
|
8
|
|
Overall Study
COMPLETED
|
12
|
10
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
28
|
35
|
3
|
5
|
Reasons for withdrawal
| Measure |
Carboplatin/Paclitaxel (C/P): North America/EU Population
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
C/P + MEDI-575 (C/P/M): North America/EU Population
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel (C/P): Japan Population
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) administered as an IV infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
C/P + MEDI-575 (C/P/M): Japan Population
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
0
|
0
|
|
Overall Study
Death
|
20
|
30
|
3
|
5
|
|
Overall Study
Progression of disease
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Untreated, Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin/Paclitaxel (C/P): North America/EU Population
n=40 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
C/P + MEDI-575 (C/P/M): North America/EU Population
n=45 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel (C/P): Japan Population
n=6 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) administered as an IV infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
C/P + MEDI-575 (C/P/M): Japan Population
n=8 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
less than or equal to (<=) 70 years
|
35 Participants
6.6 • n=5 Participants
|
32 Participants
8.2 • n=7 Participants
|
6 Participants
13.9 • n=5 Participants
|
6 Participants
6.0 • n=4 Participants
|
79 Participants
n=21 Participants
|
|
Age, Customized
greater than (>) 70 years
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 21 of first cyclePopulation: The evaluable population for dose determination included all participants who were in Phase 1b, received at least 1 full cycle of MEDI-575 and completed the safety follow-up through the DLT evaluation period or participants who experienced any DLT.
A DLT was defined as: 1. Any treatment-related Grade 3 or higher non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: 1. Grade 3 fever (in the absence of neutropenia) defined as more than (\>) 40.0 degree Celcius (\> 104.0 degree Fahrenheit) that resolved to normal or baseline within 24 hours of treatment and was not considered a serious adverse event (SAE); or 2. Grade 3 rigors/chills that responded to optimal therapy. 2. Any treatment-related Grade 3 or higher hematologic toxicity.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=4 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT): Phase 1b
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From randomization until the end of study (14 months from last participant enrolled or sponsor stopped the study), assessed at every 6 weeks until disease progression and every 3 months until the end of the study (approximately 3 years)Population: The Intent-to-Treat (ITT) North America/EU population included all North America/EU participants who were randomized into Phase 2 portion of the study. The PFS was analyzed for only those participants who had disease progression.
Progression-free survival defined as the time from randomization (randomization referred to the date of treatment assignment) to disease progression (defined according to Response Evaluation Criteria for Solid Tumors \[RECIST\] version 1.1 guidelines) or death due to any cause, whichever occurs first. Participants without progression or death at the time of analysis were censored at their last date of tumor evaluation. PFS was assessed only in North America/European Union (EU) participants. Progression-free survival was evaluated using Kaplan-Meier method.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=19 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=27 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Progression Free-Survival (PFS)
|
5.5 months
Interval 4.7 to 6.5
|
4.6 months
Interval 3.9 to 5.5
|
—
|
—
|
SECONDARY outcome
Timeframe: From initiation of treatment until the end of study (14 months from last participant enrolled or sponsor stopped the study), assessed at every 6 weeks until disease progression and every 3 months until the end of the study (approximately 3 years)Population: The ITT North America/European Union (EU) population included all North America/EU participants who were randomized into Phase 2 portion of the study. The ITT Japanese population included all Japanese participants who were randomized into the Phase 2 portion of the study.
Best overall response of a participant was defined as the best tumor response \[Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)\] observed during the trial period assessed according to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1 criteria. The participant's best overall response assignment depended on the findings of both target and non-target disease and also on the appearance of new lesions. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30 percent (%) in the sum of diameters of target lesion, SD was defined as steady state of disease, and PD was defined as an increase of at least 20% in the sum of diameters of target lesions.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=40 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=41 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
n=6 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
n=8 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Best Overall Response
Unknown
|
7 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Best Overall Response
Complete response
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response
Partial response
|
12 Participants
|
19 Participants
|
2 Participants
|
1 Participants
|
|
Best Overall Response
Stable disease
|
19 Participants
|
12 Participants
|
3 Participants
|
5 Participants
|
|
Best Overall Response
Progressive disease
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From initiation of treatment until the end of study (14 months from last participant enrolled or sponsor stopped the study), assessed at every 6 weeks until disease progression and every 3 months until the end of the study (approximately 3 years)Population: The ITT North America/EU population included all North America/EU participants who were randomized into Phase 2 portion of the study. The ITT Japanese population included all Japanese participants who were randomized into the Phase 2 portion of the study.
The ORR defined as the percentage of participants with confirmed CR or confirmed PR according to RECIST version 1.1 guidelines. Confirmed responses were those that persist on repeat imaging or assessment greater than or equal to (\>=) 4 weeks after the initial documentation of response. The ORR was evaluated using Kaplan-Meier method.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=40 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=41 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
n=6 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
n=8 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
22.5 percentage of participants
Interval 10.8 to 38.5
|
31.7 percentage of participants
Interval 18.1 to 48.1
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
SECONDARY outcome
Timeframe: From initiation of treatment until the end of study (14 months from last participant enrolled or sponsor stopped the study), assessed at every 6 weeks until disease progression and every 3 months until the end of the study (approximately 3 years)Population: The ITT North America/EU population included all North America/EU participants who were randomized into Phase 2 portion of the study. The ITT Japanese population included all Japanese participants who were randomized into the Phase 2 portion of the study. Participants who achieved OR were analyzed for this outcome measure.
The TTR was measured from initiation of study treatment to the first documentation of objective response (OR). The OR defined as the participants with confirmed CR or confirmed PR according to RECIST version 1.1 guidelines. Confirmed responses were those that persist on repeat imaging or assessment \>=4 weeks after the initial documentation of response. The TTR was evaluated using Kaplan-Meier method.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=9 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=13 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
n=2 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
n=1 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Time to Response (TTR)
|
1.4 months
Interval 1.2 to 2.7
|
1.4 months
Interval 1.3 to 1.6
|
2.2 months
Interval 1.4 to 3.1
|
2.8 months
The 95% confidence interval was not determined as only 1 participant was analyzed.
|
SECONDARY outcome
Timeframe: From initiation of treatment until the end of study (14 months from last participant enrolled or sponsor stopped the study), assessed at every 6 weeks until disease progression and every 3 months until the end of the study (approximately 3 years)Population: The ITT North America/EU population included all North America/EU participants who were randomized into Phase 2 portion of the study. The ITT Japanese population included all Japanese participants who were randomized into the Phase 2 portion of the study. Participants who achieved OR were analyzed for this outcome measure.
The DR defined as the duration from the first documentation of OR to the first documented disease progression. Participants without progression at the time of analysis were censored at their last date of tumor evaluation. The DR was evaluated using Kaplan-Meier method.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=9 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=13 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
n=2 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
n=1 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Duration of Response (DR)
|
3.3 months
Interval 1.3 to 4.6
|
4.2 months
Interval 3.7 to 5.0
|
4.9 months
Interval 3.5 to 6.3
|
2.1 months
The 95% confidence interval was not determined as only 1 participant was analyzed.
|
SECONDARY outcome
Timeframe: From initiation of treatment until the end of study (14 months from last participant enrolled or sponsor stopped the study), assessed at every 6 weeks until disease progression and every 3 months until the end of the study (approximately 3 years)Population: The ITT North America/EU population included all North America/EU participants who were randomized into Phase 2 portion of the study. The ITT Japanese population included all Japanese participants who were randomized into the Phase 2 portion of the study. The TTP was analyzed for only those participants who had disease progression.
The TTP was measured from randomization until the documentation of disease progression. Disease progression defined according to RECIST version 1.1 guidelines. Participants without progression at the time of analysis were censored at their last date of tumor evaluation. The TTP was evaluated using Kaplan-Meier method.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=13 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=23 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
n=5 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
n=6 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Time to Progression (TTP)
|
6.4 months
Interval 4.9 to 10.3
|
4.6 months
Interval 3.9 to 6.4
|
6.5 months
Interval 1.4 to 10.7
|
4.6 months
Interval 1.3 to 15.0
|
SECONDARY outcome
Timeframe: From initiation of treatment until the end of study (14 months from last participant enrolled or sponsor stopped the study), assessed at every 6 weeks until disease progression and every 3 months until the end of the study (approximately 3 years)Population: The ITT North America/EU population and the ITT Japanese population included all participants who were randomized into the Phase 2 portion of the study. The "Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
Overall survival defined as the time from initiation of study treatment until death due to any cause. Participants who were still alive at the time of analysis were censored at their last date of last contact. The OS was evaluated using Kaplan-Meier method.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=20 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=27 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
n=3 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
n=5 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
11.8 months
Interval 8.2 to
Upper 95% CI data not determined as an insufficient number of participants had the event.
|
10.0 months
Interval 6.4 to 11.6
|
NA months
Interval 4.3 to
Median and upper 95% CI data not determined as an insufficient number of participants had the event.
|
11.5 months
Interval 2.3 to
Upper 95% CI data not determined as an insufficient number of participants had the event.
|
SECONDARY outcome
Timeframe: From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)Population: The safety population included all participants who received at least one dose of study drug.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=43 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=53 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AE
|
42 Participants
|
53 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
17 Participants
|
25 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)Population: The safety population included all participants who received at least one dose of study drug.
Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs or SAEs were reported.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=43 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=53 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hypertriglyceridaemia
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hypoalbuminaemia
|
3 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hypokalemia
|
8 Participants
|
12 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hypomagnesaemia
|
10 Participants
|
20 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Blood creatinine increased
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Blood magnesium decreased
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Gamma-glutamyl transferase increased
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Electrolyte imbalance
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hypercholesterolaemia
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hyperglycaemia
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hypocalcaemia
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hypoglycaemia
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hyponatraemia
|
4 Participants
|
8 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Hypophosphataemia
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Anaemia
|
15 Participants
|
25 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Febrile neutropenia
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Idiopathic thrombocytopenic purpura
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Leukopenia
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Lymphadenopathy
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Lymphopenia
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Neutropenia
|
7 Participants
|
13 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Thrombocytopenia
|
3 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Activated partial thromboplastin time prolonged
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Haemoglobin decreased
|
1 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Lymphocyte count decreased
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Neutrophil count decreased
|
5 Participants
|
14 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Platelet count decreased
|
5 Participants
|
9 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
White blood cell count decreased
|
4 Participants
|
10 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Alanine aminotransferase increased
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Aspartate aminotransferase increased
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Blood alkaline phosphatase increased
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Blood bilirubin increased
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Iron deficiency
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Vitamin B12 deficiency
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Urine analysis abnormal
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Specific gravity urine increased
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Haematuria
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Proteinuria
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Abnormalities in Laboratory Investigations Reported as AEs or SAEs
Pyelocaliectasis
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)Population: The safety population included all participants who received at least one dose of study drug.
The 12-lead ECG data were performed and obtained in triplicate that is 3 ECGs obtained within a 5 minute time period. Number of participants with ECG abnormalities were reported and recorded as AEs.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=43 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=53 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as AEs
Atrial fibrillation
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as AEs
Atrial flutter
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as AEs
Atrioventricular block first degree
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as AEs
Myocardial infarction
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as AEs
Tachycardia
|
2 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion and end of infusion), Day 2 (24 hours post Day 1 infusion), Day 8, and Day 15Population: Participants who were treated with MEDI-575 and for whom serum concentrations were available for PK data analyses. Here "Number of Participants Analyzed" denotes the participants evaluable for this outcome measure.
The Cmax of MEDI-575 after first dose is reported.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=4 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=44 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of MEDI-575 After First Dose
|
589.3 microgram per milliliter
Standard Deviation 175.6
|
628.9 microgram per milliliter
Standard Deviation 441.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion and end of infusion), Day 2 (24 hours post Day 1 infusion), Day 8, and Day 15Population: Participants who were treated with MEDI-575 and for whom serum concentrations were available for PK data analyses. Here "Number of Participants Analyzed" denotes the participants evaluable for this outcome measure.
The tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). The Tmax of MEDI-575 after first dose is reported.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=4 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=44 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Time of Maximal Observed Concentration (Tmax) of MEDI-575 After First Dose
|
0.044 day
Standard Deviation 0.002
|
0.046 day
Standard Deviation 0.009
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-infusion and end of infusion), Day 2 (24 hours post Day 1 infusion), Day 8, and Day 15Population: Participants who were treated with MEDI-575 and for whom serum concentrations were available for PK data analyses. Here "Number of Participants Analyzed" denotes the participants evaluable for this outcome measure.
The AUCtau defined as area under the plasma concentration time profile from time zero to the end of the dosing interval (tau). The AUCtau of MEDI-575 after first dose is reported.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=3 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=40 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau) of MEDI-575 After First Dose
|
3550 microgram*day per milliliter
Standard Deviation 496.1
|
4803 microgram*day per milliliter
Standard Deviation 1948
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (pre-infusion and end of infusion on Day 1, Day 2, Day 8, and Day 15); Day 1 of Cycles 2 to 4 (pre-infusion and end of infusion)Population: Participants who were treated with MEDI-575 and for whom serum concentrations were available for PK data analyses. Here "Number of Participants Analyzed" denotes the participants who received at least 4 doses of MEDI-575 and were evaluable for this outcome measure.
The Cmax,ss of MEDI-575 is reported.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=2 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=27 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Maximum Serum Concentration at Steady State (Cmax,ss) of MEDI-575
|
2997 microgram per milliliter
Standard Deviation 2588
|
619.7 microgram per milliliter
Standard Deviation 160.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (pre-infusion and end of infusion on Day 1, Day 2, Day 8, and Day 15); Day 1 of Cycles 2 to 4 (pre-infusion and end of infusion)Population: Participants who were treated with MEDI-575 and for whom serum concentrations were available for PK data analyses. Here "Number of Participants Analyzed" denotes the participants who received at least 4 doses of MEDI-575 and were evaluable for this outcome measure.
The Tmax,ss of MEDI-575 is reported.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=2 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=27 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Time to Maximum Serum Concentration at Steady State (Tmax,ss) of MEDI-575
|
0.042 day
Standard Deviation 0.000
|
0.049 day
Standard Deviation 0.017
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (pre-infusion and end of infusion on Day 1, Day 2, Day 8, and Day 15); Day 1 of Cycles 2 to 4 (pre-infusion and end of infusion)Population: Participants who were treated with MEDI-575 and for whom serum concentrations were available for PK data analyses. Here "Number of Participants Analyzed" denotes the participants who received at least 4 doses of MEDI-575 and were evaluable for this outcome measure.
The Ctrough,ss of MEDI-575 is reported.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=2 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=28 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Trough Serum Concentration at Steady State (Ctrough,ss) of MEDI-575
|
375 microgram per milliliter
Standard Deviation 155
|
168 microgram per milliliter
Standard Deviation 75.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (prior to infusion) of Cycles 1 to 7 (21-day cycle), end of treatment, 30 and 60 days after the last dose (approximately 3 years)Population: The evaluable population included all participants who were treated with MEDI-575 and for whom at least one serum sample for immunogenicity testing was available.
Immunogenicity assessment included determination of anti-drug (MEDI-575) antibodies in serum samples.
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=4 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=49 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Percentage of Participants With Positive Anti-MEDI-575 Antibodies
|
25.0 percentage of participants
496.1
|
26.5 percentage of participants
1948
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening [Days -28 to -1])Population: Evaluable populations for PDGFRα expression included all randomized participants who had formalin-fixed paraffin-embedded samples available at baseline and had positive-staining for tumor cells.
The immunohistochemical expression of PDGFRα in tumor cells in archived formalin-fixed paraffin-embedded tissue samples collected at baseline are reported. The transmembrane receptor tyrosine kinase PDGFRα plays an important role in human carcinogenesis, both as a direct target on tumor cells and also as a mediator of stromal support for cancer cell growth. The data of positive-staining tumor cells are reported in 3 categories: intensity (1+ \[weak expression, staining in \<5 % of tumor cells\]; 2+ \[moderate expression, staining in \>= 5 % of tumor cells\]; and 3+ \[strong expression, staining in \>5 % of the tumor cells\]), localization (membranous, cytoplasmic, or nuclear), and frequency (rare, occasional, or frequent).
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=1 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=5 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
n=3 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Localization: nuclear
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Intensity: 1+
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Intensity: 2+
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Intensity: 3+
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Localization: cytoplasmic
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Localization: membranous
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Frequency: rare
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Frequency: occasional
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Platelet-derived Growth Factor Receptor Alpha (PDGFRα) Expression in Tumor Cells of Archived Tumor Samples
Frequency: frequent
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Screening [Days -28 to -1])Population: Evaluable populations for PDGFRα expression included all randomized participants who had formalin-fixed paraffin-embedded samples available at baseline and had positive-staining for tumor cells.
The immunohistochemical expression of PDGFRα in stromal cells in archived formalin-fixed paraffin-embedded tissue samples collected at baseline are reported. The transmembrane receptor tyrosine kinase PDGFRα plays an important role in human carcinogenesis, both as a direct target on tumor cells and also as a mediator of stromal support for cancer cell growth. The data of positive-staining stromal cells are reported in 3 categories: intensity (1+ \[weak expression, staining in \<5 % of tumor cells\]; 2+ \[moderate expression, staining in \>= 5 % of tumor cells\]; and 3+ \[strong expression, staining in \>5 % of the tumor cells\]), localization (membranous, cytoplasmic, or nuclear), and frequency (rare, occasional, or frequent).
Outcome measures
| Measure |
Carboplatin/Paclitaxel + MEDI-575 - Phase 1b
n=3 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - North America/EU
n=16 Participants
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel - Japan
n=10 Participants
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel + MEDI-575 - Japan
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
|---|---|---|---|---|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Intensity: 1+
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Intensity: 2+
|
1 Participants
|
10 Participants
|
5 Participants
|
—
|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Intensity: 3+
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Localization: cytoplasmic
|
3 Participants
|
15 Participants
|
10 Participants
|
—
|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Localization: membranous
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Localization: nuclear
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Frequency: rare
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Frequency: occasional
|
1 Participants
|
4 Participants
|
3 Participants
|
—
|
|
Number of Participants With PDGFRα Expression in Stromal Cells of Archived Tumor Samples
Frequency: frequent
|
2 Participants
|
9 Participants
|
6 Participants
|
—
|
Adverse Events
Carboplatin/Paclitaxel + MEDI-575 (Total)
Serious events: 25 serious events
Other events: 53 other events
Deaths: 35 deaths
Carboplatin/Paclitaxel (Total)
Serious events: 17 serious events
Other events: 41 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Carboplatin/Paclitaxel + MEDI-575 (Total)
n=53 participants at risk
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel (Total)
n=43 participants at risk
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.5%
4/53 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Cardiac disorders
Tachycardia
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.8%
2/53 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Asthenia
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Fatigue
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Anal abscess
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Clostridium difficile colitis
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Lobar pneumonia
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Pericolic abscess
|
3.8%
2/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Pneumonia
|
5.7%
3/53 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Pyelonephritis
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Sepsis
|
3.8%
2/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
4/53 • Number of events 5 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
3.8%
2/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
3.8%
2/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Convulsion
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Somnolence
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Syncope
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Transient ischaemic attack
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Psychiatric disorders
Confusional state
|
3.8%
2/53 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Psychiatric disorders
Mental status changes
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.8%
2/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/53 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
1/53 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Vascular disorders
Hypotension
|
1.9%
1/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
Other adverse events
| Measure |
Carboplatin/Paclitaxel + MEDI-575 (Total)
n=53 participants at risk
Carboplatin/paclitaxel regimen (carboplatin AUC = 6 mg/mL\*min, and paclitaxel 200 mg/m\^2) followed by MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles. Participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575, MEDI-575 alone was continued until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal.
|
Carboplatin/Paclitaxel (Total)
n=43 participants at risk
Carboplatin/paclitaxel regimen (carboplatin area under the plasma concentration-time curve \[AUC\] of 6 milligram per milliliter into minute \[mg/mL\*min\], and paclitaxel 200 milligram per square meter \[mg/m\^2\]) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) or until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
45.3%
24/53 • Number of events 73 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
32.6%
14/43 • Number of events 28 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.3%
6/53 • Number of events 23 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
4.7%
2/43 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.6%
12/53 • Number of events 37 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
14.0%
6/43 • Number of events 9 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.9%
10/53 • Number of events 46 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Cardiac disorders
Tachycardia
|
3.8%
2/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
18.9%
10/53 • Number of events 12 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
4.7%
2/43 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Constipation
|
24.5%
13/53 • Number of events 16 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
30.2%
13/43 • Number of events 16 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
45.3%
24/53 • Number of events 49 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
18.6%
8/43 • Number of events 11 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
13.2%
7/53 • Number of events 7 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
9.3%
4/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Nausea
|
50.9%
27/53 • Number of events 41 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
51.2%
22/43 • Number of events 30 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
3/53 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 5 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Gastrointestinal disorders
Vomiting
|
26.4%
14/53 • Number of events 18 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
18.6%
8/43 • Number of events 11 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Asthenia
|
18.9%
10/53 • Number of events 15 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Fatigue
|
58.5%
31/53 • Number of events 54 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
53.5%
23/43 • Number of events 35 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Mucosal inflammation
|
7.5%
4/53 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Non-cardiac chest pain
|
3.8%
2/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Oedema peripheral
|
18.9%
10/53 • Number of events 12 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
0.00%
0/43 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Pain
|
7.5%
4/53 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
General disorders
Pyrexia
|
13.2%
7/53 • Number of events 12 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
9.3%
4/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Infections and infestations
Urinary tract infection
|
7.5%
4/53 • Number of events 5 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
20.9%
9/43 • Number of events 11 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Injury, poisoning and procedural complications
Fall
|
15.1%
8/53 • Number of events 8 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Investigations
Alanine aminotransferase increased
|
9.4%
5/53 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
4.7%
2/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Investigations
Aspartate aminotransferase increased
|
7.5%
4/53 • Number of events 9 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Investigations
Haemoglobin decreased
|
9.4%
5/53 • Number of events 5 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Investigations
Neutrophil count decreased
|
26.4%
14/53 • Number of events 29 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
11.6%
5/43 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Investigations
Platelet count decreased
|
17.0%
9/53 • Number of events 22 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
11.6%
5/43 • Number of events 13 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Investigations
Weight decreased
|
26.4%
14/53 • Number of events 17 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Investigations
White blood cell count decreased
|
18.9%
10/53 • Number of events 23 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
9.3%
4/43 • Number of events 5 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.9%
27/53 • Number of events 50 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
25.6%
11/43 • Number of events 22 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
13.2%
7/53 • Number of events 10 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
14.0%
6/43 • Number of events 7 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.2%
7/53 • Number of events 12 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
11.6%
5/43 • Number of events 7 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.2%
7/53 • Number of events 9 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.3%
6/53 • Number of events 9 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.6%
12/53 • Number of events 19 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
18.6%
8/43 • Number of events 9 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
37.7%
20/53 • Number of events 42 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
23.3%
10/43 • Number of events 14 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.1%
8/53 • Number of events 11 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
9.3%
4/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.5%
4/53 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
4.7%
2/43 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
41.5%
22/53 • Number of events 35 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
30.2%
13/43 • Number of events 22 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.8%
11/53 • Number of events 18 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
4.7%
2/43 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.7%
3/53 • Number of events 5 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
9.3%
4/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.8%
2/53 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.1%
17/53 • Number of events 33 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
32.6%
14/43 • Number of events 25 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.1%
8/53 • Number of events 8 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
14.0%
6/43 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Dizziness
|
11.3%
6/53 • Number of events 7 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Dysgeusia
|
22.6%
12/53 • Number of events 12 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Headache
|
13.2%
7/53 • Number of events 9 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
9.3%
4/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Neuropathy peripheral
|
34.0%
18/53 • Number of events 44 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
25.6%
11/43 • Number of events 16 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Paraesthesia
|
9.4%
5/53 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.4%
14/53 • Number of events 24 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
30.2%
13/43 • Number of events 21 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Psychiatric disorders
Anxiety
|
9.4%
5/53 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
4.7%
2/43 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Psychiatric disorders
Confusional state
|
11.3%
6/53 • Number of events 10 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Psychiatric disorders
Insomnia
|
17.0%
9/53 • Number of events 10 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.9%
10/53 • Number of events 10 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
14.0%
6/43 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.8%
11/53 • Number of events 18 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
14.0%
6/43 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.4%
5/53 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
9.4%
5/53 • Number of events 7 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
7.0%
3/43 • Number of events 3 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.7%
3/53 • Number of events 5 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
9.3%
4/43 • Number of events 6 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
54.7%
29/53 • Number of events 38 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
48.8%
21/43 • Number of events 27 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.4%
5/53 • Number of events 5 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
9.3%
4/43 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.7%
3/53 • Number of events 4 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
4.7%
2/43 • Number of events 2 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
|
Vascular disorders
Hypotension
|
13.2%
7/53 • Number of events 7 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
2.3%
1/43 • Number of events 1 • From signing of informed consent form until 90 days post the last dose treatment (approximately 3 years)
|
Additional Information
Mohammed Dar, MD, Vice President & Head, Clinical Development, Oncology
MedImmune, LLC
Phone: +1 301-398-0000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER