Trial Outcomes & Findings for A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors (NCT NCT01248949)
NCT ID: NCT01248949
Last Updated: 2017-03-29
Results Overview
DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
COMPLETED
PHASE1
162 participants
From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
2017-03-29
Participant Flow
A total of 162 participants were screened, of which 46 did not meet eligibility criteria and were considered as screen failures; the remaining 116 participants entered into the study and treated with MEDI3617.
Participant milestones
| Measure |
MEDI3617 SINGLE AGENT TOTAL
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/ PACLITAXEL TOTAL
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
16
|
38
|
13
|
7
|
|
Overall Study
COMPLETED
|
9
|
3
|
1
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
33
|
13
|
37
|
10
|
4
|
Reasons for withdrawal
| Measure |
MEDI3617 SINGLE AGENT TOTAL
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/ PACLITAXEL TOTAL
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
11
|
3
|
1
|
|
Overall Study
Death
|
22
|
7
|
21
|
6
|
2
|
|
Overall Study
Alternative Therapy
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Alternative Therapy.
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Palliative Radiation To Brain Metastases
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Entered Hospice And Refused Follow Up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Participant Went To Hospice
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Per Sponsor Request o Discontinue Drug
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Pi Decision Due To Declining Status
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Pi Discretion Due To Hospitalisation
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lesion In ThoracicSpine Requires Therapy
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.4 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
57.4 Years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
57.7 Years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
60.4 Years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
56.7 Years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
59.2 Years
STANDARD_DEVIATION 11.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)Population: DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.
DLT was defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=23 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=15 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=22 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=11 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=6 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)Population: DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.
The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=23 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=15 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=22 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=11 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=6 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
NA milligram (mg)
The highest dose level was cleared and the MTD was not reached.
|
NA milligram (mg)
A DLT was reported at the highest dose level, but only 5 out of the 6 participants enrolled were evaluable for DLT. Thus, it is unclear if the MTD was exceeded or reached at the highest dose level tested.
|
NA milligram (mg)
The highest dose level was cleared and the MTD was not reached.
|
NA milligram (mg)
The highest dose level was cleared and the MTD was not reached.
|
NA milligram (mg)
A DLT was reported at the highest dose level, but it is unclear if the MTD was exceeded or reached, as only 3 participants were enrolled (all participants were evaluable for DLT).
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 90 days after the last dose of MEDI3617Population: Safety population included all participants who received treatment with MEDI3617.
An adverse event (AE) was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of 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. Treatment-emergent AEs were events occurring after administration of investigational product.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
42 Participants
|
16 Participants
|
38 Participants
|
13 Participants
|
7 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
18 Participants
|
4 Participants
|
18 Participants
|
7 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 90 days after the last dose of MEDI3617Population: Safety population included all participants who received treatment with MEDI3617.
Laboratory evaluations were performed, including hematology and serum chemistry. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to laboratory abnormalities were recorded and reported.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Blood urea increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Blood alkaline phosphatase increased
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Blood creatinine increased
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Blood lactate dehydrogenase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Blood potassium increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Blood triglycerides increased
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
Hematology: Anemia
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
Hematology: Leukopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
Hematology: Neutropenia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
Hematology: Thombocytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
Hematology: White blood cell count decreased
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Gamma-glutamyltransferase increased
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hyperglycaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hyperkalaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hypertriglyceridaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hyperuricaemia
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hypoalbuminaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hypocalcaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hypoglycaemia
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hypokalaemia
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hypomagnesaemia
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)
SerChem: Hyponatremia
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 90 days after the last dose of MEDI3617Population: Safety population included all participants who received treatment with MEDI3617.
Vital signs included parameters such as heart rate, blood pressure, temperature, weight and respiratory rate. An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to vital signs abnormalities were recorded and reported.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Arrhythmia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Sinus tachycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Tachycardia
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Pyrexia
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Weight decreased
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Weight increased
|
9 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Hypertension
|
10 Participants
|
7 Participants
|
13 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)
Hypotension
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 90 days after the last dose of MEDI3617Population: Safety population included all participants who received treatment with MEDI3617.
An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to echocardiogram abnormalities were recorded and reported. The only AE reported was ejection fraction decreased in the MEDI3617 + Paclitaxel total group.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 90 days after the last dose of MEDI3617Population: Safety population included all participants who received treatment with MEDI3617
An AE was any untoward medical occurrence in a participant administered investigational product and which does not necessarily have a causal relationship with this treatment. AEs related to electrocardiogram abnormalities were recorded and reported. The only AE reported was electrocardiogram QT prolonged in the MEDI3617 + Bevacizumab Q2W total group.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration up to 30 days after the last dose of MEDI3617Population: Safety population included all participants who received treatment with MEDI3617
KPS scale: 100 is no evidence of disease; 90 is able to carry on normal activity, minor symptoms of disease; 80 is normal activity with effort, some symptoms of disease; 70 is cares for self; unable to do active work; 60 is requires occasional assistance, but is able to care for most of his needs; 50 is requires considerable assistance with frequent medical care; 40 is disabled, requires special care; 30 is severely disabled, hospitalization is indicated although death is not imminent; 20 is very sick, hospitalization necessary, active support treatment necessary; 10 is moribund, fatal processes progressing rapidly, 0 is dead.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline
|
11 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dosePopulation: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
Cmax is the maximum observed serum concentration of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=41 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=35 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort -2 (n=3)
|
1.39 microgram per milliliter (mcg/ml)
Standard Deviation 0.254
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort -1 (n=2)
|
2.44 microgram per milliliter (mcg/ml)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort 1 (n=6)
|
6.63 microgram per milliliter (mcg/ml)
Standard Deviation 3.48
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort 2 (n=3)
|
50.2 microgram per milliliter (mcg/ml)
Standard Deviation 28.8
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort 3 (n=3)
|
82.4 microgram per milliliter (mcg/ml)
Standard Deviation 2.68
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort 4 (n=3)
|
239 microgram per milliliter (mcg/ml)
Standard Deviation 79.5
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort 5 (n=4)
|
785 microgram per milliliter (mcg/ml)
Standard Deviation 189
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort ovarian cancer expansion (OCE) -1 (n=15)
|
336 microgram per milliliter (mcg/ml)
Standard Deviation 62.2
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort OCE 1 (n=2)
|
346 microgram per milliliter (mcg/ml)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MB 1A (n=4)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
30.4 microgram per milliliter (mcg/ml)
Standard Deviation 26.8
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MB 2A (n=3)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
55.3 microgram per milliliter (mcg/ml)
Standard Deviation 12.6
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MB 3A (n=3)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
235 microgram per milliliter (mcg/ml)
Standard Deviation 90.5
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MB 4A (n=6)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
348 microgram per milliliter (mcg/ml)
Standard Deviation 54.6
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MB 1B (n=7)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
44.5 microgram per milliliter (mcg/ml)
Standard Deviation 39.3
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MB 2B (n=3)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
47.5 microgram per milliliter (mcg/ml)
Standard Deviation 23.3
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MB 3B (n=8)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
116 microgram per milliliter (mcg/ml)
Standard Deviation 35.1
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MB 4B (n=8)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
275 microgram per milliliter (mcg/ml)
Standard Deviation 86.2
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort TT2A (n=9)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
320 microgram per milliliter (mcg/ml)
Standard Deviation 170
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MP1 (n=7)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
114 microgram per milliliter (mcg/ml)
Standard Deviation 22.5
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MP2 (n=6)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
209 microgram per milliliter (mcg/ml)
Standard Deviation 57.4
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MCP1 (n=4)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
200 microgram per milliliter (mcg/ml)
Standard Deviation 25.8
|
|
Maximum Observed Serum Concentration (Cmax) of MEDI3617
Cohort MCP2 (n=3)
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA microgram per milliliter (mcg/ml)
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
585 microgram per milliliter (mcg/ml)
Standard Deviation 491
|
SECONDARY outcome
Timeframe: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dosePopulation: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
AUC0-last is the Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=41 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=35 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort OCE -1 (n=15)
|
2610 day*mcg/mL
Standard Deviation 891
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort -2 (n=3)
|
1.3 day*mcg/mL
Standard Deviation 0.429
|
NA day*mcg/mL
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort -1 (n=2)
|
2.2 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort 1 (n=6)
|
11.9 day*mcg/mL
Standard Deviation 11.8
|
NA day*mcg/mL
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA day*mcg/mL
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA day*mcg/mL
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA day*mcg/mL
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort 2 (n=3)
|
171 day*mcg/mL
Standard Deviation 69
|
NA day*mcg/mL
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort 3 (n=3)
|
438 day*mcg/mL
Standard Deviation 204
|
NA day*mcg/mL
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort 4 (n=3)
|
2610 day*mcg/mL
Standard Deviation 1570
|
NA day*mcg/mL
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort 5 (n=4)
|
3650 day*mcg/mL
Standard Deviation 2600
|
NA day*mcg/mL
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort OCE 1 (n=2)
|
2160 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MB 1A (n=4)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
101 day*mcg/mL
Standard Deviation 48.8
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MB 2A (n=3)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
473 day*mcg/mL
Standard Deviation 223
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MB 3A (n=3)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
2280 day*mcg/mL
Standard Deviation 529
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MB 4A (n=6)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
2710 day*mcg/mL
Standard Deviation 1070
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MB 1B (n=7)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
94.7 day*mcg/mL
Standard Deviation 48.7
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MB 2B (n=3)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
216 day*mcg/mL
Standard Deviation 61.8
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MB 3B (n=8)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
805 day*mcg/mL
Standard Deviation 292
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MB 4B (n=8)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
2310 day*mcg/mL
Standard Deviation 941
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort TT2A (n=9)
|
NA day*mcg/mL
Standard Deviation NA
Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
2590 day*mcg/mL
Standard Deviation 1920
|
NA day*mcg/mL
Standard Deviation NA
Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort TT2A (participants with bevacizumab-refractory glioma), was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MP1 (n=7)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
551 day*mcg/mL
Standard Deviation 331
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MP2 (n=6)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
1460 day*mcg/mL
Standard Deviation 484
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MCP1 (n=4)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
1240 day*mcg/mL
Standard Deviation 882
|
|
Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617
Cohort MCP2 (n=3)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
2890 day*mcg/mL
Standard Deviation 257
|
SECONDARY outcome
Timeframe: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dosePopulation: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
The AUC0-inf is the Area Under the Concentration-Time Curve From Time Zero to infinity of MEDI3617. Here, "n" is number of participants analyzed for this endpoint at a specific dose.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=25 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=8 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=13 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=4 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=3 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MCP1 (n=1)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
2240 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MP1 (n=3)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
849 day*mcg/mL
Standard Deviation 163
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MP2 (n=1)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
2810 day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort OCE -1 (n=12)
|
3280 day*mcg/mL
Standard Deviation 1410
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort OCE 1 (n=2)
|
2490 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MB 1A (n=3)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
110 day*mcg/mL
Standard Deviation 58.1
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MB 2A (n=3)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
628 day*mcg/mL
Standard Deviation 376
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MB 4A (n=2)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
3920 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MB 1B (n=7)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
104 day*mcg/mL
Standard Deviation 61
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MB 2B (n=3)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
252 day*mcg/mL
Standard Deviation 83.2
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MB 3B (n=2)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
1200 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MB 4B (n=1)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
4630 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort -2 (n=1)
|
1.79 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort 1 (n=1)
|
8.12 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA day*mcg/mL
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA day*mcg/mL
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
NA day*mcg/mL
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort 2 (n=2)
|
269 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort 3 (n=3)
|
529 day*mcg/mL
Standard Deviation 269
|
NA day*mcg/mL
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort 4 (n=2)
|
2150 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort 5 (n=2)
|
4230 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day*mcg/mL
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617
Cohort MCP2 (n=2)
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day*mcg/mL
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
3560 day*mcg/mL
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
SECONDARY outcome
Timeframe: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dosePopulation: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
Systemic clearance describes the removal of drug from a volume of serum in a given unit of time (drug loss from the body). It is measured as milliliter per day (mL/day). Here, "n" is number of participants analyzed for this endpoint at a specific dose.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=25 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=8 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=13 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=4 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=3 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Systemic Clearance (CL) of MEDI3617
Cohort OCE -1 (n=12)
|
352 milliliter per day (mL/day)
Standard Deviation 136
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MB 1A (n=3)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
1060 milliliter per day (mL/day)
Standard Deviation 426
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MB 1B (n=7)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
797 milliliter per day (mL/day)
Standard Deviation 499
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort -2 (n=1)
|
2790 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort 1 (n=1)
|
2460 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort 2 (n=2)
|
423 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort 3 (n=3)
|
679 milliliter per day (mL/day)
Standard Deviation 345
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort 4 (n=2)
|
465 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort 5 (n=2)
|
355 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort OCE 1 (n=2)
|
603 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MB 2A (n=3)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
614 milliliter per day (mL/day)
Standard Deviation 363
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MB 4A (n=2)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
388 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MB 2B (n=3)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
847 milliliter per day (mL/day)
Standard Deviation 237
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MB 3B(n=2)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
501 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MB 4B (n=1)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
216 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MP1 (n=3)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
727 milliliter per day (mL/day)
Standard Deviation 157
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MP2 (n=1)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
356 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MCP1 (n=1)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
446 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
|
Systemic Clearance (CL) of MEDI3617
Cohort MCP2 (n=2)
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA milliliter per day (mL/day)
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
424 milliliter per day (mL/day)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
SECONDARY outcome
Timeframe: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dosePopulation: All participants who received treatment with MEDI3617 and for whom PK blood samples were collected and evaluated.
The t1/2 is the time in days required for the concentration of the drug to reach half of its original value. Here, "n" is number of participants analyzed for this endpoint at a specific dose.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=25 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=8 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=13 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=4 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=3 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MB 4B (n=1)
|
NA day
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
10.2 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort -2 (n=1)
|
0.585 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort 1 (n=1)
|
1.26 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort 2 (n=2)
|
5.86 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort 3 (n=3)
|
5.98 day
Standard Deviation 3.09
|
NA day
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort 4 (n=2)
|
7.68 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort 5 (n=2)
|
7.79 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort OCE -1 (n=12)
|
10.4 day
Standard Deviation 3.15
|
NA day
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort OCE 1 (n=2)
|
9.03 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
NA day
Standard Deviation NA
Cohort OCE 1 was part of the MEDI3617 Single agent total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MB 1A (n=3)
|
NA day
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
3.59 day
Standard Deviation 0.983
|
NA day
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MB 2A (n=3)
|
NA day
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
9.67 day
Standard Deviation 3.35
|
NA day
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MB 4A (n=2)
|
NA day
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
12.3 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA day
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MB 1B (n=7)
|
NA day
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
3.9 day
Standard Deviation 2.69
|
NA day
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MB 2B (n=3)
|
NA day
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
5.12 day
Standard Deviation 0.541
|
NA day
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MB 3B(n=2)
|
NA day
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
8.23 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA day
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MP1 (n=3)
|
NA day
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
6.96 day
Standard Deviation 1.59
|
NA day
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MP2 (n=1)
|
NA day
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
9.34 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA day
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MCP1 (n=1)
|
NA day
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
15.1 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
|
Terminal Elimination Half Life (t1/2) of MEDI3617
Cohort MCP2 (n=2)
|
NA day
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA day
Standard Deviation NA
Cohort MCP2 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
11.1 day
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
SECONDARY outcome
Timeframe: Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617Population: All participants who received treatment with MEDI3617.
The immunogenic potential of MEDI3617 was assessed by summarizing the number and percentage of participants who develop detectable ADA. Immunogenicity assessment included determination of anti-drug (MEDI3617) antibodies in serum samples. Samples were measured for the presence of ADA using validated immunoassays.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Time from the first dose of investigational product until end of studyPopulation: Safety population included all participants who received treatment with MEDI3617.
Objective response rate defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time from the first dose of investigational product until end of studyPopulation: Safety population included all participants who received treatment with MEDI3617.
Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated using the Kaplan-Meier method.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Time to Response (TTR)
|
2.6 months
Interval 2.6 to 2.6
|
1.2 months
Interval 1.2 to 1.2
|
2.0 months
Interval 1.6 to 2.3
|
1.7 months
Interval 1.6 to 1.7
|
NA months
No objective response was observed in the MEDI3617 + carboplatin/paclitaxel cohorts.
|
SECONDARY outcome
Timeframe: Time from the first dose of investigational product until end of studyPopulation: Safety population included all participants who received treatment with MEDI3617.
Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
3.7 months
Interval 3.7 to 3.7
|
NA months
Interval 17.8 to 17.8
Due to the lack of available data caused by censoring subjects in the MEDI3617 + bevacizumab Q3W escalation cohorts for this endpoint, median duration of response was not calculable.
|
NA months
Interval 2.9 to 3.7
Due to the lack of available data caused by censoring subjects in the MEDI3617 + bevacizumab Q2W cohorts for this endpoint, median duration of response was not calculable.
|
NA months
Interval 1.6 to 17.7
Due to the lack of available data caused by censoring subjects in the MEDI3617 + paclitaxel cohorts for this endpoint, median duration of response was not calculable.
|
NA months
No objective response was observed in the MEDI3617 + carboplatin/paclitaxel cohorts.
|
SECONDARY outcome
Timeframe: Time from the first dose of investigational product until end of studyPopulation: Safety population included all participants who received treatment with MEDI3617.
Time to progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP was evaluated using the Kaplan-Meier method.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Time to Progression (TTP)
|
1.4 months
Interval 0.0 to 8.6
|
11.4 months
Interval 0.0 to 39.4
|
1.8 months
Interval 0.0 to 5.3
|
3.5 months
Interval 0.0 to 19.4
|
NA months
Interval 0.0 to 4.0
Due to the lack of available data caused by censoring subjects in the MEDI3617 + carboplatin/paclitaxel cohorts for this endpoint, median time to progression was not calculable.
|
SECONDARY outcome
Timeframe: Time from the first dose of investigational product until end of studyPopulation: Safety population included all participants who received treatment with MEDI3617.
PFS was measured from the start of treatment with MEDI3617 until the documentation of disease progression or death due to any cause, whichever occurred first. PFS was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression and were still alive prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had PFS censored on the first date of treatment with MEDI3617. PFS was evaluated using the Kaplan-Meier method.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
1.4 months
Interval 0.0 to 8.6
|
11.4 months
Interval 0.0 to 39.4
|
1.7 months
Interval 0.0 to 5.3
|
3.5 months
Interval 0.0 to 19.4
|
NA months
Interval 0.0 to 4.0
Due to the lack of available data caused by censoring subjects in the MEDI3617 + carboplatin/paclitaxel cohorts for this endpoint, median progression-free survival was not calculable.
|
SECONDARY outcome
Timeframe: Time from the first dose of investigational product until death due to any causePopulation: Safety population included all participants who received treatment with MEDI3617.
Overall survival is defined as the time from the start of treatment with MEDI3617 until death. For the participants who were alive at the end of study or lost to follow-up, overall survival was censored on the last date when participants were known to be alive. Overall survival was evaluated using the Kaplan-Meier method.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=42 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=13 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
11.4 months
Interval 0.3 to 46.8
|
25.7 months
Interval 1.3 to 42.8
|
7.4 months
Interval 0.5 to 33.4
|
14.2 months
Interval 1.0 to 35.7
|
NA months
Interval 1.9 to 34.4
Due to the lack of available data caused by censoring subjects in the MEDI3617 + carboplatin/paclitaxel cohorts for this endpoint, median overall survival was not calculable.
|
SECONDARY outcome
Timeframe: Prior to infusion on Cycle 4 and Cycle 5Population: All participants who received treatment with MEDI3617 and for whom PD blood samples were collected and evaluated.
Profile of Ang2 post MEDI3617 administration in relation to time course of antibody concentrations.
Outcome measures
| Measure |
MEDI3617 SINGLE AGENT TOTAL
n=14 Participants
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=11 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=7 Participants
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + PACLITAXEL TOTAL
n=3 Participants
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=2 Participants
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort -2 (n=2)
|
4.07 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort -2 (n=2)
|
4.28 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -2 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort -1 (n=2)
|
5.11 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort -1 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort 1 (n=3)
|
5.69 nanogram per millileter (ng/mL)
Standard Deviation 4.02
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort 1 (n=2)
|
8.22 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 1 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort 2 (n=1)
|
307.53 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort 2 (n=1)
|
924.66 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 2 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort 3 (n=1)
|
341.21 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort 3 (n=1)
|
265.86 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 3 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort 4 (n=1)
|
288.10 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 4 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort 5 (n=1)
|
1181.14 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort 5 (n=1)
|
1451.43 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort 5 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort OCE -1 (n=3)
|
312.27 nanogram per millileter (ng/mL)
Standard Deviation 151.19
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort OCE -1 (n=3)
|
206.43 nanogram per millileter (ng/mL)
Standard Deviation 83.74
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort OCE -1 was part of the MEDI3617 Single agent total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MB 1A (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
386.13 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MB 1A (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
421.74 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MB 2A (n=3)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
215.71 nanogram per millileter (ng/mL)
Standard Deviation 143.16
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MB 2A (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
228.92 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MB 3A (n=1)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
218.48 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MB 3A (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
247.51 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MB 4A (n=4)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
368.08 nanogram per millileter (ng/mL)
Standard Deviation 257.59
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MB 4A (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
353.73 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4A was part of the MEDI3617 + Bevacizumab Q3W escalation group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MB 1B (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
466.27 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MB 1B (n=1)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
750.61 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 1B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MB 2B (n=1)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
421.03 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MB 2B (n=1)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
387.45 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 2B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4:Cohort MB 3B (n=1)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
141.93 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 3B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MB 4B (n=3)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
229.19 nanogram per millileter (ng/mL)
Standard Deviation 109.02
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MB 4B (n=1)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
174.65 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MB 4B was part of the MEDI3617 + Bevacizumab Q2W Total group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MP1 (n=1)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
339.35 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP1 was part of the MEDI3617 + Paclitaxel group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MP2 (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
210.43 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MP2 (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
166.73 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MP2 was part of the MEDI3617 + Paclitaxel group.
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 4: Cohort MCP1 (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
348.53 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
|
Circulating Levels of Angiopoietin 2 (Ang2)
Cycle 5: Cohort MCP1 (n=2)
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
NA nanogram per millileter (ng/mL)
Standard Deviation NA
Cohort MCP1 was part of the MEDI3617 + Carboplatin/Paclitaxel group.
|
336.31 nanogram per millileter (ng/mL)
Standard Deviation NA
Standard deviation was not calculated due to limited sample size (n\<3).
|
Adverse Events
MEDI3617 + PACLITAXEL TOTAL
MEDI3617 SINGLE AGENT TOTAL
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
MEDI3617 + BEVACIZUMAB Q2W TOTAL
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
Serious adverse events
| Measure |
MEDI3617 + PACLITAXEL TOTAL
n=13 participants at risk
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 SINGLE AGENT TOTAL
n=42 participants at risk
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 participants at risk
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 participants at risk
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 participants at risk
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Cardiac disorders
Cardiac arrest
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Asthenia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Medical device pain
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Oedema
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Oedema peripheral
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Pyrexia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Infections and infestations
Abscess limb
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Infections and infestations
Meningitis
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Infections and infestations
Pneumonia
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Blood creatinine increased
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Ejection fraction decreased
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Troponin increased
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Weight increased
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Aphasia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Ataxia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Cognitive disorder
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Encephalopathy
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Memory impairment
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Seizure
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Psychiatric disorders
Confusional state
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
9.5%
4/42 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Vascular disorders
Deep vein thrombosis
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Vascular disorders
Embolism
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Vascular disorders
Haematoma
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Vascular disorders
Hypertension
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
Other adverse events
| Measure |
MEDI3617 + PACLITAXEL TOTAL
n=13 participants at risk
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 SINGLE AGENT TOTAL
n=42 participants at risk
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
n=16 participants at risk
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
|
MEDI3617 + BEVACIZUMAB Q2W TOTAL
n=38 participants at risk
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
|
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
n=7 participants at risk
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
9.5%
4/42 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.6%
2/7 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Cardiac disorders
Atrial fibrillation
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Eye disorders
Vision blurred
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
16.7%
7/42 • Number of events 7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Ascites
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • Number of events 6 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
38.1%
16/42 • Number of events 19 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
56.2%
9/16 • Number of events 12 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
10.5%
4/38 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Diarrhoea
|
30.8%
4/13 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
19.0%
8/42 • Number of events 11 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
31.2%
5/16 • Number of events 7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
16.7%
7/42 • Number of events 7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
9.5%
4/42 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Nausea
|
30.8%
4/13 • Number of events 6 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
26.2%
11/42 • Number of events 13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
50.0%
8/16 • Number of events 14 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.9%
11/38 • Number of events 13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
57.1%
4/7 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Gastrointestinal disorders
Vomiting
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
26.2%
11/42 • Number of events 14 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
31.2%
5/16 • Number of events 8 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.6%
2/7 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Chills
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
9.5%
4/42 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Fatigue
|
38.5%
5/13 • Number of events 6 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
42.9%
18/42 • Number of events 26 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
62.5%
10/16 • Number of events 13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
31.6%
12/38 • Number of events 13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
42.9%
3/7 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Mucosal inflammation
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Oedema peripheral
|
30.8%
4/13 • Number of events 7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
26.2%
11/42 • Number of events 15 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 12 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
18.4%
7/38 • Number of events 16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
General disorders
Pyrexia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Immune system disorders
Drug hypersensitivity
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
18.8%
3/16 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
1/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Blood creatinine increased
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.7%
1/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Investigations
Weight increased
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
19.0%
8/42 • Number of events 11 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 15 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
1/13 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
19.0%
8/42 • Number of events 11 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
31.2%
5/16 • Number of events 6 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
13.2%
5/38 • Number of events 7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 6 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 8 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.7%
1/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
42.9%
3/7 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
25.0%
4/16 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
18.8%
3/16 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
19.0%
8/42 • Number of events 8 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
25.0%
4/16 • Number of events 9 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
1/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
50.0%
8/16 • Number of events 10 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
10.5%
4/38 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Ataxia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 6 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
31.0%
13/42 • Number of events 14 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
43.8%
7/16 • Number of events 10 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
9.5%
4/42 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
16.7%
7/42 • Number of events 8 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
25.0%
4/16 • Number of events 6 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
18.4%
7/38 • Number of events 8 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Neuropathy peripheral
|
30.8%
4/13 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
9.5%
4/42 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.9%
3/38 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
25.0%
4/16 • Number of events 6 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Psychiatric disorders
Depression
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
18.8%
3/16 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
25.0%
4/16 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
10.5%
4/38 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
13.2%
5/38 • Number of events 14 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
21.4%
9/42 • Number of events 9 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
25.0%
4/16 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
9.5%
4/42 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.1%
3/13 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
21.4%
9/42 • Number of events 12 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
18.8%
3/16 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
10.5%
4/38 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
15.4%
2/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/42 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.6%
2/7 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
23.1%
3/13 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
9.5%
4/42 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
5.3%
2/38 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.1%
3/13 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.4%
1/42 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
7.7%
1/13 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
6.2%
1/16 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
4.8%
2/42 • Number of events 2 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
12.5%
2/16 • Number of events 4 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/38 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/7 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/13 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
7.1%
3/42 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
0.00%
0/16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
2.6%
1/38 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
14.3%
1/7 • Number of events 1 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
|
Vascular disorders
Hypertension
|
23.1%
3/13 • Number of events 3 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
23.8%
10/42 • Number of events 12 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
37.5%
6/16 • Number of events 24 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
34.2%
13/38 • Number of events 16 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
28.6%
2/7 • Number of events 5 • From start of study drug administration up to 90 days after the last dose of MEDI3617
|
Additional Information
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" in the agreement description.
- Publication restrictions are in place
Restriction type: OTHER