Trial Outcomes & Findings for A Study of IMC-RON8 in Advanced Solid Tumors (NCT NCT01119456)
NCT ID: NCT01119456
Last Updated: 2019-02-15
Results Overview
The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting \>7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Baseline through end of study treatment (up to 48 weeks)
Results posted on
2019-02-15
Participant Flow
In this dose escalation study, a completed participant was either a participant who completed the initial 4-week treatment cycle (and 2-weeks of observation for specified treatment arms) or one who discontinued therapy, during the same time period, for a narnatumab (IMC-RON8)-related toxicity.
Participant milestones
| Measure |
IMC-RON8 (5 mg/kg qw)
IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met
|
IMC-RON8 (15 mg/kg q2w)
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met
|
IMC-RON8 (20 mg/kg q2w)
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
3
|
13
|
4
|
3
|
3
|
3
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
7
|
3
|
3
|
13
|
4
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
7
|
3
|
3
|
13
|
4
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of IMC-RON8 in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
IMC-RON8 (5 mg/kg qw)
n=7 Participants
IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
n=3 Participants
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
n=3 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
n=4 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w
n=3 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
n=3 Participants
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
n=3 Participants
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
n=13 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 17.2 • n=93 Participants
|
66.0 years
STANDARD_DEVIATION 2.0 • n=4 Participants
|
65.3 years
STANDARD_DEVIATION 9.8 • n=27 Participants
|
70.5 years
STANDARD_DEVIATION 9.1 • n=483 Participants
|
57.7 years
STANDARD_DEVIATION 9.1 • n=36 Participants
|
38.0 years
STANDARD_DEVIATION 13.1 • n=10 Participants
|
67.3 years
STANDARD_DEVIATION 6.0 • n=115 Participants
|
58.7 years
STANDARD_DEVIATION 11.6 • n=40 Participants
|
59.2 years
STANDARD_DEVIATION 13.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
17 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
10 Participants
n=40 Participants
|
22 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
1 participants
n=40 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
1 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
0 participants
n=115 Participants
|
3 participants
n=40 Participants
|
4 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
3 participants
n=483 Participants
|
3 participants
n=36 Participants
|
3 participants
n=10 Participants
|
2 participants
n=115 Participants
|
9 participants
n=40 Participants
|
33 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
0 participants
n=36 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
0 participants
n=40 Participants
|
1 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
13 Participants
n=40 Participants
|
39 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through end of study treatment (up to 48 weeks)Population: Participants who received at least 1 dose of study drug.
The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting \>7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics).
Outcome measures
| Measure |
IMC-RON8
n=39 Participants
IMC-RON8: Escalating doses (up to 40 mg/kg IMC-RON8) administered IV either qw or q2w for each 4-week cycle.
Participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w)
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of IMC-RON8
|
NA mg/kg
Because only 1 DLT was observed in the study, data were insufficient to determine the MTD.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdosePopulation: Participants who received a first and/or fourth or fifth dose of study drug and had evaluable PK samples for Cmax. No participant was analyzed for the geometric mean (%CV) of Cmax after multiple infusions in the 15, 20, 30, and 40 q2w treatment arms.
The Cmax of IMC-RON8 following the first and multiple IV infusions (the fourth infusion for the qw treatment regimen and the fifth infusion for the q2w treatment regimen) is reported. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for Cmax.
Outcome measures
| Measure |
IMC-RON8
n=7 Participants
IMC-RON8: Escalating doses (up to 40 mg/kg IMC-RON8) administered IV either qw or q2w for each 4-week cycle.
Participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
n=3 Participants
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
n=3 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
n=13 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
n=4 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w)
n=3 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
n=3 Participants
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
n=3 Participants
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8
First infusion
|
111 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 31
|
183 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
369 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
437 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
379 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 17
|
506 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 39
|
581 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 7
|
706 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8
Multiple infusions
|
139 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 50
|
263 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 17
|
452 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 29
|
518 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 25
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
\<3 participants. The participants individual value is 560.97.
|
—
|
—
|
NA micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation NA
\<3 participants. The participants individual values were 1055.57 and 711.99.
|
SECONDARY outcome
Timeframe: First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdosePopulation: Participants who received a first and/or fourth or fifth dose of study drug and had evaluable PK samples for AUC(0-tlast) or AUC tau. No participant was analyzed for the geometric mean (%CV) of AUC tau in the 15, 20, 30, and 40 q2w treatment arms.
The AUC from time 0 to the last quantifiable concentration \[AUC(0-tlast)\] of IMC-RON8 following the first IV infusion is reported along with the AUC for 1 dosing interval (AUC tau). Tau = fourth infusion through 168 hours post infusion for the qw regimen and the fifth infusion through 336 hours post infusion for the q2w regimen. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for AUC(0-tlast) or AUC tau.
Outcome measures
| Measure |
IMC-RON8
n=5 Participants
IMC-RON8: Escalating doses (up to 40 mg/kg IMC-RON8) administered IV either qw or q2w for each 4-week cycle.
Participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
n=3 Participants
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
n=3 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
n=12 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
n=4 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w)
n=3 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
n=3 Participants
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
n=3 Participants
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Curve (AUC) of IMC-RON8
AUC(0-tlast)
|
8320 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 63
|
12500 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 14
|
23800 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 37
|
29000 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 30
|
35600 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 22
|
40500 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 87
|
56900 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 34
|
70200 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 25
|
|
PK: Area Under the Curve (AUC) of IMC-RON8
AUC tau
|
10400 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 87
|
19400 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 11
|
31500 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 51
|
29900 micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation 47
|
NA micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation NA
n \<3 participants. The participants individual value was 560.97.
|
—
|
—
|
NA micrograms*hour/milliliter (mcg*h/mL)
Geometric Coefficient of Variation NA
n \<3 participants. The participants individual values were 113000 and 72200.
|
SECONDARY outcome
Timeframe: Prior to first infusion through study completion (up to 52 weeks)Population: Zero participants analyzed. Immunogenicity data were not collected.
An immunogenicity assay for IMC-RON8 was not developed due to the decision to not further develop IMC-RON8 based on preliminary results of this study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to first infusion through 1 hour post last infusion (end of study treatment, up to 48 weeks)Population: Participants who received at least 1 dose of study drug and had tumor tissue samples.
The expression of RON8 was measured in cell membrane/cytoplasm by immunohistochemistry (IHC) methods that incorporated both intensity and distribution of staining. The H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from a minimum score of 0 to a maximum score of 300; the maximum score indicated the strongest expression. Pharmacodynamic samples were collected per protocol and individual sampling times varied depending on the treatment group.
Outcome measures
| Measure |
IMC-RON8
n=3 Participants
IMC-RON8: Escalating doses (up to 40 mg/kg IMC-RON8) administered IV either qw or q2w for each 4-week cycle.
Participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
n=2 Participants
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
n=2 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
n=2 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
n=3 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w)
n=4 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
n=3 Participants
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
n=11 Participants
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics: H-Score of Macrophage-Stimulating 1-Receptor-8 (RON8)
|
80 units on a scale
Interval 50.0 to 125.0
|
45 units on a scale
Interval 0.0 to 90.0
|
60 units on a scale
Interval 0.0 to 120.0
|
95 units on a scale
Interval 50.0 to 140.0
|
133 units on a scale
Interval 40.0 to 160.0
|
40 units on a scale
Interval 0.0 to 120.0
|
40 units on a scale
Interval 20.0 to 94.0
|
120 units on a scale
Interval 0.0 to 200.0
|
SECONDARY outcome
Timeframe: Baseline to measured PD (up to 48 weeks)Population: Participants who received at least 1 dose of study drug.
Response was defined using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v 1.1) criteria. CR was the disappearance of all target and nontarget lesions; and any pathological lymph node (whether target or nontarget) must have had a reduction in short axis to \<10 millimeters (mm) and normalization of tumor marker level of nontarget lesions. The disappearance of any intratumoral arterial enhancement in all target lesions was also required. PR was having at least a 30% decrease in sum of longest diameter of target lesions. PD was having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir and the unequivocal progression of existing nontarget lesions. SD was small changes that did not meet the above criteria.
Outcome measures
| Measure |
IMC-RON8
n=7 Participants
IMC-RON8: Escalating doses (up to 40 mg/kg IMC-RON8) administered IV either qw or q2w for each 4-week cycle.
Participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
n=3 Participants
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
n=3 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
n=4 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
n=3 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w)
n=3 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
n=3 Participants
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
n=13 Participants
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors)
SD
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors)
PD
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
|
Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors)
Unknown
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through study completion (up to 52 weeks)Population: Participants who received at least 1 dose of study drug.
The number of participants who died is reported by cause of death.
Outcome measures
| Measure |
IMC-RON8
n=7 Participants
IMC-RON8: Escalating doses (up to 40 mg/kg IMC-RON8) administered IV either qw or q2w for each 4-week cycle.
Participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
n=3 Participants
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
n=3 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
n=13 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
n=4 Participants
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w)
n=3 Participants
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
n=3 Participants
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
n=3 Participants
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died
Death Due to PD
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died
Death, Cause Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
IMC-RON8 (5 mg/kg qw)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
IMC-RON8 (10 mg/kg qw)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
IMC-RON8 (15 mg/kg qw)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
IMC-RON8 (20 mg/kg qw)
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
IMC-RON8 (15 mg/kg q2w)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
IMC-RON8 (20 mg/kg q2w)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
IMC-RON8 (30 mg/kg q2w)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
IMC-RON8 (40 mg/kg q2w)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IMC-RON8 (5 mg/kg qw)
n=7 participants at risk
IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
n=3 participants at risk
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
n=3 participants at risk
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
n=13 participants at risk
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
n=4 participants at risk
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w)
n=3 participants at risk
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
n=3 participants at risk
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
n=3 participants at risk
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
|
General disorders
Asthenia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
28.6%
2/7 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Nervous system disorders
Convulsion
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Nervous system disorders
Migraine
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
14.3%
1/7 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
Other adverse events
| Measure |
IMC-RON8 (5 mg/kg qw)
n=7 participants at risk
IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (10 mg/kg qw)
n=3 participants at risk
IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg qw)
n=3 participants at risk
IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg qw)
n=13 participants at risk
IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle.
Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (15 mg/kg q2w)
n=4 participants at risk
IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (20 mg/kg q2w)
n=3 participants at risk
IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (30 mg/kg q2w)
n=3 participants at risk
IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
IMC-RON8 (40 mg/kg q2w)
n=3 participants at risk
IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle.
Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Eye disorders
Vision blurred
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
30.8%
4/13 • Number of events 5
|
25.0%
1/4 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
23.1%
3/13 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
38.5%
5/13 • Number of events 6
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
66.7%
2/3 • Number of events 3
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
38.5%
5/13 • Number of events 5
|
25.0%
1/4 • Number of events 2
|
33.3%
1/3 • Number of events 2
|
66.7%
2/3 • Number of events 4
|
0.00%
0/3
|
|
General disorders
Application site reaction
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Asthenia
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Catheter site pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Catheter site related reaction
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Fatigue
|
28.6%
2/7 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
53.8%
7/13 • Number of events 12
|
75.0%
3/4 • Number of events 8
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
|
General disorders
Feeling cold
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Infusion related reaction
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Mucosal inflammation
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Oedema
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
30.8%
4/13 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
42.9%
3/7 • Number of events 3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
General disorders
Suprapubic pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Hepatobiliary disorders
Bile duct obstruction
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Bronchitis
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Candidiasis
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Furuncle
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Skin infection
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Infections and infestations
Viral infection
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Bile output abnormal
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Blood amylase increased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Blood lactate dehydrogenase increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Blood urea increased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Investigations
Lipase increased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Neutrophil count increased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Investigations
Weight decreased
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
2/7 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
38.5%
5/13 • Number of events 9
|
50.0%
2/4 • Number of events 3
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 3
|
33.3%
1/3 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
23.1%
3/13 • Number of events 4
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
23.1%
3/13 • Number of events 3
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 2
|
66.7%
2/3 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
28.6%
2/7 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Nervous system disorders
Aphasia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Cervical cord compression
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Psychiatric disorders
Depression
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Incontinence
|
14.3%
1/7 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/2
|
0.00%
0/3
|
50.0%
1/2 • Number of events 1
|
0.00%
0/10
|
—
0/0
|
0.00%
0/2
|
0.00%
0/1
|
0.00%
0/2
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/5
|
—
0/0
|
0.00%
0/1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
2/7 • Number of events 3
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/4
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/13
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7
|
0.00%
0/3
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER