Trial Outcomes & Findings for A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions (NCT NCT04645797)
NCT ID: NCT04645797
Last Updated: 2025-08-06
Results Overview
Determine the number of patients who have experienced a Dose Limiting Toxicities (DLT) evaluated by the investigator based on CTCAE Severity Grade.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
Until disease progression, or up to approximately 15 months and 18 days, whichever is first
Results posted on
2025-08-06
Participant Flow
Participant milestones
| Measure |
Cohort -1
25 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 1
50 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 2
100 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 3
175 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 4
250 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 5
350 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 6
500 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort -1
25 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 1
50 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 2
100 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 3
175 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 4
250 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 5
350 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
Cohort 6
500 MG once a week for 21 days in subjects with advance colorectal cancer (CRC) with metastases to the liver and to determine the RP2D.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
3
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
Baseline characteristics by cohort
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
n=1 Participants
100 MG once a week
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Age, Continuous
|
50.5 years
n=93 Participants
|
52 years
n=4 Participants
|
52 years
n=27 Participants
|
52 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
1 participants
n=27 Participants
|
11 participants
n=483 Participants
|
|
ECOG Performance Status
|
1 units on a scale
n=93 Participants
|
0.5 units on a scale
n=4 Participants
|
0 units on a scale
n=27 Participants
|
1 units on a scale
n=483 Participants
|
|
Stage at Trial Entry
IVB
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Stage at Trial Entry
IV
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Stage at Trial Entry
IVC
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Current Stage-Tumor (T)
T2
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Current Stage-Tumor (T)
T3
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Current Stage-Tumor (T)
T4a
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Current Stage-Tumor (T)
T4
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Current Stage-Tumor (T)
Unknown
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Current Stage-Metastasis (M)
M1b
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Current Stage-Metastasis (M)
M1
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Primary Tumor Location
Colon, Left
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Primary Tumor Location
Colon, Right
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Primary Tumor Location
Rectal
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Primary Tumor Location
Other
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Colorectal Type
Adenocarcinoma
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Colorectal Type
Mucinous
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Grade at Study Entry
G2
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Grade at Study Entry
GX (grade not assessed)
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Grade at Study Entry
G1
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Grade at Study Entry
Unknown
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Until disease progression, or up to approximately 15 months and 18 days, whichever is firstDetermine the number of patients who have experienced a Dose Limiting Toxicities (DLT) evaluated by the investigator based on CTCAE Severity Grade.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
n=1 Participants
100 MG once a week
|
|---|---|---|---|
|
Determine the Number of Patients With Dose Limiting Toxicities (DLTs)
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)Population: One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection.
Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
100 MG once a week
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of APR003
Cycle 1 Day 1
|
224 ng/mL
Standard Deviation 124
|
158 ng/mL
Standard Deviation 85.4
|
—
|
|
Maximum Concentration (Cmax) of APR003
Cycle 1 Day 15
|
362 ng/mL
Standard Deviation 150
|
148 ng/mL
Standard Deviation 85.4
|
—
|
|
Maximum Concentration (Cmax) of APR003
Cycle 2 Day 1
|
217 ng/mL
Standard Deviation 157
|
121 ng/mL
Standard Deviation 65.3
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)Population: One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection.
Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
100 MG once a week
|
|---|---|---|---|
|
Time-to-maximum Concentration (Tmax) of APR003
Cycle 1 Day 1
|
0.750 hr
Interval 0.5 to 2.0
|
2.00 hr
Interval 0.5 to 2.0
|
—
|
|
Time-to-maximum Concentration (Tmax) of APR003
Cycle 1 Day 15
|
1.00 hr
Interval 0.5 to 1.0
|
2.00 hr
Interval 1.0 to 4.0
|
—
|
|
Time-to-maximum Concentration (Tmax) of APR003
Cycle 2 Day 1
|
1 hr
Interval 0.5 to 4.0
|
2.00 hr
Interval 2.0 to 4.0
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15 (Cycle duration is 21 days)Population: One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection.
Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
100 MG once a week
|
|---|---|---|---|
|
Area Under the Curve (AUC) From Time Zero to 24 hr (AUC0-24) of APR003
Cycle 1 Day 1
|
597 ng*hr/mL
Standard Deviation 209
|
489 ng*hr/mL
Standard Deviation 137
|
—
|
|
Area Under the Curve (AUC) From Time Zero to 24 hr (AUC0-24) of APR003
Cycle 1 Day 15
|
862 ng*hr/mL
Standard Deviation 355
|
412 ng*hr/mL
Standard Deviation 89
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 (Cycle duration is 21 days)Population: One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection.
Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
100 MG once a week
|
|---|---|---|---|
|
AUC From Time Zero to Time Infinity (AUC0-ꝏ) of APR003
|
601 ng*hr/mL
Standard Deviation 212
|
497 ng*hr/mL
Standard Deviation 134
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)Population: One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection.
Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
100 MG once a week
|
|---|---|---|---|
|
AUC Over the Dosing Interval (AUClast) of APR003
Cycle 1 Day 1
|
597 ng*hr/mL
Standard Deviation 209
|
489 ng*hr/mL
Standard Deviation 137
|
—
|
|
AUC Over the Dosing Interval (AUClast) of APR003
Cycle 1 Day 15
|
830 ng*hr/mL
Standard Deviation 330
|
443 ng*hr/mL
Standard Deviation 112
|
—
|
|
AUC Over the Dosing Interval (AUClast) of APR003
Cycle 2 Day 1
|
525 ng*hr/mL
Standard Deviation 370
|
335 ng*hr/mL
Standard Deviation 147
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)Population: One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection.
Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
100 MG once a week
|
|---|---|---|---|
|
Elimination Half-life (T1/2) of APR003
Cycle 1 Day 1
|
4.03 hr
Standard Deviation 0.816
|
4.56 hr
Standard Deviation 1.29
|
—
|
|
Elimination Half-life (T1/2) of APR003
Cycle 1 Day 15
|
1.78 hr
Standard Deviation 0.630
|
1.77 hr
Standard Deviation 0.279
|
—
|
|
Elimination Half-life (T1/2) of APR003
Cycle 2 Day 1
|
1.56 hr
Standard Deviation 0.485
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 (Cycle duration is 21 days)Population: One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection.
Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
100 MG once a week
|
|---|---|---|---|
|
Apparent Volume of Distribution at Steady State After Administration (Vss/F) of APR003
|
265 L
Standard Deviation 102
|
711 L
Standard Deviation 314
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 (Cycle duration is 21 days)Population: One patient in Cohort 1 was dose-reduced after the first dose from 50 MG to 25 MG and was included only in the Cycle 1 Day 1 analysis. The only patient in Cohort 2 was not analyzed due to incomplete blood collection.
Plasma concentration of APR003 was analyzed by a validated liquid chromatography-tandem mass spectrometry assay. Standard PK parameters were determined using non-compartmental methods.
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
100 MG once a week
|
|---|---|---|---|
|
Apparent Total Plasma Clearance (CL/F) of APR003
|
46.0 L/hr
Standard Deviation 15.7
|
105 L/hr
Standard Deviation 23.1
|
—
|
SECONDARY outcome
Timeframe: Until disease progression, or up to approximately 15 months and 18 days, whichever is firstObjective response rate (ORR), defined as the proportion of patients with either a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Outcome measures
| Measure |
Cohort -1
n=6 Participants
25 MG once a week
|
Cohort 1
n=4 Participants
50 MG once a week
|
Cohort 2
n=1 Participants
100 MG once a week
|
|---|---|---|---|
|
Objective Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort -1
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort -1
n=6 participants at risk
25 MG once weekly
|
Cohort 1
n=4 participants at risk
50 MG once weekly
|
Cohort 2
n=1 participants at risk
100 MG once weekly
|
|---|---|---|---|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Number of events 1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression of Colon Cancer
|
16.7%
1/6 • Number of events 1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
16.7%
1/6 • Number of events 1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Injury, poisoning and procedural complications
Post-surgical Pain
|
16.7%
1/6 • Number of events 1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
Other adverse events
| Measure |
Cohort -1
n=6 participants at risk
25 MG once weekly
|
Cohort 1
n=4 participants at risk
50 MG once weekly
|
Cohort 2
n=1 participants at risk
100 MG once weekly
|
|---|---|---|---|
|
General disorders
Chills
|
83.3%
5/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
75.0%
3/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Fever
|
33.3%
2/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
50.0%
2/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Intermittent fever
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Fatigue
|
50.0%
3/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Left chest wall discomfort
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Intermittent low grade fever
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Intermittent fatigue
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Increase thirst
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Intermittent generalized body aches
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Rigors
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Intermittent chills
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Edema bilateral lower extremities
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
General disorders
Intermittent body aches
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
50.0%
2/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Vomiting
|
83.3%
5/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Vomiting Intermittent
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Nausea Intermittent
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Abdominal pain (gas)
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Dark colored diarrhea
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
50.0%
2/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Pancreatitis
|
50.0%
3/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Emesis
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Worsening diarrhea
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Stomach cramps
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Xerostomia
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Mouth sores
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Left upper quadrant abdominal discomfort following meals
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Intermittent abdominal pain
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Gastrointestinal disorders
Epigastric apin
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Musculoskeletal and connective tissue disorders
Intermitten flank pain
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Musculoskeletal and connective tissue disorders
Left flank pain
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Musculoskeletal and connective tissue disorders
Intermittent right flank pain
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Musculoskeletal and connective tissue disorders
Intermittent myalgias
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Musculoskeletal and connective tissue disorders
Bilateral flank pain
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Blood and lymphatic system disorders
Worsening lymphopenia
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Blood and lymphatic system disorders
Intermittent anemia
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Blood and lymphatic system disorders
Anemia of chronic disease
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Positive COVID-10 test (symptomatic)
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Bacterial sinusitis
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Bladder infection
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Left lower extremity cellulitis
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Pyelonephritis
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Oral thrush
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Left upper extremity ringworm
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Chronic UTI
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Infections and infestations
Fever blisters on lower lip
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Investigations
Elevation of creatinine
|
50.0%
3/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Investigations
Weight loss
|
50.0%
3/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Investigations
Intermittent elevation of alkaline phosphatase
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Investigations
Elevated alanine transaminase
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Investigations
AST increased
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion right lung
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Respiratory, thoracic and mediastinal disorders
Residual dry cough
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Immune system disorders
Cytokine release syndrome
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Immune system disorders
Seasonal allergies
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Worsening of colon cancer
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intermittent tumor pain in RUQ/LUQ
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intermittent lower abdominal tumor pain flare
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lower abdominal tumor flare pain
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right-sided pleuritic chest tumor flare reaction
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right upper quadrant tumor pain flare
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain flare
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Skin and subcutaneous tissue disorders
Rash-face
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation of bilateral fingernails
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Vascular disorders
Worsening hypertension
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Vascular disorders
Intermittent hypotension
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Nervous system disorders
Worsening peripheral neuropathy
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Nervous system disorders
Persistent change of taste
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Nervous system disorders
Lightheadedness
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Renal and urinary disorders
Left hydronephrosis
|
33.3%
2/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Renal and urinary disorders
Left ureteral wall thickening
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Renal and urinary disorders
Right hydronephrosis
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Renal and urinary disorders
Intermittent dysuria
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
25.0%
1/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Renal and urinary disorders
Intermittent bilateral renal colic
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Metabolism and nutrition disorders
Worsening diabetes mellitus type 2
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
100.0%
1/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Injury, poisoning and procedural complications
Post surgical pain
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
|
Hepatobiliary disorders
Hyperbilirubinemia (blood bilirubin increased)
|
16.7%
1/6 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/4 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
0.00%
0/1 • Until disease progression, or up to approximately 15 months and 18 days, whichever is first
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the multicenter publication or 12 months after completion of the Study, whichever occurs first, Institution may itself publish the results of its data from the Study. Institution/Principal Investigator shall provide Sponsor/CRO with advance copy of any proposed publication/oral presentation sixty (60) days prior to the planned date of submission/presentation; Sponsor shall have 60 days to review the proposed publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER