Trial Outcomes & Findings for Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer (NCT NCT00159484)
NCT ID: NCT00159484
Last Updated: 2026-05-28
Results Overview
To determine the maximum tolerated dose (MTD) of Celebrex in combination with EPO906 in patients with metastatic colorectal cancer. The MTD is the highest dose that produces the desired therapeutic effect without causing unacceptable or dose-limiting side effects.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
75 participants
Primary outcome timeframe
One month
Results posted on
2026-05-28
Participant Flow
Recruitment for this study opened in October 2004 and closed in June 2011. All subjects were seen and treated in the medical clinics at the University of Southern California and Los Angeles General Medical Center.
Participant milestones
| Measure |
Phase I, Dose Level I
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIIa
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
3
|
4
|
7
|
5
|
6
|
9
|
5
|
16
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
3
|
4
|
7
|
5
|
6
|
9
|
5
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I/II Study of Celebrex and EPO906 in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Phase I, Dose Level I
n=6 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
n=6 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
n=3 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
n=4 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIIa
n=7 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
n=5 Participants
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
n=6 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
n=9 Participants
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
n=5 Participants
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
n=16 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
n=8 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59 Years
n=51 Participants
|
50 Years
n=14 Participants
|
59 Years
n=65 Participants
|
56 Years
n=24 Participants
|
59 Years
n=107 Participants
|
52 Years
n=1000 Participants
|
66 Years
|
62 Years
n=204 Participants
|
60 Years
|
58 Years
n=792 Participants
|
53 Years
n=20 Participants
|
57 Years
n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=1000 Participants
|
3 Participants
|
5 Participants
n=204 Participants
|
4 Participants
|
6 Participants
n=792 Participants
|
5 Participants
n=20 Participants
|
38 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=1000 Participants
|
3 Participants
|
4 Participants
n=204 Participants
|
1 Participants
|
10 Participants
n=792 Participants
|
3 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=1000 Participants
|
1 Participants
|
2 Participants
n=204 Participants
|
2 Participants
|
4 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=1000 Participants
|
5 Participants
|
7 Participants
n=204 Participants
|
3 Participants
|
12 Participants
n=792 Participants
|
8 Participants
n=20 Participants
|
59 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
0 Participants
n=204 Participants
|
0 Participants
|
0 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
0 Participants
n=204 Participants
|
0 Participants
|
0 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
2 Participants
n=204 Participants
|
0 Participants
|
1 Participants
n=792 Participants
|
1 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
0 Participants
n=204 Participants
|
0 Participants
|
1 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=1000 Participants
|
1 Participants
|
2 Participants
n=204 Participants
|
2 Participants
|
4 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
0 Participants
n=204 Participants
|
1 Participants
|
1 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=1000 Participants
|
5 Participants
|
5 Participants
n=204 Participants
|
2 Participants
|
9 Participants
n=792 Participants
|
7 Participants
n=20 Participants
|
46 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
0 Participants
n=204 Participants
|
0 Participants
|
0 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=51 Participants
|
6 participants
n=14 Participants
|
3 participants
n=65 Participants
|
4 participants
n=24 Participants
|
7 participants
n=107 Participants
|
5 participants
n=1000 Participants
|
6 participants
|
9 participants
n=204 Participants
|
5 participants
|
16 participants
n=792 Participants
|
8 participants
n=20 Participants
|
75 participants
n=20 Participants
|
|
Site of Primary Tumor
Appendix
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
1 Participants
n=204 Participants
|
0 Participants
|
0 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
|
Site of Primary Tumor
Colon
|
5 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
3 Participants
n=24 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=1000 Participants
|
5 Participants
|
6 Participants
n=204 Participants
|
4 Participants
|
8 Participants
n=792 Participants
|
5 Participants
n=20 Participants
|
51 Participants
n=20 Participants
|
|
Site of Primary Tumor
Rectosigmoid
|
1 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
2 Participants
n=204 Participants
|
1 Participants
|
7 Participants
n=792 Participants
|
3 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
|
Site of Primary Tumor
Rectum
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=1000 Participants
|
1 Participants
|
0 Participants
n=204 Participants
|
0 Participants
|
1 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
|
Karnofsky performance status %
≥90
|
3 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=1000 Participants
|
5 Participants
|
5 Participants
n=204 Participants
|
2 Participants
|
12 Participants
n=792 Participants
|
5 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
|
Karnofsky performance status %
80
|
1 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=1000 Participants
|
0 Participants
|
3 Participants
n=204 Participants
|
3 Participants
|
2 Participants
n=792 Participants
|
3 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
|
Karnofsky performance status %
≤70
|
1 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
0 Participants
|
1 Participants
n=204 Participants
|
0 Participants
|
2 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
|
Karnofsky performance status %
Missing
|
1 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=1000 Participants
|
1 Participants
|
0 Participants
n=204 Participants
|
0 Participants
|
0 Participants
n=792 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: One monthPopulation: The 51 phase I cohort participants were included in this analysis to determine MTD. The 24 phase II cohort participants were not included.
To determine the maximum tolerated dose (MTD) of Celebrex in combination with EPO906 in patients with metastatic colorectal cancer. The MTD is the highest dose that produces the desired therapeutic effect without causing unacceptable or dose-limiting side effects.
Outcome measures
| Measure |
Phase I, Dose Level IIIa
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level I
n=51 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Celebrex in Combination With EPO906
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9 mg/m2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Until 30 days after patient receives last study drug, up to 17 monthsOnce MTD is established we propose to expand the dose level of the MTD to 62 new patients to evaluate whether the addition of Celebrex to EPO906 can reduce the incidence of grade 3-4 diarrhea to 6% or less.
Outcome measures
| Measure |
Phase I, Dose Level IIIa
n=7 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
n=5 Participants
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
n=6 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
n=9 Participants
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
n=5 Participants
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
n=16 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
n=8 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level I
n=6 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
n=6 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
n=3 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
n=4 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Grade 3-4 Diarrhea
|
3 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
13 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Until Patient goes off study, up to 30 monthsTo estimate the time to progression, survival and response rate in patients with metastatic colorectal cancer who failed 5-FU/LV, CPT-11 and/or oxaliplatin based hemotherapy and receive Celebrex in combination with EPO906.
Outcome measures
| Measure |
Phase I, Dose Level IIIa
n=7 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
n=5 Participants
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
n=6 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
n=9 Participants
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
n=5 Participants
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
n=16 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
n=8 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level I
n=6 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
n=6 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
n=3 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
n=4 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival Rate
|
6.2 Months
Interval 1.1 to 7.6
|
8.7 Months
Interval 0.6 to 26.9
|
4.8 Months
Interval 3.1 to 12.4
|
7.3 Months
Interval 3.6 to 23.6
|
8.7 Months
Interval 7.3 to 10.9
|
6.6 Months
Interval 3.2 to 10.3
|
6.1 Months
Interval 3.1 to 22.8
|
3.4 Months
Interval 2.5 to 22.2
|
3.8 Months
Interval 2.8 to 11.5
|
4.7 Months
Interval 1.7 to 5.0
|
2.2 Months
Interval 2.0 to 11.5
|
SECONDARY outcome
Timeframe: Through study completion, up to 30 monthsPopulation: 29 patients were not evaluable for DTL.
To further assess toxicity of this regimen.
Outcome measures
| Measure |
Phase I, Dose Level IIIa
n=7 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
n=9 Participants
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
n=5 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level I
n=9 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
n=10 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
n=7 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
n=8 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Toxicity (DLTs)
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Until Patient DeathPopulation: Due to limited funding, although samples were collected, analysis of samples was ultimately not completed and therefore no data were collected. It was determined that proceeding with the planned biomarker analyses would not be scientifically informative and would not represent an appropriate use of financial and study resources. Samples will not be analyzed in the future.
To investigate whether the molecular biomarkers including protein expression changes from plasma, the expression levels of VEGF, E-cadherin, TP, COX-2, and β-tubulin in tumor tissue associated with clinical outcome for this regimen.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until patient death, up to 30 monthsTo estimate the progression-free survival rate in patients with metastatic colorectal cancer who failed 5-FU/LV, CPT-11 and/or oxaliplatin based hemotherapy and receive Celebrex in combination with EPO906.
Outcome measures
| Measure |
Phase I, Dose Level IIIa
n=7 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
n=5 Participants
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
n=6 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
n=9 Participants
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
n=5 Participants
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
n=16 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
n=8 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level I
n=6 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
n=6 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
n=3 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
n=4 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival Rate
|
4.8 Months
Interval 0.4 to 6.2
|
5.4 Months
Interval 0.6 to 14.9
|
1.1 Months
Interval 1.1 to 12.4
|
4.5 Months
Interval 0.2 to 23.6
|
8.7 Months
Interval 2.7 to 10.9
|
3.1 Months
Interval 1.4 to 7.4
|
1.6 Months
Interval 1.2 to 12.8
|
1.1 Months
Interval 1.1 to 6.9
|
1.1 Months
Interval 0.8 to 3.9
|
1.5 Months
Interval 0.7 to 2.7
|
1.0 Months
Interval 1.0 to 11.5
|
SECONDARY outcome
Timeframe: at baseline and every 2 cycles; up to 30 monthsTo estimate the tumor response rate in patients with metastatic colorectal cancer who failed 5-FU/LV, CPT-11 and/or oxaliplatin based hemotherapy and receive Celebrex in combination with EPO906.
Outcome measures
| Measure |
Phase I, Dose Level IIIa
n=7 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
n=5 Participants
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
n=6 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
n=9 Participants
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
n=5 Participants
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
n=16 Participants
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
n=8 Participants
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level I
n=6 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
n=6 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
n=3 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
n=4 Participants
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Tumor Response Rate
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overall Tumor Response Rate
Stable Disease
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Overall Tumor Response Rate
Progressive Disease
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Overall Tumor Response Rate
Inevaluable/Off Treatment Early
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksPopulation: 16 participants from Phase II, Dose Level Va were included in this analysis.
Participants in phase II experienced DLTs at 11 mg/m2 MTD, so the dose was reduced to 9mg/m2.
Outcome measures
| Measure |
Phase I, Dose Level IIIa
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level I
n=16 Participants
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With DLTs in Phase II
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16 Participants
|
—
|
—
|
—
|
Adverse Events
Phase I, Dose Level I
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I, Dose Level II
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I, Dose Level Ia
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I, Dose Level IIa
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase I, Dose Level IIIa
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase I, Dose Level IVa
Serious events: 4 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase I, Dose Level Va
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase I, Dose Level VIa
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase I, Dose Level VIIa
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase II, Dose Level Va
Serious events: 16 serious events
Other events: 16 other events
Deaths: 0 deaths
Phase II, Dose Level IIIa
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I, Dose Level I
n=6 participants at risk
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
n=6 participants at risk
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
n=3 participants at risk
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
n=4 participants at risk
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIIa
n=7 participants at risk
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
n=5 participants at risk
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
n=6 participants at risk
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
n=9 participants at risk
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
n=5 participants at risk
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
n=16 participants at risk
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
n=8 participants at risk
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Death not associated with CTCAE term (Death NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
General disorders
Death not associated with CTCAE term (Disease progression NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
12.5%
2/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
General disorders
Death not associated with CTCAE term (Multi-organ failure)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
18.8%
3/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
50.0%
2/4 • 5 years, 3 months.
|
42.9%
3/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
55.6%
5/9 • 5 years, 3 months.
|
100.0%
5/5 • 5 years, 3 months.
|
81.2%
13/16 • 5 years, 3 months.
|
37.5%
3/8 • 5 years, 3 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
33.3%
2/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
28.6%
2/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
22.2%
2/9 • 5 years, 3 months.
|
80.0%
4/5 • 5 years, 3 months.
|
37.5%
6/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
2/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
28.6%
2/7 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
80.0%
4/5 • 5 years, 3 months.
|
18.8%
3/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
16.7%
1/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain (Muscle)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Infections and infestations
Infection with unknown ANC (Small bowel NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
37.5%
6/16 • 5 years, 3 months.
|
50.0%
4/8 • 5 years, 3 months.
|
|
Nervous system disorders
Neuropathy: sensory
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Obstruction, GI (Colon)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
16.7%
1/6 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Nervous system disorders
Pain (Chest/thorax NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
43.8%
7/16 • 5 years, 3 months.
|
37.5%
3/8 • 5 years, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pain (Pleura)
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Perforation, GI (Small bowel NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Endocrine disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Investigations
Alkaline phosphatase
|
16.7%
1/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
75.0%
3/4 • 5 years, 3 months.
|
28.6%
2/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Hemorrhage, GI (Duodenum)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
Other adverse events
| Measure |
Phase I, Dose Level I
n=6 participants at risk
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level II
n=6 participants at risk
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Ia
n=3 participants at risk
EPO906 7mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIa
n=4 participants at risk
EPO906 8mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IIIa
n=7 participants at risk
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level IVa
n=5 participants at risk
EPO906 10mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level Va
n=6 participants at risk
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIa
n=9 participants at risk
EPO906 12mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase I, Dose Level VIIa
n=5 participants at risk
EPO906 13mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level Va
n=16 participants at risk
EPO906 11mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
Phase II, Dose Level IIIa
n=8 participants at risk
EPO906 9mg/m2 (IV) in combination with celecoxib 400mg (oral)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Alkaline phosphatase
|
83.3%
5/6 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
66.7%
2/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
71.4%
5/7 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
44.4%
4/9 • 5 years, 3 months.
|
80.0%
4/5 • 5 years, 3 months.
|
62.5%
10/16 • 5 years, 3 months.
|
50.0%
4/8 • 5 years, 3 months.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
22.2%
2/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
28.6%
2/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
22.2%
2/9 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
43.8%
7/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Renal and urinary disorders
Creatinine
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
3/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
12.5%
2/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
100.0%
3/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
42.9%
3/7 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
83.3%
5/6 • 5 years, 3 months.
|
44.4%
4/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
18.8%
3/16 • 5 years, 3 months.
|
50.0%
4/8 • 5 years, 3 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
50.0%
2/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
31.2%
5/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
12.5%
2/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
General disorders
Edema:limb
|
33.3%
2/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
50.0%
3/6 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
100.0%
3/3 • 5 years, 3 months.
|
100.0%
4/4 • 5 years, 3 months.
|
71.4%
5/7 • 5 years, 3 months.
|
100.0%
5/5 • 5 years, 3 months.
|
66.7%
4/6 • 5 years, 3 months.
|
55.6%
5/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
50.0%
8/16 • 5 years, 3 months.
|
37.5%
3/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) (Oral cavity)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
28.6%
2/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
66.7%
2/3 • 5 years, 3 months.
|
75.0%
3/4 • 5 years, 3 months.
|
100.0%
7/7 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
83.3%
5/6 • 5 years, 3 months.
|
55.6%
5/9 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
25.0%
4/16 • 5 years, 3 months.
|
37.5%
3/8 • 5 years, 3 months.
|
|
Nervous system disorders
Neuropathy: sensory
|
50.0%
3/6 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
75.0%
3/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
66.7%
4/6 • 5 years, 3 months.
|
33.3%
3/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
62.5%
10/16 • 5 years, 3 months.
|
25.0%
2/8 • 5 years, 3 months.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
43.8%
7/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Obstruction, GI (Small bowel NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
General disorders
Pain - Other (Specify, __)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
83.3%
5/6 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
66.7%
2/3 • 5 years, 3 months.
|
75.0%
3/4 • 5 years, 3 months.
|
57.1%
4/7 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
44.4%
4/9 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
68.8%
11/16 • 5 years, 3 months.
|
75.0%
6/8 • 5 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain (Chest wall)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
General disorders
Pain (Chest/thorax NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Eye disorders
Pain (Eye)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Nervous system disorders
Pain (Head/headache)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
18.8%
3/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
16.7%
1/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
66.7%
2/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
3/9 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
25.0%
4/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain (Neck)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Hepatobiliary disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
16.7%
1/6 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
50.0%
2/4 • 5 years, 3 months.
|
28.6%
2/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
3/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
25.0%
4/16 • 5 years, 3 months.
|
37.5%
3/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
2/6 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
75.0%
3/4 • 5 years, 3 months.
|
71.4%
5/7 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
83.3%
5/6 • 5 years, 3 months.
|
77.8%
7/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
50.0%
8/16 • 5 years, 3 months.
|
75.0%
6/8 • 5 years, 3 months.
|
|
Hepatobiliary disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
50.0%
3/6 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
66.7%
2/3 • 5 years, 3 months.
|
50.0%
2/4 • 5 years, 3 months.
|
71.4%
5/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
22.2%
2/9 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
31.2%
5/16 • 5 years, 3 months.
|
62.5%
5/8 • 5 years, 3 months.
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
50.0%
2/4 • 5 years, 3 months.
|
42.9%
3/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
25.0%
4/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Blood and lymphatic system disorders
Platelets
|
16.7%
1/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
22.2%
2/9 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
25.0%
4/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
22.2%
2/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
37.5%
3/8 • 5 years, 3 months.
|
|
General disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
12.5%
2/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
12.5%
2/16 • 5 years, 3 months.
|
25.0%
2/8 • 5 years, 3 months.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia (Sinus tachycardia)
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
22.2%
2/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Ulcer, GI (Colon)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Infections and infestations
Infection with unknown ANC (Urinary tract NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Psychiatric disorders
Mood alteration (Depression)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Nervous system disorders
Insomnia
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Endocrine disorders
Magnesium, serum-low (hypomagnesemia)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Psychiatric disorders
Mood alteration (Agitation)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Psychiatric disorders
Mood alteration (Anxiety)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
18.8%
3/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
6.2%
1/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
6/6 • 5 years, 3 months.
|
50.0%
3/6 • 5 years, 3 months.
|
66.7%
2/3 • 5 years, 3 months.
|
100.0%
4/4 • 5 years, 3 months.
|
100.0%
7/7 • 5 years, 3 months.
|
100.0%
5/5 • 5 years, 3 months.
|
83.3%
5/6 • 5 years, 3 months.
|
88.9%
8/9 • 5 years, 3 months.
|
80.0%
4/5 • 5 years, 3 months.
|
81.2%
13/16 • 5 years, 3 months.
|
87.5%
7/8 • 5 years, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory (Nose)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
14.3%
1/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
11.1%
1/9 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
18.8%
3/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils (Urinary tract NOS)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/3 • 5 years, 3 months.
|
0.00%
0/4 • 5 years, 3 months.
|
0.00%
0/7 • 5 years, 3 months.
|
20.0%
1/5 • 5 years, 3 months.
|
0.00%
0/6 • 5 years, 3 months.
|
0.00%
0/9 • 5 years, 3 months.
|
0.00%
0/5 • 5 years, 3 months.
|
0.00%
0/16 • 5 years, 3 months.
|
0.00%
0/8 • 5 years, 3 months.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
100.0%
4/4 • 5 years, 3 months.
|
42.9%
3/7 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
44.4%
4/9 • 5 years, 3 months.
|
60.0%
3/5 • 5 years, 3 months.
|
37.5%
6/16 • 5 years, 3 months.
|
12.5%
1/8 • 5 years, 3 months.
|
|
General disorders
Weight loss
|
0.00%
0/6 • 5 years, 3 months.
|
16.7%
1/6 • 5 years, 3 months.
|
33.3%
1/3 • 5 years, 3 months.
|
25.0%
1/4 • 5 years, 3 months.
|
42.9%
3/7 • 5 years, 3 months.
|
40.0%
2/5 • 5 years, 3 months.
|
33.3%
2/6 • 5 years, 3 months.
|
44.4%
4/9 • 5 years, 3 months.
|
80.0%
4/5 • 5 years, 3 months.
|
50.0%
8/16 • 5 years, 3 months.
|
37.5%
3/8 • 5 years, 3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place