Trial Outcomes & Findings for Azacitidine and CAPOX in Metastatic Colorectal Cancer (NCT NCT01193517)
NCT ID: NCT01193517
Last Updated: 2020-04-15
Results Overview
Dose just below the one at which ≥ 1/3 of subjects experience a dose limiting toxicity (DLT) considered the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to 3 weeks from the first dose
Results posted on
2020-04-15
Participant Flow
Recruitment Period: August 2010 to August 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Phase I: Starting Dose
Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)
Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
Phase I: Highest Dose Level
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase II
MTD of Azacitidine + CAPOX
Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
11
|
|
Overall Study
COMPLETED
|
2
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I: Starting Dose
Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)
Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
Phase I: Highest Dose Level
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase II
MTD of Azacitidine + CAPOX
Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
|---|---|---|---|
|
Overall Study
Early Progression
|
1
|
0
|
0
|
Baseline Characteristics
Azacitidine and CAPOX in Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Phase I: Starting Dose
n=3 Participants
Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)
Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
Phase I: Highest Dose Level
n=12 Participants
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase II
n=11 Participants
MTD of Azacitidine + CAPOX
Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
18 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
|
Age, Continuous
|
59 years
n=39 Participants
|
56 years
n=41 Participants
|
61 years
n=35 Participants
|
59 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
19 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
12 participants
n=41 Participants
|
11 participants
n=35 Participants
|
26 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeks from the first doseDose just below the one at which ≥ 1/3 of subjects experience a dose limiting toxicity (DLT) considered the MTD.
Outcome measures
| Measure |
Azacitidine+CAPOX (Capecitabine, Oxaliplatin)
n=26 Participants
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase I: Highest Dose Level
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase II
MTD of Azacitidine + CAPOX
Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Azacitidine
|
75 mg/m^2
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Oxaliplatin
|
110 mg/m^2
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
Capecitabine
|
1500 mg/m^2
|
—
|
—
|
SECONDARY outcome
Timeframe: After 9 weeks (three, 21 day cycles)Per Response Evaluation Criteria in solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by CT or MRI: Partial Response (PR), \>= 30%decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither PD nor PR, the sum of the longest diameters no change or increase by \<20% from baseline or from nadir (smallest sum on treatment); Progressive Disease (PD), the sum of the longest diameters increases by\>= 20% from nadir (smallest sum on treatment). For non-target lesions assessed by CT or MRI: Stable Disease (SD), Persistence of \>=1 non-target lesion; Progressive Disease (PD), Enlargement of non-target lesions and/or appearance of new lesions.
Outcome measures
| Measure |
Azacitidine+CAPOX (Capecitabine, Oxaliplatin)
n=3 Participants
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase I: Highest Dose Level
n=12 Participants
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase II
n=11 Participants
MTD of Azacitidine + CAPOX
Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
|---|---|---|---|
|
Response Rate of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
NA (Early Progression)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
PD (Progression Disease)
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Response Rate of Azacitidine, and Capecitabine and Oxaliplatin (CAPOX)
SD (Stable Disease)
|
1 Participants
|
6 Participants
|
10 Participants
|
Adverse Events
Phase I: Starting Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I: Highest Dose Level
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Phase II
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Starting Dose
n=3 participants at risk
Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)
Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
Phase I: Highest Dose Level
n=12 participants at risk
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase II
n=11 participants at risk
MTD of Azacitidine + CAPOX
Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
General disorders
Pain-pelvis
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
Other adverse events
| Measure |
Phase I: Starting Dose
n=3 participants at risk
Dose Escalation of Azacitidine + CAPOX (Capecitabine, Oxaliplatin)
Of 21 day cycle, starting dose Azacitidine 75 mg/m2/day subcutaneously on Days 1-5; Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
Phase I: Highest Dose Level
n=12 participants at risk
Subcutaneous Azacitidine 75 mg/m2/day days 1 to 5, intravenous Oxaliplatin 110 mg/m2 day 2, and oral capecitabine 1500 mg/m2 divided twice daily for 2 weeks every three weeks
|
Phase II
n=11 participants at risk
MTD of Azacitidine + CAPOX
Of a 21 day cycle, Azacitidine MTD (Highest tolerable dose of combination azacitidine with CAPOX found in Phase I); Capecitabine 1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14; and Oxaliplatin starting dose 90 mg/m2 by vein on Day 2.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Alkaline Phasphatase
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
27.3%
3/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
75.0%
9/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
72.7%
8/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
41.7%
5/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
54.5%
6/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Nervous system disorders
Neuropathy Sensory
|
33.3%
1/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
54.5%
6/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Neutrophils
|
66.7%
2/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
58.3%
7/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
63.6%
7/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
1/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
50.0%
6/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
54.5%
6/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
50.0%
6/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
45.5%
5/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
General disorders
Fatigue
|
33.3%
1/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
75.0%
9/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
81.8%
9/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Platelet
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
41.7%
5/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
72.7%
8/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Sodium, Serum-low
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Phosphase, Serum-low
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Potassium, Serum-low
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
27.3%
3/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Magnesium, Serum-low
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
27.3%
3/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Potassium, Serum-High
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
18.2%
2/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
25.0%
3/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
ALT
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
36.4%
4/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
AST
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
58.3%
7/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
36.4%
4/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
58.3%
7/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
63.6%
7/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Nervous system disorders
Neurology Other
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
General disorders
Pain Other-injection site
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
27.3%
3/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Glucose, Serum-high
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Taste Alteration
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
36.4%
4/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
27.3%
3/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
25.0%
3/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
90.9%
10/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Immune system disorders
Flu-like Syndrome
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
25.0%
3/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Infections and infestations
UTI
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
hemorrhage, pulmonary-hemoptysis
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
General disorders
Sweating
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain-Muscle
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Edema-Limbs
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash; Hand-Foot Skin Reaction
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
18.2%
2/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
General disorders
Weight Loss
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
18.2%
2/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
27.3%
3/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other Throat Tightness
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Bilirubin
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
16.7%
2/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
45.5%
5/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash Desquamation
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Eye disorders
Vision-Blurred
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
8.3%
1/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Hemorrhage-Other
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Pain-Abdomen NOS
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
27.3%
3/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
18.2%
2/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Ileus, GI-small Intestine
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Eye disorders
Wartering Eye
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
|
Eye disorders
Ocular/Visual-other
|
0.00%
0/3 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
0.00%
0/12 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
9.1%
1/11 • Adverse event data collected from baseline, during active 21 day cycle treatment and for 30 days after the last dose of study drug
|
Additional Information
Dr. Michael J Overman/ Professor, GI Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place