Trial Outcomes & Findings for Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer (NCT NCT02324543)
NCT ID: NCT02324543
Last Updated: 2023-07-21
Results Overview
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
28 days
Results posted on
2023-07-21
Participant Flow
Participant milestones
| Measure |
Dose Level 1- Phase 1
Gemcitabine: 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 1a - Phase 1
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 1b - Phase 1
Gemcitabine - 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 2 - Phase 1
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin -15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 3 - Phase 1
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin - 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 60 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Phase 2
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
3
|
4
|
4
|
24
|
|
Overall Study
COMPLETED
|
6
|
6
|
3
|
4
|
4
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1 - Phase 1
n=6 Participants
Gemcitabine: 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 1a - Phase 1
n=6 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 1b - Phase 1
n=3 Participants
Gemcitabine - 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 2 - Phase 1
n=4 Participants
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin -15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 3 - Phase 1
n=4 Participants
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin - 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 60 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Phase 2
n=24 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
26 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Outcome measures
| Measure |
Phase 1
n=23 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Gemcitabine
|
500 mg/m^2
|
PRIMARY outcome
Timeframe: 28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Outcome measures
| Measure |
Phase 1
n=23 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Docetaxel
|
20 mg/m^2
|
PRIMARY outcome
Timeframe: 28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use.
Outcome measures
| Measure |
Phase 1
n=23 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Capecitabine
|
500 mg
|
PRIMARY outcome
Timeframe: 28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Outcome measures
| Measure |
Phase 1
n=23 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Cisplatin
|
20 mg/m^2
|
PRIMARY outcome
Timeframe: 28 daysDose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Outcome measures
| Measure |
Phase 1
n=23 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Irinotecan
|
20 mg/m^2
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: This measure was only assessed for Phase 2. Per protocol, the 6 subjects treated at the MTD (DL1a) during dose escalation (Phase 1) were counted toward the total sample size of 30 subjects for the Phase 2 outcome measure.
OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only)
Outcome measures
| Measure |
Phase 1
n=30 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Overall Survival (OS) Rate at 9 Months
|
57 percentage of participants
Interval 41.0 to 77.0
|
SECONDARY outcome
Timeframe: 43 monthsRR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Outcome measures
| Measure |
Phase 1
n=30 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Response Rate (RR) Using RECIST 1.1 Criteria
|
57 percentage of participants
Interval 37.0 to 75.0
|
SECONDARY outcome
Timeframe: 43 monthsDCR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Outcome measures
| Measure |
Phase 1
n=30 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Disease Control Rate (DCR) Using RECIST 1.1 Criteria
|
87 percentage of participants
Interval 69.0 to 96.0
|
SECONDARY outcome
Timeframe: 5 yearsPFS is defined as the number of months from the date of first dose to disease progression (progressive disease \[PD\] or relapse from complete response \[CR\] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Outcome measures
| Measure |
Phase 1
n=30 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Progression-free Survival (PFS) Using RECIST 1.1 Criteria
|
8.34 Months
Interval 6.34 to
Upper bound confidence interval was not reached.
|
SECONDARY outcome
Timeframe: 5 yearsOS will be measured (in months) from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Outcome measures
| Measure |
Phase 1
n=30 Participants
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|
|
Overall Survival (OS)
|
11.02 Months
Interval 8.54 to 21.09
|
Adverse Events
Dose Level 1 - Phase 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Level 1a - Phase 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Dose Level 1b - Phase 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2 - Phase 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose Level 3 - Phase 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase 2
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1 - Phase 1
n=6 participants at risk
Gemcitabine: 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 1a - Phase 1
n=6 participants at risk
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 1b - Phase 1
n=3 participants at risk
Gemcitabine - 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 2 - Phase 1
n=4 participants at risk
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin -15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 3 - Phase 1
n=4 participants at risk
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin - 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 60 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Phase 2
n=24 participants at risk
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
Other adverse events
| Measure |
Dose Level 1 - Phase 1
n=6 participants at risk
Gemcitabine: 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 1a - Phase 1
n=6 participants at risk
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 1b - Phase 1
n=3 participants at risk
Gemcitabine - 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 2 - Phase 1
n=4 participants at risk
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin -15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Dose Level 3 - Phase 1
n=4 participants at risk
Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin - 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Irinotecan - 60 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
Phase 2
n=24 participants at risk
Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle
Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
4/24 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
70.8%
17/24 • Number of events 17 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
4/6 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
58.3%
14/24 • Number of events 14 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
6/24 • Number of events 6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Diarrhea
|
83.3%
5/6 • Number of events 5 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
100.0%
3/3 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
75.0%
3/4 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
100.0%
4/4 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
70.8%
17/24 • Number of events 17 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
20.8%
5/24 • Number of events 5 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
6/24 • Number of events 6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
12/24 • Number of events 12 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
4/6 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
37.5%
9/24 • Number of events 9 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
General disorders
Edema
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
4/24 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
75.0%
3/4 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
16/24 • Number of events 16 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
General disorders
Fever
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
20.8%
5/24 • Number of events 5 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
General disorders
Sweating
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
Creatinine, increased
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
29.2%
7/24 • Number of events 16 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
37.5%
9/24 • Number of events 9 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
Neutrophil count decreased
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
75.0%
3/4 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
62.5%
15/24 • Number of events 15 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
Platelet count decreased
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
37.5%
9/24 • Number of events 9 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
Weight Loss
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
White blood count decreased
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
75.0%
3/4 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
12/24 • Number of events 12 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
100.0%
4/4 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
8.3%
2/24 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
6/24 • Number of events 6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
83.3%
5/6 • Number of events 5 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
100.0%
3/3 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
75.0%
3/4 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
62.5%
15/24 • Number of events 15 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
4/24 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
8.3%
2/24 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Nervous system disorders
Neuropathy
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
3/6 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
100.0%
3/3 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
62.5%
15/24 • Number of events 15 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
6/24 • Number of events 6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
12.5%
3/24 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
83.3%
5/6 • Number of events 5 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
75.0%
3/4 • Number of events 3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
12/24 • Number of events 12 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
66.7%
4/6 • Number of events 4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
66.7%
2/3 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
8.3%
2/24 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
2/6 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
29.2%
7/24 • Number of events 7 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
8.3%
2/24 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Vascular disorders
Phlebitis
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
50.0%
2/4 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
8.3%
2/24 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
General disorders
Cold Intolerance
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
33.3%
1/3 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
25.0%
1/4 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Early satiety
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
8.3%
2/24 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
8.3%
2/24 • Number of events 2 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
4.2%
1/24 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Gastrointestinal disorders
Tooth sensitivity
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
|
Investigations
Weight gain
|
0.00%
0/6 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
16.7%
1/6 • Number of events 1 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/3 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/4 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
0.00%
0/24 • All adverse events will be collected from the first dose up to 30 days after last dose.
|
Additional Information
Dung Le, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Phone: 443-287-0002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place