Trial Outcomes & Findings for Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer (NCT NCT00408590)
NCT ID: NCT00408590
Last Updated: 2024-01-16
Results Overview
If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
up to 12 months after last treatment
Results posted on
2024-01-16
Participant Flow
Participant milestones
| Measure |
Cohort 1, Dose Level 1
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 1, these patients received a 10\^3 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 2
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 2, these patients received a 10\^4 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 3
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10\^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 4
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10\^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 5
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10\^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 6
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10\^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 7
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10\^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 2, Dose Level 1
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
Cohort 2, Dose Level 2
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
13
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
3
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=21 Participants
Includes all dose levels of Cohort 1
|
Cohort 2
n=16 Participants
Includes all dose levels of Cohort 2
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
57.5 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
16 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Ascites Present
|
7 participants with ascites
n=5 Participants
|
13 participants with ascites
n=7 Participants
|
20 participants with ascites
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 months after last treatmentPopulation: All patients that received study drug for at least 4 weeks were evaluated for dose limiting toxicities.
If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Includes all dose levels of Cohort 1
|
Cohort 2
n=16 Participants
Includes all dose levels of Cohort 2
|
Cohort 1, Dose Level 3
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10\^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 4
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10\^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 5
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10\^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 6
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10\^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 7
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10\^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 2, Dose Level 1
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
Cohort 2, Dose Level 2
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity
|
0 participants with DLTs
|
0 participants with DLTs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 months after last treatmentResponses will be summarized separately for the MV-CEA virus and MV-NIS virus by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. CA125 levels and time to progression will also be summarized descriptively. Modified Response Evaluation Criteria in Solid Tumors(RECIST v1.0) criteria will be used. For target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter(LD) of target lesions; Progression (PD): As least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Includes all dose levels of Cohort 1
|
Cohort 2
n=16 Participants
Includes all dose levels of Cohort 2
|
Cohort 1, Dose Level 3
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10\^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 4
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10\^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 5
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10\^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 6
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10\^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 7
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10\^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 2, Dose Level 1
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
Cohort 2, Dose Level 2
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Responses (Complete and Partial, Stable and Progressive Disease)
CR
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Responses (Complete and Partial, Stable and Progressive Disease)
PR
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Responses (Complete and Partial, Stable and Progressive Disease)
SD
|
14 participants
|
13 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Responses (Complete and Partial, Stable and Progressive Disease)
PD
|
7 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and up to 18 monthsCA-125 tests are measured in units per milliliter (U/mL) and taken every cycle (up to 6-28 day cycles) during treatment and every three months up to 12 months after treatment. The change in CA-125 is calculated as the baseline CA-125 value subtracted by the last recorded value of CA-125 (up to 18 months from baseline.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Includes all dose levels of Cohort 1
|
Cohort 2
n=1 Participants
Includes all dose levels of Cohort 2
|
Cohort 1, Dose Level 3
n=3 Participants
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10\^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 4
n=2 Participants
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10\^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 5
n=3 Participants
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10\^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 6
n=3 Participants
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10\^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 7
n=3 Participants
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10\^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 2, Dose Level 1
n=3 Participants
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
Cohort 2, Dose Level 2
n=13 Participants
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)
|
-20.2 U/ml
Interval -57.0 to 61.0
|
97 U/ml
Interval 97.0 to 97.0
|
52 U/ml
Interval -26.0 to 4300.0
|
42.5 U/ml
Interval -140.0 to 225.0
|
129 U/ml
Interval 4.0 to 216.0
|
-112 U/ml
Interval -261.0 to -5.0
|
11 U/ml
Interval -8.0 to 21.0
|
1200 U/ml
Interval 6.0 to 2800.0
|
18 U/ml
Interval -447.0 to 3033.0
|
SECONDARY outcome
Timeframe: up to 12 months after last treatmentProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Cohort 1
n=21 Participants
Includes all dose levels of Cohort 1
|
Cohort 2
n=16 Participants
Includes all dose levels of Cohort 2
|
Cohort 1, Dose Level 3
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10\^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 4
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10\^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 5
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10\^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 6
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10\^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 1, Dose Level 7
Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10\^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
|
Cohort 2, Dose Level 1
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
Cohort 2, Dose Level 2
Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10\^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression
|
55 Days
Interval 21.0 to 277.0
|
64.5 Days
Interval 26.0 to 277.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort 2
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=21 participants at risk
Includes all dose levels of Cohort 1
|
Cohort 2
n=16 participants at risk
Includes all dose levels of Cohort 2
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Ascites
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2
|
0.00%
0/16
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
9.5%
2/21 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
2/21 • Number of events 2
|
0.00%
0/16
|
|
General disorders
Edema limbs
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
Peritoneal infection
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
Skin infection
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Investigations
Creatine phosphokinase increased
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Investigations
Creatinine increased
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Anorexia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21 • Number of events 3
|
0.00%
0/16
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Vascular disorders
Thrombosis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
Other adverse events
| Measure |
Cohort 1
n=21 participants at risk
Includes all dose levels of Cohort 1
|
Cohort 2
n=16 participants at risk
Includes all dose levels of Cohort 2
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
28.6%
6/21 • Number of events 8
|
37.5%
6/16 • Number of events 12
|
|
Blood and lymphatic system disorders
Hemolysis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Cardiac disorders
Arrhythmia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Cardiac disorders
Palpitations
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
4.8%
1/21 • Number of events 6
|
0.00%
0/16
|
|
Cardiac disorders
Sinus tachycardia
|
9.5%
2/21 • Number of events 3
|
12.5%
2/16 • Number of events 3
|
|
Ear and labyrinth disorders
Tinnitus
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Endocrine disorders
Endocrine disorder
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Extraocular muscle paresis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Eye disorders
Eye disorder
|
4.8%
1/21 • Number of events 2
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal distension
|
28.6%
6/21 • Number of events 9
|
43.8%
7/16 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain
|
76.2%
16/21 • Number of events 36
|
100.0%
16/16 • Number of events 33
|
|
Gastrointestinal disorders
Ascites
|
4.8%
1/21 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
28.6%
6/21 • Number of events 9
|
37.5%
6/16 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea
|
52.4%
11/21 • Number of events 12
|
56.2%
9/16 • Number of events 15
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
38.1%
8/21 • Number of events 13
|
43.8%
7/16 • Number of events 14
|
|
Gastrointestinal disorders
Gastritis
|
9.5%
2/21 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Mucositis oral
|
9.5%
2/21 • Number of events 3
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
42.9%
9/21 • Number of events 13
|
56.2%
9/16 • Number of events 13
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Stomach pain
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
Vomiting
|
23.8%
5/21 • Number of events 6
|
50.0%
8/16 • Number of events 11
|
|
General disorders
Chest pain
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Chills
|
19.0%
4/21 • Number of events 9
|
56.2%
9/16 • Number of events 20
|
|
General disorders
Edema limbs
|
23.8%
5/21 • Number of events 9
|
25.0%
4/16 • Number of events 4
|
|
General disorders
Fatigue
|
61.9%
13/21 • Number of events 26
|
62.5%
10/16 • Number of events 24
|
|
General disorders
Fever
|
47.6%
10/21 • Number of events 16
|
62.5%
10/16 • Number of events 22
|
|
General disorders
General symptom
|
4.8%
1/21 • Number of events 1
|
12.5%
2/16 • Number of events 3
|
|
General disorders
Injection site reaction
|
4.8%
1/21 • Number of events 2
|
0.00%
0/16
|
|
General disorders
Pain
|
33.3%
7/21 • Number of events 17
|
25.0%
4/16 • Number of events 5
|
|
Infections and infestations
Bladder infection
|
4.8%
1/21 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
Skin infection
|
4.8%
1/21 • Number of events 2
|
0.00%
0/16
|
|
Infections and infestations
Soft tissue infection
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
Wound infection
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Bruising
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
4.8%
1/21 • Number of events 3
|
6.2%
1/16 • Number of events 4
|
|
Investigations
Alkaline phosphatase increased
|
4.8%
1/21 • Number of events 1
|
18.8%
3/16 • Number of events 5
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
3/21 • Number of events 4
|
12.5%
2/16 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/21
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Creatinine increased
|
4.8%
1/21 • Number of events 1
|
12.5%
2/16 • Number of events 5
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/21
|
6.2%
1/16 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
4.8%
1/21 • Number of events 3
|
25.0%
4/16 • Number of events 9
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
4.8%
1/21 • Number of events 5
|
18.8%
3/16 • Number of events 6
|
|
Investigations
Platelet count decreased
|
0.00%
0/21
|
18.8%
3/16 • Number of events 6
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Investigations
Weight gain
|
0.00%
0/21
|
6.2%
1/16 • Number of events 4
|
|
Investigations
Weight loss
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
9/21 • Number of events 14
|
18.8%
3/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
14.3%
3/21 • Number of events 7
|
18.8%
3/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/21
|
6.2%
1/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
23.8%
5/21 • Number of events 5
|
0.00%
0/16
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
9.5%
2/21 • Number of events 2
|
18.8%
3/16 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 11
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.8%
5/21 • Number of events 9
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.5%
2/21 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.0%
4/21 • Number of events 11
|
6.2%
1/16 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 2
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
23.8%
5/21 • Number of events 5
|
18.8%
3/16 • Number of events 6
|
|
Nervous system disorders
Neurological disorder NOS
|
9.5%
2/21 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.8%
1/21 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.8%
1/21 • Number of events 1
|
18.8%
3/16 • Number of events 7
|
|
Nervous system disorders
Speech disorder
|
4.8%
1/21 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Number of events 1
|
12.5%
2/16 • Number of events 3
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Psychiatric disorders
Insomnia
|
14.3%
3/21 • Number of events 3
|
6.2%
1/16 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/21
|
6.2%
1/16 • Number of events 2
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/21
|
6.2%
1/16 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/21
|
12.5%
2/16 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.8%
1/21 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.0%
4/21 • Number of events 4
|
12.5%
2/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
4.8%
1/21 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
3/21 • Number of events 4
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.8%
1/21 • Number of events 3
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.5%
2/21 • Number of events 3
|
12.5%
2/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
14.3%
3/21 • Number of events 5
|
18.8%
3/16 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
4.8%
1/21 • Number of events 2
|
12.5%
2/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/21
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Flushing
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Vascular disorders
Hemorrhage
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
|
Vascular disorders
Hypotension
|
9.5%
2/21 • Number of events 2
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place