Trial Outcomes & Findings for New Individualized Therapy Trial for Metastatic Colorectal Cancer (NCT NCT00867334)
NCT ID: NCT00867334
Last Updated: 2020-06-30
Results Overview
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected and recorded.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From consent up until 4 weeks after patient has stopped study participation
Results posted on
2020-06-30
Participant Flow
Patients were enrolled at community hospital.
Inclusion and exclusion criteria for the study were rigid, with only 10 patients of 39 screens being able to enroll. Of these 10 patients, 3 were subsequent withdraws occurring after enrollment of various reasons, thus did not wish to continue to participate in the study.
Participant milestones
| Measure |
Treatment With Increasing Doses of Imatinib
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.
|
Standard of Care Therapy With Panitumumab
Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Treatment With Increasing Doses of Imatinib
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.
|
Standard of Care Therapy With Panitumumab
Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
New Individualized Therapy Trial for Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment With Increasing Doses of Imatinib
n=6 Participants
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.
|
Standard of Care Therapy With Panitumumab
n=1 Participants
Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
72 years
STANDARD_DEVIATION 0 • n=7 Participants
|
60.6 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From consent up until 4 weeks after patient has stopped study participationPopulation: The subject randomized to the "Standard of Care Therapy with Panitumumab arm" withdrew after randomization, so no data was collected.
Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected and recorded.
Outcome measures
| Measure |
Treatment With Increasing Doses of Imatinib
n=6 Participants
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.
|
Standard of Care Therapy With Panitumumab
Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
|
|---|---|---|
|
Number of Patients With Adverse Events
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeks after baselinePopulation: CT measurements of metastasis were planned through timepoint 3 (24 weeks). One participant only had data at timepoint 1 (8 weeks), so timepoint 1 was chosen as the post-treatment comparison timepoint for all participants. One subject in the imatinib group and one subject in the panitumumab group withdrew before obtaining 8 week evaluations.
Results reported as number of patients with stabilization or reduction in tumor size. Tumor response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) solid tumor response criteria, evaluated by CT.
Outcome measures
| Measure |
Treatment With Increasing Doses of Imatinib
n=5 Participants
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.
|
Standard of Care Therapy With Panitumumab
Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
|
|---|---|---|
|
Number of Participants With Stabilization or Reduction in Tumor Size
|
3 Participants
|
0 Participants
|
Adverse Events
Treatment With Increasing Doses of Imatinib
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Standard of Care Therapy With Panitumumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment With Increasing Doses of Imatinib
n=6 participants at risk
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.
|
Standard of Care Therapy With Panitumumab
Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Hemorrhage/Bleeding
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Renal and urinary disorders
Renal failure
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Infections and infestations
Infection
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
Other adverse events
| Measure |
Treatment With Increasing Doses of Imatinib
n=6 participants at risk
Subjects whose initial liver biopsy samples meet certain lab values will be placed in Arm 1. Each participant assigned to Arm 1 will receive imatinib mesylate for 28 days, followed by a combination of imatinib mesylate and panitumumab.
All patients in this group then received imatinib mesylate in combination with standard-of-care doses of panitumumab.
|
Standard of Care Therapy With Panitumumab
Patients entering the control arm (Arm 2) received standard of care therapy with panitumumab (6mg/kg every 2 weeks) until tumor progression. Follow up imaging and biopsy were collected 2-3 months from the beginning of treatment.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash or injection site reaction
|
50.0%
3/6 • Number of events 12 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Skin and subcutaneous tissue disorders
Priuritus/itching
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Reproductive system and breast disorders
Hemorrhage GU - Vaginal
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Blood and lymphatic system disorders
Edema
|
66.7%
4/6 • Number of events 9 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Renal and urinary disorders
Infection
|
33.3%
2/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 5 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Weakness
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Generalized aches and pain
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 4 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Dehydration
|
33.3%
2/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Cardiac disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Creatinine
|
16.7%
1/6 • Number of events 8 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Alkaline Phosphatase
|
50.0%
3/6 • Number of events 21 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Alanine aminotransferease
|
50.0%
3/6 • Number of events 8 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Hemoglobin
|
50.0%
3/6 • Number of events 11 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Hepatobiliary disorders
Liver dysfunction
|
16.7%
1/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Total Bilirubin
|
16.7%
1/6 • Number of events 3 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Aspartate aminotransferase
|
33.3%
2/6 • Number of events 6 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Mucositis
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Proteinuria
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Weight loss
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Rigors/chills
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
2/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Hepatobiliary disorders
Hepatomegaly
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Absolute neutrophil count
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Platelets
|
16.7%
1/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Glucose
|
16.7%
1/6 • Number of events 2 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Anal Incontinence
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Renal and urinary disorders
Stool in urine
|
16.7%
1/6 • Number of events 3 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Distension
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Renal and urinary disorders
Fistula - bladder and rectum
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
General disorders
Albumin
|
16.7%
1/6 • Number of events 8 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
|
Blood and lymphatic system disorders
White Blood Count
|
16.7%
1/6 • Number of events 3 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
—
0/0 • Any serious adverse event occurring after the patient has provided informed consent, has started taking the study medication, and until 4 weeks after the patient has stopped study participation.
Note that the subject randomized to the standard of care arm withdrew after randomization, so adverse event data is not available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place