Trial Outcomes & Findings for BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study (NCT NCT02550743)
NCT ID: NCT02550743
Last Updated: 2021-03-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
approximately 6 weeks
Results posted on
2021-03-12
Participant Flow
Participant milestones
| Measure |
Dose 1
BYL719, capectabine and radiation Dose: 200mg/day
BYL719
Capecitabine
Radiation
|
Dose 2
BYL719, capectabine and radiation Dose: 250mg/day
BYL719
Capecitabine
Radiation
|
Dose 3
BYL719, capectabine and radiation Dose: 300mg/day
BYL719
Capecitabine
Radiation
|
Dose -1
BYL719, capectabine and radiation Dose: 150mg/day
BYL719
Capecitabine
Radiation
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
1
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study
Baseline characteristics by cohort
| Measure |
Dose 1
n=3 Participants
BYL719, capectabine and radiation Dose: 200mg/day
BYL719
Capecitabine
Radiation
|
Dose 2
n=3 Participants
BYL719, capectabine and radiation Dose: 250mg/day
BYL719
Capecitabine
Radiation
|
Dose 3
n=1 Participants
BYL719, capectabine and radiation Dose: 300mg/day
BYL719
Capecitabine
Radiation
|
Dose -1
BYL719, capectabine and radiation Dose: 150mg/day
BYL719
Capecitabine
Radiation
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
43 years
n=99 Participants
|
50 years
n=107 Participants
|
54 years
n=206 Participants
|
—
|
47.6 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Unkown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: approximately 6 weeksOutcome measures
| Measure |
Maximum Tolerated Dose of BYL719
n=7 Participants
BYL719, capectabine and radiation
|
Dose 2
BYL719, capectabine and radiation Dose: 250mg/day
BYL719
Capecitabine
Radiation
|
Dose 3
BYL719, capectabine and radiation Dose: 300mg/day
BYL719
Capecitabine
Radiation
|
Dose -1
BYL719, capectabine and radiation Dose: 150mg/day
BYL719
Capecitabine
Radiation
|
|---|---|---|---|---|
|
Maximum Tolerated Dose of BYL719
|
NA mg
insufficient number of participants with events to determine MTD
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6-10 weeks post treatmentPopulation: No patients enrolled on dose -1.
Pathologic complete response is defined as the lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy.
Outcome measures
| Measure |
Maximum Tolerated Dose of BYL719
n=3 Participants
BYL719, capectabine and radiation
|
Dose 2
n=3 Participants
BYL719, capectabine and radiation Dose: 250mg/day
BYL719
Capecitabine
Radiation
|
Dose 3
n=1 Participants
BYL719, capectabine and radiation Dose: 300mg/day
BYL719
Capecitabine
Radiation
|
Dose -1
BYL719, capectabine and radiation Dose: 150mg/day
BYL719
Capecitabine
Radiation
|
|---|---|---|---|---|
|
Pathologic Complete Response for Patients With Rectal Cancer
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose -1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose 1
n=3 participants at risk
BYL719, capectabine and radiation Dose: 200mg/day
BYL719
Capecitabine
Radiation
|
Dose 2
n=3 participants at risk
BYL719, capectabine and radiation Dose: 250mg/day
BYL719
Capecitabine
Radiation
|
Dose 3
n=1 participants at risk
BYL719, capectabine and radiation Dose: 300mg/day
BYL719
Capecitabine
Radiation
|
Dose -1
BYL719, capectabine and radiation Dose: 150mg/day
BYL719
Capecitabine
Radiation
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
Other adverse events
| Measure |
Dose 1
n=3 participants at risk
BYL719, capectabine and radiation Dose: 200mg/day
BYL719
Capecitabine
Radiation
|
Dose 2
n=3 participants at risk
BYL719, capectabine and radiation Dose: 250mg/day
BYL719
Capecitabine
Radiation
|
Dose 3
n=1 participants at risk
BYL719, capectabine and radiation Dose: 300mg/day
BYL719
Capecitabine
Radiation
|
Dose -1
BYL719, capectabine and radiation Dose: 150mg/day
BYL719
Capecitabine
Radiation
|
|---|---|---|---|---|
|
General disorders
anemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
dehydration
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
diarrhea
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
3/3 • Number of events 3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
erythema multiforme
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
flatulence
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Investigations
FPG-hyperglycemia
|
100.0%
3/3 • Number of events 3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
headache
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
HTN
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Blood and lymphatic system disorders
hypokalemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Blood and lymphatic system disorders
hyponatremia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
3/3 • Number of events 3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
3/3 • Number of events 3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
pain abdominal
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
pain rectal
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Reproductive system and breast disorders
pain vaginal
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Renal and urinary disorders
urinary incontinence
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Eye disorders
watering eyes
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
Dermatitis Radiation
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Metabolism and nutrition disorders
weight loss
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Musculoskeletal and connective tissue disorders
peripheral sensory neuropathy
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Blood and lymphatic system disorders
ALT
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
chills
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
vomit
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
edema
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Blood and lymphatic system disorders
hypoglycemia
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Blood and lymphatic system disorders
hypermagnesium
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
pain perineal
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Reproductive system and breast disorders
vaginal inflammation
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
GI disorders other: rectal inflammation
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
infection
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
pelvic pain
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
Gastrointestinal disorders
Ileus
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
|
General disorders
hematoma
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/3 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
0.00%
0/1 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
—
0/0 • Adverse events were collected from time of consent through 30-days post treatment, an average of 3 months
No patients were enrolled to dose -1.
|
Additional Information
Howard Safran, MD, Principal Investigator
Brown University Oncology Research Group (BrUOG)
Phone: 14018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place