Trial Outcomes & Findings for Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma (NCT NCT01051557)
NCT ID: NCT01051557
Last Updated: 2021-07-19
Results Overview
MTD defined as the dose at which fewer than one-third of patients experience a dose limiting toxicity (DLT) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
28 days
Results posted on
2021-07-19
Participant Flow
Participant milestones
| Measure |
1 (Temsirolimus: 15 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
2 (Temsirolimus: 25 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
3 (Temsirolimus: 50 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
4 (Temsirolimus: 75 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
5 (Temsirolimus: 115 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
6 (Temsirolimus: 170 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
6
|
3
|
8
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
6
|
3
|
7
|
6
|
6
|
Reasons for withdrawal
| Measure |
1 (Temsirolimus: 15 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
2 (Temsirolimus: 25 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
3 (Temsirolimus: 50 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
4 (Temsirolimus: 75 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
5 (Temsirolimus: 115 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
6 (Temsirolimus: 170 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
disease progression
|
3
|
3
|
5
|
2
|
4
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
3
|
4
|
Baseline Characteristics
Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma
Baseline characteristics by cohort
| Measure |
1 (Temsirolimus: 15 mg/wk)
n=4 Participants
Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
2 (Temsirolimus: 25 mg/wk)
n=3 Participants
Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
3 (Temsirolimus: 50 mg/wk)
n=6 Participants
Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
4 (Temsirolimus: 75 mg/wk)
n=3 Participants
Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
5 (Temsirolimus: 115 mg/wk)
n=8 Participants
Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
6 (Temsirolimus: 170 mg/wk)
n=6 Participants
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
n=6 Participants
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
32 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
33 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
31 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
8 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
36 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 28 daysMTD defined as the dose at which fewer than one-third of patients experience a dose limiting toxicity (DLT) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
Outcome measures
| Measure |
Treatment (Temsirolimus and Perifosine)
n=36 Participants
PHASE I: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and perifosine PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive temsirolimus and perifosine as in phase I. Some patients may also undergo cytoreductive surgery.
|
2 (Temsirolimus: 25 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
3 (Temsirolimus: 50 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
4 (Temsirolimus: 75 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
5 (Temsirolimus: 115 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
6 (Temsirolimus: 170 mg/wk)
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose of Temsirolimus
|
115 mg/week
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Data were not collect as as study did not progress to Phase II.
Outcome measures
Outcome data not reported
Adverse Events
1 (Temsirolimus: 15 mg/wk)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
2 (Temsirolimus: 25 mg/wk)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 3 deaths
3 (Temsirolimus: 50 mg/wk)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 6 deaths
4 (Temsirolimus: 75 mg/wk)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
5 (Temsirolimus: 115 mg/wk)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 7 deaths
6 (Temsirolimus: 170 mg/wk)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
1 (Temsirolimus: 15 mg/wk)
n=4 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
2 (Temsirolimus: 25 mg/wk)
n=3 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
3 (Temsirolimus: 50 mg/wk)
n=6 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
4 (Temsirolimus: 75 mg/wk)
n=3 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
5 (Temsirolimus: 115 mg/wk)
n=8 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
6 (Temsirolimus: 170 mg/wk)
n=6 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
n=6 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Infections and infestations
Device related infection
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/4 • 5 years
|
66.7%
2/3 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/4 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
1 (Temsirolimus: 15 mg/wk)
n=4 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
2 (Temsirolimus: 25 mg/wk)
n=3 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
3 (Temsirolimus: 50 mg/wk)
n=6 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
4 (Temsirolimus: 75 mg/wk)
n=3 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
5 (Temsirolimus: 115 mg/wk)
n=8 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
6 (Temsirolimus: 170 mg/wk)
n=6 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
n=6 participants at risk
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Anal mucositis
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 3 • 5 years
|
0.00%
0/6 • 5 years
|
|
Investigations
Cholesterol high
|
25.0%
1/4 • Number of events 3 • 5 years
|
66.7%
2/3 • Number of events 6 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
66.7%
2/3 • Number of events 8 • 5 years
|
25.0%
2/8 • Number of events 13 • 5 years
|
50.0%
3/6 • Number of events 6 • 5 years
|
50.0%
3/6 • Number of events 6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
25.0%
1/4 • Number of events 1 • 5 years
|
33.3%
1/3 • Number of events 2 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
33.3%
1/3 • Number of events 5 • 5 years
|
50.0%
4/8 • Number of events 6 • 5 years
|
50.0%
3/6 • Number of events 4 • 5 years
|
50.0%
3/6 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 2 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
66.7%
4/6 • Number of events 9 • 5 years
|
100.0%
3/3 • Number of events 4 • 5 years
|
37.5%
3/8 • Number of events 5 • 5 years
|
66.7%
4/6 • Number of events 6 • 5 years
|
16.7%
1/6 • Number of events 7 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
1/4 • Number of events 2 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
2/6 • Number of events 2 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
66.7%
4/6 • Number of events 5 • 5 years
|
|
Infections and infestations
Papulopustular rash
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
1/4 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
33.3%
1/3 • Number of events 4 • 5 years
|
37.5%
3/8 • Number of events 19 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
33.3%
2/6 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • 5 years
|
33.3%
1/3 • Number of events 4 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
General disorders
Fatigue
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
33.3%
1/3 • Number of events 2 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
33.3%
2/6 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 3 • 5 years
|
33.3%
1/3 • Number of events 2 • 5 years
|
37.5%
3/8 • Number of events 12 • 5 years
|
33.3%
2/6 • Number of events 4 • 5 years
|
33.3%
2/6 • Number of events 12 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
25.0%
2/8 • Number of events 3 • 5 years
|
33.3%
2/6 • Number of events 15 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
50.0%
3/6 • Number of events 8 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
2/6 • Number of events 3 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
33.3%
2/6 • Number of events 5 • 5 years
|
33.3%
2/6 • Number of events 7 • 5 years
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
25.0%
2/8 • Number of events 3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Investigations
White blood cell decreased
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
50.0%
3/6 • Number of events 8 • 5 years
|
33.3%
1/3 • Number of events 2 • 5 years
|
37.5%
3/8 • Number of events 5 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
66.7%
2/3 • Number of events 2 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
33.3%
1/3 • Number of events 2 • 5 years
|
0.00%
0/8 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
33.3%
1/3 • Number of events 1 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 6 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 2 • 5 years
|
|
General disorders
Edema limbs
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders Other, spec
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 2 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/6 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Investigations
CPK increased
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Eye disorders
Eye infection
|
0.00%
0/4 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/6 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/8 • 5 years
|
0.00%
0/6 • 5 years
|
16.7%
1/6 • Number of events 1 • 5 years
|
Additional Information
Dr. Thomas Kaley
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60