Trial Outcomes & Findings for Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer (NCT NCT02457910)
NCT ID: NCT02457910
Last Updated: 2022-08-22
Results Overview
CBR is defined as the proportion of patients with a best response of complete response (CR), partial response (PR), or (SD) stable disease per RECIST criteria 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. It is calculated as the mean of binomial distribution.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
At 16 weeks
Results posted on
2022-08-22
Participant Flow
13 enrolled in Phase Ib and 17 in phase II
13 in phase Ib and 17 in phase II
Participant milestones
| Measure |
PH1b E+T - Level 1 (Cohort 1)
Enzalutamide 160 mg PO daily and 2 mg Taselisib PO daily
|
PH1b E+T - Level 2 (Cohort 1 and 2)
Enzalutamide 160 mg PO daily and Taselisib 4 mg PO daily
|
PH1b E+T - Level 3 (Cohort 1)
Enzalutamide 160 mg PO daily and Taselisib 6 mg PO daily
|
PH1b E+T - Level 4 (Cohort 1)
Enzalutamide 160 mg PO daily and Taselisib 8 mg PO daily
|
PHII Enzalutamide
Enzalutamide 160mg PO daily
|
Phase II E+T
Enzalutamide 160mg PO daily and Taselisib 4 mg PO daily
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
3
|
2
|
5
|
12
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
3
|
2
|
5
|
11
|
Reasons for withdrawal
| Measure |
PH1b E+T - Level 1 (Cohort 1)
Enzalutamide 160 mg PO daily and 2 mg Taselisib PO daily
|
PH1b E+T - Level 2 (Cohort 1 and 2)
Enzalutamide 160 mg PO daily and Taselisib 4 mg PO daily
|
PH1b E+T - Level 3 (Cohort 1)
Enzalutamide 160 mg PO daily and Taselisib 6 mg PO daily
|
PH1b E+T - Level 4 (Cohort 1)
Enzalutamide 160 mg PO daily and Taselisib 8 mg PO daily
|
PHII Enzalutamide
Enzalutamide 160mg PO daily
|
Phase II E+T
Enzalutamide 160mg PO daily and Taselisib 4 mg PO daily
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
1
|
1
|
3
|
|
Overall Study
Disease progression
|
3
|
3
|
1
|
1
|
4
|
6
|
|
Overall Study
Other complicating illness
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
PH1b E+T - Level 1 (Cohort 1)
n=3 Participants
Enzalutamide and Taselisib taken daily by mouth
|
PH1b E+T - Level 2 (Cohort 1 and 2)
n=5 Participants
Enzalutamide and Taselisib taken daily by mouth
|
PH1b E+T - Level 3 (Cohort 1)
n=3 Participants
Enzalutamide and Taselisib taken daily by mouth
|
PH1b E+T - Level 4 (Cohort 1)
n=2 Participants
Enzalutamide and Taselisib taken daily by mouth
|
PHII Enzalutamide
n=5 Participants
Enzalutamide taken daily by mouth
|
Phase II E+T
n=12 Participants
Enzalutamide and Taselisib taken daily by mouth
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
29 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: At 16 weeksPopulation: Evaluable TNBC patients who had at least one cycle of treatment and had their disease re-evaluated at 16 weeks or progressed prior to the 16-week assessment
CBR is defined as the proportion of patients with a best response of complete response (CR), partial response (PR), or (SD) stable disease per RECIST criteria 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. It is calculated as the mean of binomial distribution.
Outcome measures
| Measure |
Arm I (Taselisib, Enzalutamide)
n=14 Participants
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Arm II (Enzalutamide)
n=5 Participants
Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may crossover to Arm I.
|
6mg Taselisib and 160mg Enzalutamide
Patients receive 6mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
8mg Taselisib and 160mg Enzalutamide
Patients receive8mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) - Phase II
|
0.357 proportion of patients
Interval 0.163 to 0.612
|
0 proportion of patients
Interval 0.0 to 0.434
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: 13 patients (7 ER+ and 6 TNBC) breast cancer patients
defined as the highest dose tested in which a dose limiting toxicity is experienced by 0 out of 3 or 1 out of 6 patients among the dose levels. Dose limiting toxicity will be graded according to the National Cancer Institute CTCAE version 4.0.
Outcome measures
| Measure |
Arm I (Taselisib, Enzalutamide)
n=3 Participants
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Arm II (Enzalutamide)
n=5 Participants
Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may crossover to Arm I.
|
6mg Taselisib and 160mg Enzalutamide
n=3 Participants
Patients receive 6mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
8mg Taselisib and 160mg Enzalutamide
n=3 Participants
Patients receive8mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Taselisib Combined With 160mg Enzalutamide - Phase I
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
SECONDARY outcome
Timeframe: Time from course 1, day 1 until objective tumor progression, assessed up to 3 yearsPopulation: Evaluable Androgen Receptor Positive Triple Negative Metastatic Breast Cancer patients that received enzalutamide + taselisib regardless of dose assignment. It is pre-specified by the study protocol to combined groups of TN MBC patients who received both drugs for overall PFS.
The PFS time is defined as the time from treatment start to progression or death (whichever comes first), and those alive without progression were censored at the last date of follow up. PFS will be estimated using the Kaplan-Meier method. The median with 95% confidence intervals will be reported.
Outcome measures
| Measure |
Arm I (Taselisib, Enzalutamide)
n=14 Participants
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Arm II (Enzalutamide)
Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may crossover to Arm I.
|
6mg Taselisib and 160mg Enzalutamide
Patients receive 6mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
8mg Taselisib and 160mg Enzalutamide
Patients receive8mg taselisib PO QD on days 1-28 and 160mg enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
|---|---|---|---|---|
|
Overall Progression-Free Survival (PFS) of Patients Treated With Enzalutamide and Taselisib
|
3.4 months
Interval 2.1 to 7.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 4 monthsPopulation: Data was not collected because taselisib is no longer being developed commercially.
Pharmacokinetic sampling will occur in the phase Ib portion and in 10 patients in the phase II portion
Outcome measures
Outcome data not reported
Adverse Events
Taselisib 2 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Taselisib 4 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
Taselisib 6 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Taselisib 8 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Enzalutamide
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Enzalutamide + Taselisib
Serious events: 10 serious events
Other events: 12 other events
Deaths: 5 deaths
Cross-Over
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Taselisib 2 mg
n=3 participants at risk
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Taselisib 4 mg
n=5 participants at risk
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Taselisib 6 mg
n=3 participants at risk
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Taselisib 8 mg
n=2 participants at risk
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Enzalutamide
n=2 participants at risk
Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may crossover to receive Enzalutamide + Taselisib
|
Enzalutamide + Taselisib
n=12 participants at risk
Patients receive enzalutamide PO QD starting on day 1 of cycle 1, and will receive PO QD Taselisib on day 1 of cycle 2.
|
Cross-Over
n=3 participants at risk
Upon progression of disease, patients on the enzalutamide only arm will be allowed to crossover to enzalutamide + taselisib (must begin no later than 21 days after the clinic visit at which disease progression is determined) Enzalutamide and Taselisib will be taken PO QD
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
General disorders
Fever
|
0.00%
0/3 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
41.7%
5/12 • Number of events 5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
50.0%
6/12 • Number of events 6 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
General disorders
Diarrhea
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Cardiac disorders
Heart failure
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Infections and infestations
Acute appendicitis
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
Other adverse events
| Measure |
Taselisib 2 mg
n=3 participants at risk
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Taselisib 4 mg
n=5 participants at risk
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Taselisib 6 mg
n=3 participants at risk
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Taselisib 8 mg
n=2 participants at risk
Patients receive taselisib PO QD on days 1-28 and enzalutamide PO QD on days 9-28 of course 1 and days 1-28 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to enzalutamide may continue to receive taselisib.
|
Enzalutamide
n=2 participants at risk
Patients receive enzalutamide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may crossover to receive Enzalutamide + Taselisib
|
Enzalutamide + Taselisib
n=12 participants at risk
Patients receive enzalutamide PO QD starting on day 1 of cycle 1, and will receive PO QD Taselisib on day 1 of cycle 2.
|
Cross-Over
n=3 participants at risk
Upon progression of disease, patients on the enzalutamide only arm will be allowed to crossover to enzalutamide + taselisib (must begin no later than 21 days after the clinic visit at which disease progression is determined) Enzalutamide and Taselisib will be taken PO QD
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 3 • Approximately 42 months
|
40.0%
2/5 • Number of events 4 • Approximately 42 months
|
66.7%
2/3 • Number of events 4 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
100.0%
2/2 • Number of events 2 • Approximately 42 months
|
58.3%
7/12 • Number of events 7 • Approximately 42 months
|
100.0%
3/3 • Number of events 3 • Approximately 42 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
80.0%
4/5 • Number of events 9 • Approximately 42 months
|
33.3%
1/3 • Number of events 3 • Approximately 42 months
|
100.0%
2/2 • Number of events 4 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
33.3%
4/12 • Number of events 4 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Gastrointestinal disorders
Vomitting
|
0.00%
0/3 • Approximately 42 months
|
80.0%
4/5 • Number of events 4 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
33.3%
4/12 • Number of events 4 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
66.7%
2/3 • Number of events 3 • Approximately 42 months
|
100.0%
5/5 • Number of events 5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Gastrointestinal disorders
Mucositis oral
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Approximately 42 months
|
40.0%
2/5 • Number of events 2 • Approximately 42 months
|
33.3%
1/3 • Number of events 3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
50.0%
1/2 • Number of events 2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Approximately 42 months
|
100.0%
5/5 • Number of events 15 • Approximately 42 months
|
100.0%
3/3 • Number of events 3 • Approximately 42 months
|
100.0%
2/2 • Number of events 2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
25.0%
3/12 • Number of events 5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 2 • Approximately 42 months
|
50.0%
1/2 • Number of events 2 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
33.3%
4/12 • Number of events 4 • Approximately 42 months
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 2 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 4 • Approximately 42 months
|
100.0%
5/5 • Number of events 12 • Approximately 42 months
|
100.0%
3/3 • Number of events 6 • Approximately 42 months
|
100.0%
2/2 • Number of events 2 • Approximately 42 months
|
100.0%
2/2 • Number of events 7 • Approximately 42 months
|
83.3%
10/12 • Number of events 21 • Approximately 42 months
|
100.0%
3/3 • Number of events 3 • Approximately 42 months
|
|
General disorders
Fever
|
0.00%
0/3 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
50.0%
6/12 • Number of events 10 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
General disorders
Limb edema
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
40.0%
2/5 • Number of events 2 • Approximately 42 months
|
33.3%
1/3 • Number of events 2 • Approximately 42 months
|
100.0%
2/2 • Number of events 4 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
33.3%
4/12 • Number of events 5 • Approximately 42 months
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/3 • Approximately 42 months
|
40.0%
2/5 • Number of events 4 • Approximately 42 months
|
66.7%
2/3 • Number of events 3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 3 • Approximately 42 months
|
66.7%
2/3 • Number of events 3 • Approximately 42 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 2 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
40.0%
2/5 • Number of events 2 • Approximately 42 months
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
16.7%
2/12 • Number of events 4 • Approximately 42 months
|
66.7%
2/3 • Number of events 3 • Approximately 42 months
|
|
Investigations
Alanine amininotransferase increased
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 2 • Approximately 42 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Approximately 42 months
|
60.0%
3/5 • Number of events 3 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
100.0%
2/2 • Number of events 2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
33.3%
1/3 • Number of events 2 • Approximately 42 months
|
|
Investigations
Weight loss
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
20.0%
1/5 • Number of events 2 • Approximately 42 months
|
66.7%
2/3 • Number of events 3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Investigations
White blood cell decreased
|
33.3%
1/3 • Number of events 5 • Approximately 42 months
|
40.0%
2/5 • Number of events 5 • Approximately 42 months
|
33.3%
1/3 • Number of events 3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
33.3%
1/3 • Number of events 2 • Approximately 42 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Approximately 42 months
|
40.0%
2/5 • Number of events 3 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
66.7%
2/3 • Number of events 3 • Approximately 42 months
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 2 • Approximately 42 months
|
40.0%
2/5 • Number of events 2 • Approximately 42 months
|
33.3%
1/3 • Number of events 2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Gastrointestinal disorders
Headache
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
40.0%
2/5 • Number of events 2 • Approximately 42 months
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
33.3%
4/12 • Number of events 5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
50.0%
1/2 • Number of events 2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
16.7%
2/12 • Number of events 3 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
100.0%
5/5 • Number of events 5 • Approximately 42 months
|
100.0%
3/3 • Number of events 3 • Approximately 42 months
|
100.0%
2/2 • Number of events 2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
33.3%
4/12 • Number of events 6 • Approximately 42 months
|
66.7%
2/3 • Number of events 3 • Approximately 42 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Psychiatric disorders
Anxiety
|
66.7%
2/3 • Number of events 4 • Approximately 42 months
|
40.0%
2/5 • Number of events 2 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Psychiatric disorders
Confusion
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
20.0%
1/5 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/12 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
50.0%
1/2 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
66.7%
2/3 • Number of events 2 • Approximately 42 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
8.3%
1/12 • Number of events 1 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 4 • Approximately 42 months
|
40.0%
2/5 • Number of events 4 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 6 • Approximately 42 months
|
33.3%
1/3 • Number of events 1 • Approximately 42 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/5 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
0.00%
0/2 • Approximately 42 months
|
16.7%
2/12 • Number of events 2 • Approximately 42 months
|
0.00%
0/3 • Approximately 42 months
|
Additional Information
Vandana Abramson, MD
Vanderbilt University Medical Center
Phone: (615)936-8422
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place