Trial Outcomes & Findings for Enzalutamide, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrioid Endometrial Cancer (NCT NCT02684227)
NCT ID: NCT02684227
Last Updated: 2025-03-19
Results Overview
No dose-limiting toxicities were observed during the safety lead-in. Objective tumor response (complete response (CR) + partial response (PR)).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
up to 6.4 years
Results posted on
2025-03-19
Participant Flow
The study was activated on 08/24/2016 and closed to new patient entry on 06/07/2021. The study was completed on 09/27/2023 and all recruitment was done in a medical clinic setting.
Participant milestones
| Measure |
Part A (Safety Lead-In)
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B (Phase II)
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
43
|
|
Overall Study
COMPLETED
|
6
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
12
|
Reasons for withdrawal
| Measure |
Part A (Safety Lead-In)
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B (Phase II)
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
7
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Progressive Disease
|
0
|
2
|
Baseline Characteristics
Enzalutamide, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV or Recurrent Endometrioid Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Part A (Safety Lead-In)
n=7 Participants
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B (Phase II)
n=43 Participants
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Total
n=50 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
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Continuous
|
64.3 years
n=5 Participants
|
61.5 years
n=7 Participants
|
62.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6.4 yearsNo dose-limiting toxicities were observed during the safety lead-in. Objective tumor response (complete response (CR) + partial response (PR)).
Outcome measures
| Measure |
Part A
n=7 Participants
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B
n=43 Participants
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
|---|---|---|
|
Clinical Activity of Combination Enzalutamide, Carboplatin and Paclitaxel Represented as Objective Tumor Response (Complete Response (CR) + Partial Response (PR)).
|
68 percentage of participants
Interval 51.0 to 81.0
|
62 percentage of participants
Interval 44.0 to 78.0
|
PRIMARY outcome
Timeframe: up to 6.4 yearsWe will tabulate the adverse events by grade and relationship to study drug. Participants had at least 1 treatment-related adverse event.
Outcome measures
| Measure |
Part A
n=7 Participants
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B
n=43 Participants
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
|---|---|---|
|
To Determine the Safety and Feasibility of Daily Enzalutamide Given in Combination With Carboplatin and Paclitaxel in Women With Advanced Stage or Recurrent Endometrial Cancer
Deaths (related & unrelated)
|
0 events
|
2 events
|
|
To Determine the Safety and Feasibility of Daily Enzalutamide Given in Combination With Carboplatin and Paclitaxel in Women With Advanced Stage or Recurrent Endometrial Cancer
Reported SAE related to study agents
|
3 events
|
3 events
|
PRIMARY outcome
Timeframe: up to 6.4 yearsOutcome measures
| Measure |
Part A
n=7 Participants
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B
n=43 Participants
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
|---|---|---|
|
Median Duration of Progression-free Survival
|
14.23 months
Interval 10.45 to
Not Estimable. Insufficient number of participants with events.
|
13.27 months
Interval 9.86 to 25.49
|
SECONDARY outcome
Timeframe: up to 6.4 yearsOutcome measures
| Measure |
Part A
n=7 Participants
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B
n=43 Participants
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
|---|---|---|
|
Overall Survival
|
NA months
Not Estimable. Insufficient number of participants with events.
|
36.14 months
Interval 24.87 to
Not Estimable. Insufficient number of participants with events.
|
Adverse Events
Part A (Safety Lead-In)
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B (Phase II)
Serious events: 3 serious events
Other events: 32 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part A (Safety Lead-In)
n=7 participants at risk
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B (Phase II)
n=43 participants at risk
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Platelet count decreased
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Stroke
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
Other adverse events
| Measure |
Part A (Safety Lead-In)
n=7 participants at risk
Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
Part B (Phase II)
n=43 participants at risk
Enzalutamide 160 mg PO daily X21 days alone then Enzalutamide 160 mg PO daily + Paclitaxel 175 mg/m2 on Day 1 + Carboplatin at AUC 5 on Day 1 of each 21 day cycle for 6-9 cycles
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Blood and lymphatic system disorders
Anemia
|
57.1%
4/7 • Number of events 18 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
74.4%
32/43 • Number of events 83 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
42.9%
3/7 • Number of events 3 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
39.5%
17/43 • Number of events 20 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
9.3%
4/43 • Number of events 5 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Anorexia
|
71.4%
5/7 • Number of events 7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
18.6%
8/43 • Number of events 12 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
4.7%
2/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
4.7%
2/43 • Number of events 3 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
9.3%
4/43 • Number of events 5 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Blood bilirubin increased
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 3 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Eye disorders
Blurred vision
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Cardiac disorders
Cardiac disorders - thrombus suspected
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
Chills
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Psychiatric disorders
Confusion
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
4.7%
2/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
25.6%
11/43 • Number of events 12 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Creatinine increased
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Renal and urinary disorders
Cystitis noninfective
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
25.6%
11/43 • Number of events 15 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
25.6%
11/43 • Number of events 11 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
4.7%
2/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
14.0%
6/43 • Number of events 6 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
Edema limbs
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
7.0%
3/43 • Number of events 3 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
Fatigue
|
100.0%
7/7 • Number of events 23 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
51.2%
22/43 • Number of events 34 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
Fever
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Vascular disorders
Flushing
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
4.7%
2/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
General disorder-soreness
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
General disorder-forgetfulness
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
General muscle weakness
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
7.0%
3/43 • Number of events 3 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
4.7%
2/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
7.0%
3/43 • Number of events 3 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Vascular disorders
Hot flashes
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
23.3%
10/43 • Number of events 10 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
9.3%
4/43 • Number of events 7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
16.3%
7/43 • Number of events 12 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 4 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
7.0%
3/43 • Number of events 4 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
9.3%
4/43 • Number of events 6 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
28.6%
2/7 • Number of events 3 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
34.9%
15/43 • Number of events 20 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
20.9%
9/43 • Number of events 14 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
11.6%
5/43 • Number of events 6 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Infections and infestations
Infections and infestations - oral thrush
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Infections and infestations
Infections and infestations - pneumonia
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Investigations - LDH increase
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Investigations - creatinine decrease
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - upper limb
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - joint pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
Malaise
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
4.7%
2/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 4 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
60.5%
26/43 • Number of events 30 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Nervous system disorders - restless leg syndrome
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Neutrophil count decreased
|
42.9%
3/7 • Number of events 12 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
55.8%
24/43 • Number of events 59 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
General disorders
Pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
9.3%
4/43 • Number of events 5 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
4.7%
2/43 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Peripheral motor neuropathy
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
9.3%
4/43 • Number of events 6 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
55.8%
24/43 • Number of events 31 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Platelet count decreased
|
42.9%
3/7 • Number of events 21 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
51.2%
22/43 • Number of events 59 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
9.3%
4/43 • Number of events 4 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 2 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
9.3%
4/43 • Number of events 4 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
11.6%
5/43 • Number of events 5 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Reproductive system and breast disorders
Vaginal itching
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/7 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
0.00%
0/43 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
Weight loss
|
42.9%
3/7 • Number of events 3 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
2.3%
1/43 • Number of events 1 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
|
Investigations
White blood cell decreased
|
28.6%
2/7 • Number of events 5 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
44.2%
19/43 • Number of events 50 • The study was activated on 08/24/2016 and the first patient was consented on 09/13/2016. The study was completed on 03/28/2023 when the last patient was taken off study and the study was terminated on 09/27/2023. Adverse events were reported from baseline until 30 days following the last dose of study treatment given.
NCI CTCAE version 4.03
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place