Trial Outcomes & Findings for Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer (NCT NCT02187991)

Last Updated: 2024-10-09

Results Overview

Measurement of tumors (sum of longest diameters) every 8 weeks for CT/MRI and photographs, and every 12 weeks for bone scan, if applicable. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (plus an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

169 participants

Primary outcome timeframe

until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 3 years from date of patient registration

Results posted on

2024-10-09

Participant Flow

Between February 2015 and February 2018, a total of 169\* women were enrolled in the trial and were randomly assigned to paclitaxel alone (85 patients), or paclitaxel plus alisertib (84 patients) cohorts. \*174 women were consented and included in baseline demographics. However, 5 of these did not start study treatment due to ineligibility, participant withdrawal, and/or investigator decision, so only 169 participants were included in Participant Flow and AE/SAE analysis.

Participant milestones

Participant milestones
Measure	ER+/HER2- Paclitaxel Alone Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	ER+/HER2- Paclitaxel Plus Alisertib Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle	Triple Negative Paclitaxel Alone Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	Triple Negative Paclitaxel Plus Alisertib Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle
Overall Study STARTED	70	66	15	18
Overall Study COMPLETED	36	38	8	10
Overall Study NOT COMPLETED	34	28	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	ER+/HER2- Paclitaxel Alone Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	ER+/HER2- Paclitaxel Plus Alisertib Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle	Triple Negative Paclitaxel Alone Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	Triple Negative Paclitaxel Plus Alisertib Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle
Overall Study Adverse Event	13	14	3	2
Overall Study Withdrawal by Subject	9	6	3	2
Overall Study Physician Decision	4	4	0	2
Overall Study Other, unrelated complication	7	1	1	2
Overall Study Death	1	3	0	0

Baseline Characteristics

Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ER+/HER2- Paclitaxel Alone n=70 Participants Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	ER+/HER2- Paclitaxel Plus Alisertib n=69 Participants Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle	Triple Negative Paclitaxel Alone n=16 Participants Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	Triple Negative Paclitaxel Plus Alisertib n=19 Participants Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle	Total n=174 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	31 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	66 Participants n=21 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	38 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	108 Participants n=21 Participants
Age, Continuous	63.2 years n=5 Participants	62.5 years n=7 Participants	65.2 years n=5 Participants	63.2 years n=4 Participants	63.2 years n=21 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	69 Participants n=7 Participants	16 Participants n=5 Participants	19 Participants n=4 Participants	174 Participants n=21 Participants
Sex: Female, Male Male	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
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	23 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	55 Participants n=5 Participants	54 Participants n=7 Participants	9 Participants n=5 Participants	13 Participants n=4 Participants	131 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment United States	70 Participants n=5 Participants	69 Participants n=7 Participants	16 Participants n=5 Participants	19 Participants n=4 Participants	174 Participants n=21 Participants
Positive Nodes 0	36 Participants n=5 Participants	33 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	85 Participants n=21 Participants
Positive Nodes 1-3	20 Participants n=5 Participants	20 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	47 Participants n=21 Participants
Positive Nodes 4 or more	9 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	32 Participants n=21 Participants
Positive Nodes Missing	5 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Prior Chemotherapy for Metastatic Disease No prior chemotherapy	48 Participants n=5 Participants	48 Participants n=7 Participants	11 Participants n=5 Participants	13 Participants n=4 Participants	120 Participants n=21 Participants
Prior Chemotherapy for Metastatic Disease 1 prior chemotherapy	22 Participants n=5 Participants	21 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	54 Participants n=21 Participants
Current Histology Ductal	47 Participants n=5 Participants	45 Participants n=7 Participants	11 Participants n=5 Participants	16 Participants n=4 Participants	119 Participants n=21 Participants
Current Histology Lobular	10 Participants n=5 Participants	9 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	20 Participants n=21 Participants
Current Histology Mixed DL	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Current Histology Other	11 Participants n=5 Participants	13 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	30 Participants n=21 Participants
Current Histology Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death, or discontinuation from study for any other reason, up to 3 years from date of patient registration

Population: All 174 participants who consented were included in this Time to Disease Progression outcome analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in Safety Analysis.

Outcome measures

Outcome measures
Measure	ER+/HER2- Paclitaxel Alone n=70 Participants Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	ER+/HER2- Paclitaxel Plus Alisertib n=69 Participants Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle	Triple Negative Paclitaxel Alone n=16 Participants Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	Triple Negative Paclitaxel Plus Alisertib n=19 Participants Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle
Time to Disease Progression - Tumor Response Based on RECIST 1.1 Criteria	7.1 months Interval 3.8 to 10.6	10.2 months Interval 3.8 to 15.7	5.7 months Interval 2.9 to 8.2	9.6 months Interval 6.1 to 22.6

SECONDARY outcome

Timeframe: up to 4 years from date of patient registration

Population: All 174 participants who consented were included in this Overall Survival outcome analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in Safety Analysis.

Time from randomization to death from any cause

Outcome measures

Outcome measures
Measure	ER+/HER2- Paclitaxel Alone n=70 Participants Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	ER+/HER2- Paclitaxel Plus Alisertib n=69 Participants Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle	Triple Negative Paclitaxel Alone n=16 Participants Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	Triple Negative Paclitaxel Plus Alisertib n=19 Participants Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle
Overall Survival	25.1 months Interval 16.0 to 30.5	26.3 months Interval 18.7 to 37.2	12.7 months Interval 6.8 to 23.5	16.0 months Interval 9.6 to 34.0

Adverse Events

ER+/HER2- Paclitaxel Alone

Serious events: 2 serious events

Other events: 69 other events

Deaths: 43 deaths

ER+/HER2- Paclitaxel Plus Alisertib

Serious events: 13 serious events

Other events: 65 other events

Deaths: 39 deaths

Triple Negative Paclitaxel Alone

Serious events: 0 serious events

Other events: 15 other events

Deaths: 14 deaths

Triple Negative Paclitaxel Plus Alisertib

Serious events: 6 serious events

Other events: 18 other events

Deaths: 13 deaths

Serious adverse events

Serious adverse events
Measure	ER+/HER2- Paclitaxel Alone n=70 participants at risk Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	ER+/HER2- Paclitaxel Plus Alisertib n=66 participants at risk Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle	Triple Negative Paclitaxel Alone n=15 participants at risk Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)	Triple Negative Paclitaxel Plus Alisertib n=18 participants at risk Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle Paclitaxel: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm) Alisertib: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	1.5% 1/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	11.1% 2/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Gastrointestinal disorders DIARRHEA	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	4.5% 3/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	5.6% 1/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Infections and infestations SEPSIS	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	1.5% 1/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	11.1% 2/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Infections and infestations INFECTION FUNGAL	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	5.6% 1/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Blood and lymphatic system disorders NEUTROPENIA	1.4% 1/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	3.0% 2/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Blood and lymphatic system disorders PANCYTOPENIA	1.4% 1/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Gastrointestinal disorders NAUSEA	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	1.5% 1/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
General disorders CHEST PAIN	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	1.5% 1/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	1.5% 1/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Respiratory, thoracic and mediastinal disorders EMBOLISM PULMONARY	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	1.5% 1/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Respiratory, thoracic and mediastinal disorders INFECTION RESPIRATORY	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	1.5% 1/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.
Skin and subcutaneous tissue disorders PHOTOSENSITIVITY REACTION	0.00% 0/70 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	1.5% 1/66 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/15 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.	0.00% 0/18 • until 30 days after last dose of patient's study treatment, for up to 2 years from date of registration (enrollment into study). However, mortality data was collected for up to 4 years from date of registration. 174 participants consented to study treatment, were randomized and were included in Overall Survival and All-Cause Mortality analysis. However, 5 of these participants did not start study treatment, so only 169 participants were included in AE/SAE Analysis and Participant Flow.

Other adverse events

Additional Information

Taqi Mohammad

Sarah Cannon Development Innovations, LLC

Phone: 713-870-2175

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60