Trial Outcomes & Findings for Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients (NCT NCT04503668)

Last Updated: 2025-06-18

Results Overview

Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

62 participants

Primary outcome timeframe

120 hours post initiating chemotherapy during cycle 1

Results posted on

2025-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	Nk1-RA Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Overall Study STARTED	31	31
Overall Study COMPLETED	24	27
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Nk1-RA Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Overall Study Incomplete data	4	3
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	2	0

Baseline Characteristics

Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Total n=51 Participants Total of all reporting groups
Age, Customized Age	69 years n=5 Participants	72 years n=7 Participants	69 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	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	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	23 Participants n=7 Participants	48 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	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	24 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 120 hours post initiating chemotherapy during cycle 1

Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.

Outcome measures

Outcome measures
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)	11 Participants	14 Participants

SECONDARY outcome

Timeframe: 24 hours post initiating chemotherapy during cycle 1

Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.

Outcome measures

Outcome measures
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)	19 Participants	22 Participants

SECONDARY outcome

Timeframe: 24-120 hours post initiating chemotherapy during cycle 1

Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.

Outcome measures

Outcome measures
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)	14 Participants	14 Participants

SECONDARY outcome

Timeframe: 24 hours post initiating chemotherapy during cycle 1

Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).

Outcome measures

Outcome measures
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)	17 Participants	19 Participants

SECONDARY outcome

Timeframe: 120 hours post initiating chemotherapy during cycle 1

Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).

Outcome measures

Outcome measures
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)	10 Participants	8 Participants

SECONDARY outcome

Timeframe: 120 hours post initiating chemotherapy during cycle 1

Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).

Outcome measures

Outcome measures
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)	9 Participants	6 Participants

SECONDARY outcome

Timeframe: assessed daily, and reported at day 6 post final study treatment

Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).

Outcome measures

Outcome measures
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Mean Somnolence Score	0.81 score on a scale Interval 0.13 to 1.49	1.15 score on a scale Interval 0.39 to 1.93

SECONDARY outcome

Timeframe: assessed daily, and reported at day 6 post final study treatment

Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).

Outcome measures

Outcome measures
Measure	Nk1-RA n=27 Participants Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 Participants Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Mean Increased-appetite Score	0.45 score on a scale Interval 0.06 to 0.85	0.33 score on a scale Interval 0.09 to 0.56

Adverse Events

Nk1-RA

Serious events: 3 serious events

Other events: 24 other events

Deaths: 4 deaths

Olanzapine

Serious events: 5 serious events

Other events: 23 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Nk1-RA n=27 participants at risk Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5	Olanzapine n=24 participants at risk Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Gastrointestinal disorders Abdominal pain	0.00% 0/27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	4.2% 1/24 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Investigations anemia	3.7% 1/27 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	0.00% 0/24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Nervous system disorders syncope	3.7% 1/27 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	0.00% 0/24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
General disorders fall	3.7% 1/27 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	0.00% 0/24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
General disorders dizziness	3.7% 1/27 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	0.00% 0/24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Investigations hyponatremia	3.7% 1/27 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	0.00% 0/24 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Investigations creatinine increased	0.00% 0/27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	4.2% 1/24 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Gastrointestinal disorders vomiting	0.00% 0/27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	8.3% 2/24 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Gastrointestinal disorders nausea	0.00% 0/27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	4.2% 1/24 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Gastrointestinal disorders dysphagia	0.00% 0/27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	4.2% 1/24 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Respiratory, thoracic and mediastinal disorders dyspnea	0.00% 0/27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	4.2% 1/24 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
General disorders debulking surgery	0.00% 0/27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints	4.2% 1/24 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints

Other adverse events

Additional Information

University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin

University of Michigan Rogel Cancer Center

Phone: 734-936-9499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place