Trial Outcomes & Findings for Trial of Pevonedistat Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NCT NCT03228186)

Last Updated: 2023-10-23

Results Overview

Response is defined as either Partial Response or Complete Response. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. Complete Response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Up to 2 Years

Results posted on

2023-10-23

Participant Flow

9 patients screen failed

Participant milestones

Participant milestones
Measure	Pevonedistat Plus Docetaxel Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pevonedistat Plus Docetaxel Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
Overall Study Patient never started treatment	1

Baseline Characteristics

Trial of Pevonedistat Plus Docetaxel in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pevonedistat Plus Docetaxel n=40 Participants Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=93 Participants
Age, Categorical >=65 years	17 Participants n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	21 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	34 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	40 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 2 Years

Population: 27 patients participated in the trial long enough to be considered evaluable for this outcome measure

Outcome measures

Outcome measures
Measure	Pevonedistat Plus Docetaxel n=27 Participants Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
The Percentage of Patients That Respond to Treatment	22 percent of participants Interval 11.0 to 37.0

SECONDARY outcome

Timeframe: Up to 2 Years

Progression-free survival is defined as the duration of time from start of treatment to time of progression. Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Pevonedistat Plus Docetaxel n=27 Participants Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
Median Progression Free Survival Time	124 days Interval 88.0 to 209.0

SECONDARY outcome

Timeframe: Up to 2 Years

Overall survival is defined as the duration of time from start of treatment to time of passing.

Outcome measures

Outcome measures
Measure	Pevonedistat Plus Docetaxel n=27 Participants Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
Median Overall Survival Time	397 days Interval 223.0 to The confidence interval for the median is calculated based on the confidence limits for the estimated survival function. If the upper limit does not cross the horizontal line at 0.5, then the upper confidence limit for the median does not exist.

SECONDARY outcome

Timeframe: Up to 2 Years

Stable disease rate will be reported as the count and proportion of patients who achieve stable disease. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum LD since the treatment started.

Outcome measures

Outcome measures
Measure	Pevonedistat Plus Docetaxel n=27 Participants Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
The Number of Patients Who Achieve Stable Disease	12 Participants

SECONDARY outcome

Timeframe: up to 30 days post last study drug dose, patients were allowed to stay on study drug treatment until progression. Data was collected over 3.5 years.

Population: Percentage of Grade 3-5 Adverse Events classified according to the Row Titles. The investigations group represents adverse events due to treatment drugs.

All recorded toxicities will be listed and tabulated by system organ class. The NCI CTCAE version 4.03 will be utilized for AE reporting.

Outcome measures

Outcome measures
Measure	Pevonedistat Plus Docetaxel n=90 adverse events Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
The Number of Toxicities by System Organ Class General disorders and administration site conditions- grade 3	10 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class hepatobiliary disorders- grade 3	3.3 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class infections and infestations- grade 3	3.3 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class infections and infestations- grade 4	3.3 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class Blood and Lymphatic system disorders- grade 3	10 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class Gastrointestinal disorders- grade 3	6.7 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class investigations- grade 3	16.7 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class investigations- grade 4	13.3 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class metabolism and nutrition disorders- grade 3	3.3 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class nervous system disorders- grade 3	3.3 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class respiratory, thoracic and mediastinal disorders- grade 3	3.3 percentage of Grade 3-5 Adverse Events
The Number of Toxicities by System Organ Class Skin and subcutaneous tissue disorders- grade 3	3.3 percentage of Grade 3-5 Adverse Events

Adverse Events

Pevonedistat Plus Docetaxel

Serious events: 12 serious events

Other events: 30 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Pevonedistat Plus Docetaxel n=30 participants at risk Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
Musculoskeletal and connective tissue disorders Buttock Pain	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Dysphagia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Enterocolitis infection	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders fatigue	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Blood and lymphatic system disorders Febrile neutropenia	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Blood and lymphatic system disorders Hepatobiliary Disorders- other	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Hypoxia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Lung infections	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Neutrophil count decreased	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Non-cardiac chest pain	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Sepsis	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Stroke	3.3% 1/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Urinary Tract Infection	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows

Other adverse events

Other adverse events
Measure	Pevonedistat Plus Docetaxel n=30 participants at risk Pevonedistat 25mg/m2 days 1, 3, 5 Docetaxel 75mg/m2 day 1 21 day cycle Pevonedistat: 25mg/m2 days 1, 3, 5 Docetaxel: 75mg/m2 day 1
General disorders Abdominal pain	10.0% 3/30 • Number of events 4 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Alanine aminotransferase increased	43.3% 13/30 • Number of events 24 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Alkaline phosphatase increased	13.3% 4/30 • Number of events 5 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Alopecia	26.7% 8/30 • Number of events 8 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Anemia	16.7% 5/30 • Number of events 5 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Metabolism and nutrition disorders Anorexia	13.3% 4/30 • Number of events 4 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Psychiatric disorders Anxiety	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Musculoskeletal and connective tissue disorders Arthritis	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Aspartate aminotransferase increased	50.0% 15/30 • Number of events 23 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Back pain	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Bloating	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Blood bilirubin increased	10.0% 3/30 • Number of events 4 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Musculoskeletal and connective tissue disorders Bone pain	10.0% 3/30 • Number of events 3 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Cardiac disorders Chest pain - cardiac	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Chills	6.7% 2/30 • Number of events 3 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Psychiatric disorders Confusion	10.0% 3/30 • Number of events 4 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Conjunctivitis	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Constipation	10.0% 3/30 • Number of events 4 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Cough	13.3% 4/30 • Number of events 6 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Creatinine increased	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Metabolism and nutrition disorders Dehydration	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Diarrhea	20.0% 6/30 • Number of events 6 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Dizziness	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Dry skin	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Dysgeusia	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Dysphagia	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Dysphasia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Dyspnea	16.7% 5/30 • Number of events 5 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Edema limbs	13.3% 4/30 • Number of events 4 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Reproductive system and breast disorders Erectile dysfunction	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Ear and labyrinth disorders External ear pain	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Eye disorders Eye disorders - Other, specify	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Eye disorders Eye pain	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Injury, poisoning and procedural complications Fall	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Fatigue	73.3% 22/30 • Number of events 28 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Fever	10.0% 3/30 • Number of events 3 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Gastroesophageal reflux disease	10.0% 3/30 • Number of events 3 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Headache	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Ear and labyrinth disorders Hearing impaired	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Hematuria	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Hyperglycemia	16.7% 5/30 • Number of events 5 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Hyperkalemia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Cardiac disorders Hypertension	6.7% 2/30 • Number of events 3 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Hypocalcemia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Hypophosphatemia	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Hypoxia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Infections and infestations - Other,	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Infusion related reaction	6.7% 2/30 • Number of events 3 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Psychiatric disorders Insomnia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Lung infection	10.0% 3/30 • Number of events 3 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Lymphocyte count decreased	10.0% 3/30 • Number of events 5 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Mucositis oral	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Musculoskeletal and connective tissue disorders Myalgia	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Nail infection	3.3% 1/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Nail loss	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Nail ridging	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Nausea	36.7% 11/30 • Number of events 13 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Neutrophil count decreased	23.3% 7/30 • Number of events 9 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Non-cardiac chest pain	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Oral pain	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Pain	16.7% 5/30 • Number of events 5 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
General disorders Pain in extremity	16.7% 5/30 • Number of events 6 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Papulopustular rash	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Paresthesia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Paronychia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Peripheral motor neuropathy	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Peripheral sensory neuropathy	33.3% 10/30 • Number of events 17 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations Platelet count decreased	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Pruritus	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Rash acneiform	16.7% 5/30 • Number of events 5 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Rash maculo-papular	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Salivary duct inflammation	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Nervous system disorders Sinus pain	6.7% 2/30 • Number of events 2 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Cardiac disorders Sinus tachycardia	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Sore throat	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Vascular disorders Thromboembolic event	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Renal and urinary disorders Urinary frequency	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Infections and infestations Urinary tract infection	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Respiratory, thoracic and mediastinal disorders Voice alteration	3.3% 1/30 • Number of events 1 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Gastrointestinal disorders Vomiting	13.3% 4/30 • Number of events 5 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Eye disorders Watering eyes	13.3% 4/30 • Number of events 4 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Metabolism and nutrition disorders Weight loss	13.3% 4/30 • Number of events 4 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows
Investigations White blood cell decreased	10.0% 3/30 • Number of events 3 • Up to 30 days post treatment for Serious Adverse Events and Other (Not Including Serious) Adverse Events. Data for serious and non serious adverse events was collected over 3.5 years., All-Cause Mortality was assessed for up to 3.5 years No patients died while within the Adverse Event Reporting windows

Additional Information

Gregory Kalemkerian, MD

Rogel Cancer Center

Phone: 734-647-8921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place