Trial Outcomes & Findings for Single Arm on the Tolerability of Weekly Nab-paclitaxel (NCT NCT01702844)
NCT ID: NCT01702844
Last Updated: 2020-10-08
Results Overview
Tolerability of weekly nab-paclitaxel, as measured by occurrence of Grade 3 or worse toxicity after 6 cycles or 3 weeks after discontinuation of treatment, for those who came off treatment earlier as measured by the NCI Common Terminology Criteria for Adverse Events CTCAE, version 4. The CTCAE is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)
Results posted on
2020-10-08
Participant Flow
A total of 42 participants were accrued between June 2013 and April 2017 at 7 institutions in the United States
Another 9 participants signed consent but did not start the trial due to screen failure (6), progression of disease prior to study start (1) and withdrawal of consent prior to start (2.)
Participant milestones
| Measure |
Nab Paclitaxel
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
Disease Progression
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Nab Paclitaxel
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
6
|
Baseline Characteristics
Single Arm on the Tolerability of Weekly Nab-paclitaxel
Baseline characteristics by cohort
| Measure |
Nab Paclitaxel
n=42 Participants
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Age, Continuous
|
76.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
|
Smoking status
Never smoker
|
4 Participants
n=5 Participants
|
|
Smoking status
Former/current smoker
|
38 Participants
n=5 Participants
|
|
Performance status
0, Fully active
|
5 Participants
n=5 Participants
|
|
Performance status
1, Restricted in strenuous activity but ambulatory
|
28 Participants
n=5 Participants
|
|
Performance status
2, limited selfcare
|
9 Participants
n=5 Participants
|
|
Exercise
Never
|
10 Participants
n=5 Participants
|
|
Exercise
Few times per month
|
3 Participants
n=5 Participants
|
|
Exercise
1-2 times per week
|
6 Participants
n=5 Participants
|
|
Exercise
3-4 times per week
|
2 Participants
n=5 Participants
|
|
Exercise
More than or equal to 5 times per week
|
1 Participants
n=5 Participants
|
|
Exercise
Unknown/Not reported
|
20 Participants
n=5 Participants
|
|
Alcohol
No
|
13 Participants
n=5 Participants
|
|
Alcohol
Yes
|
7 Participants
n=5 Participants
|
|
Alcohol
Almost never
|
7 Participants
n=5 Participants
|
|
Alcohol
Unknown/Not reported
|
15 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
35 Participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
7 Participants
n=5 Participants
|
|
Prior treatment regimens
Carboplatin plus pemetrexed
|
26 Participants
n=5 Participants
|
|
Prior treatment regimens
Carboplatin, pemetrexed, and bevacizumab
|
4 Participants
n=5 Participants
|
|
Prior treatment regimens
Cisplatin plus pemetrexed
|
1 Participants
n=5 Participants
|
|
Prior treatment regimens
Carboplatin plus gemcitabine
|
11 Participants
n=5 Participants
|
|
Prior treatment regimens
Nivolumab
|
8 Participants
n=5 Participants
|
|
Prior treatment regimens
Erlotinib
|
1 Participants
n=5 Participants
|
|
Prior treatment regimens
Other prior regimens
|
3 Participants
n=5 Participants
|
|
Best response to prior therapies
Complete response
|
0 Participants
n=5 Participants
|
|
Best response to prior therapies
Partial response
|
3 Participants
n=5 Participants
|
|
Best response to prior therapies
Stable disease
|
16 Participants
n=5 Participants
|
|
Best response to prior therapies
Progressive disease
|
22 Participants
n=5 Participants
|
|
Best response to prior therapies
Unknown/Not evaluable
|
13 Participants
n=5 Participants
|
|
Frailty index
Robust (0 to <0.2)
|
5 Participants
n=5 Participants
|
|
Frailty index
Prefrail (0.2-0.35)
|
10 Participants
n=5 Participants
|
|
Frailty index
Frail (>0.35)
|
11 Participants
n=5 Participants
|
|
Frailty index
Unknown/Not assessed
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)Tolerability of weekly nab-paclitaxel, as measured by occurrence of Grade 3 or worse toxicity after 6 cycles or 3 weeks after discontinuation of treatment, for those who came off treatment earlier as measured by the NCI Common Terminology Criteria for Adverse Events CTCAE, version 4. The CTCAE is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
Nab Paclitaxel
n=42 Participants
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Number of Subjects Without Any Adverse Events Grade 3 or Higher
|
28 Participants
|
SECONDARY outcome
Timeframe: up to 2 years after end of treatment (treatment lasts up to 168 days (up to 6 cycles of 28 days each))Overall Survival is defined as the time from day 1 (D1) of treatment until death as a result of any cause
Outcome measures
| Measure |
Nab Paclitaxel
n=42 Participants
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Median Overall Survival
|
9.3 Months
Interval 6.4 to 12.1
|
SECONDARY outcome
Timeframe: up to 2 years after end of treatment (treatment lasts up to 168 days (up to 6 cycles of 28 days each))Progression free survival is defined as the time from D1 of treatment until progression or death as a result of any cause. Progressive Disease (PD) is determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. PD is at least a 20% increase in the sum of the longest diameters (LD) of the target lesions taking as reference the smallest sum LD recorded since the treatment started including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters. The appearance of one or more new lesions also constitutes PD.
Outcome measures
| Measure |
Nab Paclitaxel
n=42 Participants
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Median Progression Free Survival
|
5.2 Months
Interval 2.0 to 7.4
|
SECONDARY outcome
Timeframe: 168 days after start of treatment (6 cycles) (or 3 weeks after discontinuation of treatment, for those who come off treatment earlier)Population: 4 subjects were not analyzed for this outcome due to lack of follow up disease assessments (off treatment after only one cycle for hospice and/or death)
Response will be measured by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) version 1.1, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. The Overall Response rate is defined as the percentage of participants with CR or PR
Outcome measures
| Measure |
Nab Paclitaxel
n=38 Participants
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Overall Response Rate
|
34.2 percentage of patients with response
Interval 19.6 to 51.4
|
Adverse Events
Nab Paclitaxel
Serious events: 15 serious events
Other events: 41 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Nab Paclitaxel
n=42 participants at risk
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Cardiac disorders
Atrioventricular block complete
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Bronchial infection
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Chills
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Fever
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Gait disturbance
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Cardiac disorders
Heart failure
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Cardiac disorders
Pericardial effusion
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Stroke
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Vascular disorders
Vasculitis
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
White blood cell decreased
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
Other adverse events
| Measure |
Nab Paclitaxel
n=42 participants at risk
Patients will receive nab-paclitaxel once weekly for 3 weeks of every 4 week cycle
Nab-Paclitaxel: Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.9%
5/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Alanine aminotransferase i
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Alkaline phosphatase incre
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
12/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Anal hemorrhage
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
18/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
8/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Aspartate aminotransferase
|
9.5%
4/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Blood and lymphatic system disorders
Blood and lymphatic system
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Blood bilirubin increased
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Eye disorders
Blurred vision
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Bronchial infection
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Cardiac disorders
Cardiac disorders - Other,
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Constipation
|
26.2%
11/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
6/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Creatinine increased
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Psychiatric disorders
Depression
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Diarrhea
|
19.0%
8/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Dysarthria
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Dysgeusia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.0%
8/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Edema limbs
|
38.1%
16/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Endocrine disorders
Endocrine disorders - Othe
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Eye disorders
Eye disorders - Other, spe
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Fatigue
|
61.9%
26/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Fever
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
General disorders and admi
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weaknes
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Reproductive system and breast disorders
Genital edema
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Headache
|
11.9%
5/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Vascular disorders
Hot flashes
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.0%
8/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Vascular disorders
Hypertension
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
7/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
19.0%
8/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
3/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Vascular disorders
Hypotension
|
11.9%
5/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Infusion site extravasatio
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Psychiatric disorders
Insomnia
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Lymphocyte count decreased
|
19.0%
8/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Metabolism and nutrition disorders
Metabolism and nutrition d
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Mucosal infection
|
11.9%
5/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Mucositis oral
|
9.5%
4/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.9%
5/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Nail infection
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Nausea
|
28.6%
12/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Neutrophil count decreased
|
35.7%
15/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
General disorders
Pain
|
9.5%
4/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.5%
4/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Paresthesia
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Paronychia
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Peripheral motor neuropath
|
9.5%
4/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Peripheral sensory neuropa
|
47.6%
20/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Platelet count decreased
|
9.5%
4/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Presyncope
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.9%
5/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Renal and urinary disorders
Renal and urinary disorder
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Eye disorders
Retinal vascular disorder
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Sinusitis
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Skin infection
|
9.5%
4/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Cardiac disorders
Supraventricular tachycard
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Syncope
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Vascular disorders
Thromboembolic event
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Transient ischemic attacks
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Upper respiratory infectio
|
14.3%
6/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Renal and urinary disorders
Urinary frequency
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Vascular disorders
Vasculitis
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
7/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Eye disorders
Watering eyes
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Weight gain
|
2.4%
1/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
Weight loss
|
4.8%
2/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
|
Investigations
White blood cell decreased
|
38.1%
16/42 • From day 1 of study treatment to 30 days after treatment is discontinued (with an average treatment duration of 168 days)
|
Additional Information
Robin V. Johnson
University of North Carolina Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place