Trial Outcomes & Findings for Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Previously Been Treated With Immunotherapy (NCT NCT03965689)
NCT ID: NCT03965689
Last Updated: 2025-09-22
Results Overview
Response will be evaluated at the time all participants completed treatment and using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Patients will be re-evaluated for response every 6 weeks. Overall response is the best response achieved during the study. Complete response (CR) is the disappearance of all lesions; Partial response (PR) is a \>= 30% decrease in the sum of the target lesions; Progressive disease (PD) is a \>= 20% increase in the sum of the lesions; Stable disease (SD) is between a 20 % increase and 30% decrease in the sum of the lesions.
ACTIVE_NOT_RECRUITING
PHASE2
27 participants
Up to 2.5 years
2025-09-22
Participant Flow
Participant milestones
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Too sick to get study intervention
|
2
|
Baseline Characteristics
Testing the Combination of MLN4924 (Pevonedistat), Carboplatin, and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Previously Been Treated With Immunotherapy
Baseline characteristics by cohort
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
n=27 Participants
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
|
Height
|
166.5 centimeter (cm)
n=5 Participants
|
|
Weight
|
71.8 kilogram (kg)
n=5 Participants
|
|
Body Surface Area (BSA)
|
1.81 meters squared (m^2)
n=5 Participants
|
|
Disease Stage
Advanced Disease (Stage IIIB)
|
2 Participants
n=5 Participants
|
|
Disease Stage
Metastatic Disease (Stage IV)
|
25 Participants
n=5 Participants
|
|
Smoking Status
Current Smoker
|
3 Participants
n=5 Participants
|
|
Smoking Status
Former Smoker
|
19 Participants
n=5 Participants
|
|
Smoking Status
Never Smoked
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2.5 yearsResponse will be evaluated at the time all participants completed treatment and using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. Patients will be re-evaluated for response every 6 weeks. Overall response is the best response achieved during the study. Complete response (CR) is the disappearance of all lesions; Partial response (PR) is a \>= 30% decrease in the sum of the target lesions; Progressive disease (PD) is a \>= 20% increase in the sum of the lesions; Stable disease (SD) is between a 20 % increase and 30% decrease in the sum of the lesions.
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
n=25 Participants
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With an Overall Response
Complete Response (CR)
|
0 Participants
|
|
Number of Participants With an Overall Response
Partial Response (PR)
|
4 Participants
|
|
Number of Participants With an Overall Response
Stable Disease (SD)
|
15 Participants
|
|
Number of Participants With an Overall Response
Progressive Disease (PD)
|
4 Participants
|
|
Number of Participants With an Overall Response
Not Assessed (NA)
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsProgression free survival (PFS) is defined at the time all participants completed treatment and using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as \>= 20% increase in the sum of target lesions, a measurable increase in a non-target lesion, or the appearance of a new lesion. The duration is measured from the start of treatment to the time of progression or death, whichever occurs first.
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
n=25 Participants
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Progression Free Survival (PFS)
|
3.68 months
Interval 0.46 to 19.67
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsDefined as the duration of time from start of treatment to time of death or last known date alive at the time all participants completed treatment.
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
n=25 Participants
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival (OS)
|
7.73 months
Interval 0.79 to 21.71
|
SECONDARY outcome
Timeframe: 1 year, on averageEvaluated by the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
n=25 Participants
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants Reporting Grade 3, 4, and 5 Adverse Events
Grades 3, 4, and 5
|
21 Participants
|
|
Number of Participants Reporting Grade 3, 4, and 5 Adverse Events
Grades 1 and 2
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 pre-treatment and 6 hours post-infusionSummarized using descriptive statistics. Ratios of the day 1 pre-treatment over the 6 hours post-infusion levels will be calculated and reported along with the corresponding 95% confidence intervals. A one sample t-test or Wilcoxon Signed Rank test will be used to evaluate changes from the day 1 pre-treatment to the 6 hours post-infusion assessment. A two-sample t-test or nonparametric Wilcoxon Rank Sum test will be used to compared changes in NQO1 expression levels from day 1 pre-treatment to 6 hours post-infusion between responders and non-responders.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 pre-treatment and 6 hours post-infusionSummarized using descriptive statistics. Ratios of the day 1 pre-treatment over the 6 hours post-infusion levels will be calculated and reported along with the corresponding 95% confidence intervals. A one sample t-test or Wilcoxon Signed Rank test will be used to evaluate changes from the day 1 pre-treatment to the 6 hours post-infusion assessment. A two-sample t-test or nonparametric Wilcoxon Rank Sum test will be used to compared changes in SLC7A11 expression levels from day 1 pre-treatment to 6 hours post-infusion between responders and non-responders.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Qualitative assessment of tumor NAE1 expression will be conducted by evaluating descriptive summaries of NAE1 expression levels. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Qualitative assessment of tumor UBC12 expression will be conducted by evaluating descriptive summaries of UBC12 expression levels. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and after treatment with pevonedistatA linear mixed effects model with patient -specific random effects will be utilized to compared changes in RAD51. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and after treatment with pevonedistatA linear mixed effects model with patient -specific random effects will be utilized to compared changes in gammaH2AX. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, and ranges, stratified by assessment time point. Changes from the pre-treatment to post-infusion assessment will be evaluated using a paired t-test or nonparametric Wilcoxon Signed Rank test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-treatment and 6 hours post-infusion on cycle 1, day 1Summarized in terms of means, standard deviations, medians, and ranges, stratified by assessment time point. Changes in PK parameters between assessment time points will be evaluated using a paired t-test.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
Serious adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
n=25 participants at risk
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Diverticultis
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
General disorders
Death NOS
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
General disorders
Fever
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
General disorders
Polytrauma related to motor vehicle accident
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
General disorders
Non-cardiac chest pain
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Infections and infestations
COVID-19 Infection
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Infections and infestations
Sepsis
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Nervous system disorders
Ataxia
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Vascular disorders
Thromboembolic event
|
4.0%
1/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
Other adverse events
| Measure |
Treatment (Paclitaxel, Carboplatin, Pevonedistat)
n=25 participants at risk
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
15/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Cardiac disorders
Sinus bradycardia
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Cardiac disorders
Tachycardia
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Constipation
|
32.0%
8/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Diarrhea
|
16.0%
4/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Nausea
|
44.0%
11/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
General disorders
Edema limbs
|
12.0%
3/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
General disorders
Fatigue
|
44.0%
11/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
General disorders
Flu like symptoms
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
General disorders
Pain
|
24.0%
6/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Infections and infestations
Papulopustular rash
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Infections and infestations
Transaminitis
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
15/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
Alkaline phosphatase increased
|
32.0%
8/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
15/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
Creatinine increased
|
16.0%
4/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
5/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
Neutrophil count decreased
|
56.0%
14/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
Platelet count decreased
|
48.0%
12/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Investigations
White blood cell decreased
|
52.0%
13/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.0%
6/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.0%
4/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
5/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
5/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
28.0%
7/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.0%
4/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
5/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
28.0%
7/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
4/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.0%
3/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
5/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Nervous system disorders
Dizziness
|
20.0%
5/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Nervous system disorders
Paresthesia
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.0%
4/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Psychiatric disorders
Anxiety
|
12.0%
3/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Psychiatric disorders
Confusion
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Psychiatric disorders
Insomnia
|
20.0%
5/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.0%
4/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.0%
12/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
5/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.0%
4/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Vascular disorders
Hypertension
|
12.0%
3/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
|
Vascular disorders
Hypotension
|
8.0%
2/25 • From initiation of study therapy to completion of adverse event (AE) observation period. The longest duration for all participants was about 1.75 years.
|
Additional Information
Grants Administrative Manager
Johns Hopkins University/SKCCC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60