Trial Outcomes & Findings for PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer (NCT NCT02837263)
NCT ID: NCT02837263
Last Updated: 2026-05-01
Results Overview
Determine the recurrence rate at 1 year following clearance of metastatic disease in the setting of treatment with SBRT and pembrolizumab
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
1 year
Results posted on
2026-05-01
Participant Flow
Participants were enrolled at UW Health from August 2016 to March 2020.
Participant milestones
| Measure |
SBRT + Pembrolizumab
Participants receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment, then will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery participants will begin the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab participants will also have tumor imaging (CT or MRI).
Stereotactic body radiotherapy (SBRT): SBRT treatment will consist of 40-60 Gy delivered in five fractions prescribed to the planning target volume (PVT). Image guidance with MRI, megavoltage CT or cone beam CT scans would be required.
SBRT will be initiated on Day 0. This should be initiated within 4 weeks of signing informed consent. An additional 2 weeks will be allowed if necessary due to SBRT treatment planning.
Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. KeytrudaTM (pembrolizumab) has recently been approved in the United Stated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipiliumumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
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Overall Study
STARTED
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15
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Overall Study
Analysis Population
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15
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Overall Study
Followed Greater Than 1 Year Post Resection
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14
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
SBRT + Pembrolizumab
n=15 Participants
Participants receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment, then will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery participants will begin the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab participants will also have tumor imaging (CT or MRI).
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Age, Continuous
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64 years
n=14 Participants
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Sex: Female, Male
Female
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4 Participants
n=14 Participants
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Sex: Female, Male
Male
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11 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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15 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=14 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=14 Participants
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Race (NIH/OMB)
White
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15 Participants
n=14 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=14 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=14 Participants
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Region of Enrollment
United States
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15 participants
n=14 Participants
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Primary Tumor Location
Colon
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10 Participants
n=14 Participants
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Primary Tumor Location
Rectum
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5 Participants
n=14 Participants
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Stage at Diagnosis
Stage I
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0 Participants
n=14 Participants
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Stage at Diagnosis
Stage II
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1 Participants
n=14 Participants
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Stage at Diagnosis
Stage III
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7 Participants
n=14 Participants
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Stage at Diagnosis
Stage IV
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7 Participants
n=14 Participants
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Prior Chemotherapy
History of mFOLFOX treatment
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6 Participants
n=14 Participants
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Prior Chemotherapy
Neoadjuvant mFOLFOX immediately prior
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9 Participants
n=14 Participants
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Number of Liver Lesions
1
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10 Participants
n=14 Participants
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Number of Liver Lesions
2-5
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1 Participants
n=14 Participants
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Number of Liver Lesions
greater than 5
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4 Participants
n=14 Participants
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Primary Tumor Resected Prior to Enrollment
Yes
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12 Participants
n=14 Participants
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Primary Tumor Resected Prior to Enrollment
No
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3 Participants
n=14 Participants
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Mutation Profile
KRAS MT
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5 Participants
n=14 Participants
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Mutation Profile
NRAS MT
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0 Participants
n=14 Participants
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Mutation Profile
BRAF V600 MT
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3 Participants
n=14 Participants
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Mutation Profile
KRAS/NRAS/BRAF V600 WT
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7 Participants
n=14 Participants
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Mismatch Repair Status
Proficient
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15 Participants
n=14 Participants
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Mismatch Repair Status
Deficient
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0 Participants
n=14 Participants
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PRIMARY outcome
Timeframe: 1 yearDetermine the recurrence rate at 1 year following clearance of metastatic disease in the setting of treatment with SBRT and pembrolizumab
Outcome measures
| Measure |
SBRT + Pembrolizumab
n=15 Participants
Participants receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment, then will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery participants will begin the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab participants will also have tumor imaging (CT or MRI).
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Recurrence Rate at 1 Year
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6 Participants
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SECONDARY outcome
Timeframe: up to 6 yearsThe 95% confidence of the median time to recurrence will be calculated using the Brookmeyer-Crowley method
Outcome measures
| Measure |
SBRT + Pembrolizumab
n=15 Participants
Participants receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment, then will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery participants will begin the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab participants will also have tumor imaging (CT or MRI).
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Time to Recurrence Estimated Using the Kaplan-Meier Method
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295 days
Interval 266.0 to 321.0
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SECONDARY outcome
Timeframe: up to 6 yearsThe 95% confidence of the median time to disease free survival calculated using the Brookmeyer-Crowley method.
Outcome measures
| Measure |
SBRT + Pembrolizumab
n=15 Participants
Participants receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment, then will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery participants will begin the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab participants will also have tumor imaging (CT or MRI).
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Disease-free Survival Estimated Using the Kaplan-Meier Method
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1.17 years
Interval 0.56 to 2.5
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SECONDARY outcome
Timeframe: up to 6 yearsThe 95% confidence of the median time to overall survival calculated using the Brookmeyer-Crowley method.
Outcome measures
| Measure |
SBRT + Pembrolizumab
n=15 Participants
Participants receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment, then will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery participants will begin the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab participants will also have tumor imaging (CT or MRI).
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Overall Survival Estimated Using the Kaplan-Meier Method
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NA years
Insufficient number of participants with events
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OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearImaging biomarkers (SUVtot, SUVmean, SUVmax) will be summarized using standard descriptive statistics in terms of means, standard deviations, medians, and ranges. Percentage changes in imaging biomarkers will be calculated between assessment time points. Logistic regression analysis will be conducted to evaluate whether changes in imaging biomarkers predict the recurrence rate at 1 year following clearance of metastatic disease.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearThe number of tumor-infiltrating lymphocytes will be summarized in terms of means and standard deviations for each assessment time point. A negative binomial regression or overdispersed Poisson regression model with patient specific random effects will be used to evaluate changes in the number of tumor-infiltrating lymphocytes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearLinear regression analysis will be conducted to examine the correlation between expression levels of PDL1 in colorectal cancer (CRC) liver metastases.
Outcome measures
Outcome data not reported
Adverse Events
SBRT + Pembrolizumab
Serious events: 4 serious events
Other events: 15 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
SBRT + Pembrolizumab
n=15 participants at risk
Participants receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment, then will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery participants will begin the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab participants will also have tumor imaging (CT or MRI).
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Gastrointestinal disorders
Ileus
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6.7%
1/15 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
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13.3%
2/15 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Blood bilirubin increased
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6.7%
1/15 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Other adverse events
| Measure |
SBRT + Pembrolizumab
n=15 participants at risk
Participants receive stereotactic body radiotherapy (SBRT) within 4 weeks of enrollment, then will receive one cycle of pre-operative pembrolizumab given as an IV over approximately 30 minutes. Surgical management to remove all known sites of metastatic disease should occur 2 weeks post pembrolizumab treatment. Approximately 4-8 weeks after surgery participants will begin the second phase of pembrolizumab treatment. They will receive this treatment every 3 weeks (cycle) for 8 more cycles after surgery. Prior to the 5th cycle of pembrolizumab participants will also have tumor imaging (CT or MRI).
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Investigations
Lymphocyte count decreased
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66.7%
10/15 • Number of events 28 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Aspartate aminotransferase increased
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60.0%
9/15 • Number of events 14 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Platelet count decreased
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46.7%
7/15 • Number of events 15 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
White blood cell decreased
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33.3%
5/15 • Number of events 11 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Alanine aminotransferase increased
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26.7%
4/15 • Number of events 8 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Alkaline phosphatase increased
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26.7%
4/15 • Number of events 5 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Creatinine increased
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26.7%
4/15 • Number of events 4 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Blood bilirubin increased
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13.3%
2/15 • Number of events 6 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Weight loss
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13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Neutrophil count decreased
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6.7%
1/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Investigations
Weight gain
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6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hypoalbuminemia
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60.0%
9/15 • Number of events 10 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hypokalemia
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33.3%
5/15 • Number of events 8 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hypophosphatemia
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33.3%
5/15 • Number of events 7 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hyponatremia
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26.7%
4/15 • Number of events 6 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hyperuricemia
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20.0%
3/15 • Number of events 4 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Anorexia
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13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hypomagnesemia
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hyperglycemia
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6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hypernatremia
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6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
1/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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Gastrointestinal disorders
Abdominal pain
|
40.0%
6/15 • Number of events 9 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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|
Gastrointestinal disorders
Nausea
|
40.0%
6/15 • Number of events 10 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
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|
Gastrointestinal disorders
Diarrhea
|
26.7%
4/15 • Number of events 9 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Number of events 3 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Gastrointestinal disorders
Dry mouth
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Gastrointestinal disorders
Anal pain
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Gastrointestinal disorders
Ileus
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
General disorders
Fatigue
|
40.0%
6/15 • Number of events 8 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
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General disorders
Edema limbs
|
13.3%
2/15 • Number of events 3 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
General disorders
Facial pain
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
9/15 • Number of events 17 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Vascular disorders
Hypertension
|
53.3%
8/15 • Number of events 15 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Vascular disorders
Hot flashes
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
3/15 • Number of events 3 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Infections and infestations
Urinary tract infection
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Infections and infestations
Wound infection
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Infections and infestations
Eye infection
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Nervous system disorders
Dizziness
|
20.0%
3/15 • Number of events 3 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.3%
2/15 • Number of events 2 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Endocrine disorders
Hyperthyroidism
|
20.0%
3/15 • Number of events 3 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • Number of events 3 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Cardiac disorders
Atrial flutter
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Eye disorders
Cataract
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Eye disorders
Eye pain
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Hepatobiliary disorders
Hepatic pain
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Number of events 1 • Adverse Events will be recorded from the time of consent through 30 days following cessation of treatment and at each examination on the Adverse Event case report forms or worksheets. Serious Adverse Events (SAEs) will be recorded from consent through 90 days following cessation of treatment, or the initiation of new anti-cancer therapy, whichever is earlier. All AE data collected up to approximately 1 year on study. All-cause mortality data was collected for up to approximately 6 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place