Trial Outcomes & Findings for NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer (NCT NCT04539808)
NCT ID: NCT04539808
Last Updated: 2026-01-14
Results Overview
Using the surgery analysis set, the proportion of resectable or BRPC participants with R0 resection will be estimated with exact 95% CI.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Up to time of surgery
Results posted on
2026-01-14
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Switch PDAC
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Overall Study
STARTED
|
42
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Overall Study
COMPLETED
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42
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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
NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Switch PDAC
n=42 Participants
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Age, Continuous
|
64.8 years
STANDARD_DEVIATION 10.1 • n=9 Participants
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Sex: Female, Male
Female
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19 Participants
n=9 Participants
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Sex: Female, Male
Male
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23 Participants
n=9 Participants
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Race/Ethnicity, Customized
White or Caucasian
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33 Participants
n=9 Participants
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Race/Ethnicity, Customized
Black or African American
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1 Participants
n=9 Participants
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Race/Ethnicity, Customized
Native American-Indigenous or Alaska Native
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3 Participants
n=9 Participants
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Race/Ethnicity, Customized
Asian
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1 Participants
n=9 Participants
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Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
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1 Participants
n=9 Participants
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Race/Ethnicity, Customized
Not Reported/Unknown
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3 Participants
n=9 Participants
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Region of Enrollment
United States
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42 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to time of surgeryPopulation: Per protocol, the surgery safety analysis set is a sub-set of the safety analysis set that includes all participants who undergo surgical resection of their pancreatic cancer
Using the surgery analysis set, the proportion of resectable or BRPC participants with R0 resection will be estimated with exact 95% CI.
Outcome measures
| Measure |
Neoadjuvant Switch PDAC
n=30 Participants
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Proportion of Resectable or BRPC Participants With R0 Resection
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93.33 percentage of participants
Interval 77.9 to 99.2
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SECONDARY outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to the time of tumor progression, or death due to any cause, assessed up to 24 monthsUsing the efficacy analysis set, the estimated distribution of the PFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., gemcitabine/nab-paclitaxel \[GA\] or modified fluorouracil/irinotecan/leucovorin/oxaliplatin \[mFOLFIRINOX\] +/- radiation therapy \[RT\] \[i.e., short- or long-course, or both RT modalities combined\]) will be performed for PFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to the time of tumor progression, or death due to any cause, assessed up to 24 monthsUsing the efficacy analysis set, the estimated distribution of the PFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT \[i.e., short- or long-course, or both RT modalities combined\]) will be performed for PFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of surgery to the time of tumor progression, or death due to any cause, assessed up to 24 monthsUsing the surgery analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. Using the efficacy analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT \[i.e., short- or long-course, or both RT modalities combined\]) will be performed for DFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of surgery to the time of tumor progression, or death due to any cause, assessed up to 24 monthsUsing the efficacy analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT \[i.e., short- or long-course, or both RT modalities combined\]) will be performed for DFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to death due to disease, assessed up to 24 monthsUsing the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. Using the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT \[i.e., short- or long-course, or both RT modalities combined\]) will be performed for OS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to death due to disease, assessed up to 24 monthsUsing the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX\] +/- RT \[i.e., short- or long-course, or both RT modalities combined\]) will be performed for OS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days after surgeryPopulation: Per protocol, the surgery safety analysis set is a sub-set of the safety analysis set that includes all participants who undergo surgical resection of their pancreatic cancer
Using the surgery analysis set, for resectable and BRPC participants, the proportion of participants with peri- and post-operative complications occurring within 30 days is estimated.
Outcome measures
| Measure |
Neoadjuvant Switch PDAC
n=30 Participants
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Proportion of Resectable or BRPC Participants With Peri- and Post-operative Complications [Per the Clavien-Dindo Classification System]
|
97 percentage of participants
Interval 83.0 to 100.0
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SECONDARY outcome
Timeframe: At 30 days post-surgeryPopulation: Per protocol, the surgery safety analysis set is a sub-set of the safety analysis set that includes all participants who undergo surgical resection of their pancreatic cancer
The proportion of resectable or BRPC participants that die within 30 days of surgery
Outcome measures
| Measure |
Neoadjuvant Switch PDAC
n=30 Participants
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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Proportion of Resectable or BRPC Participants That Die Within 30 Days of Surgery
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3.3 percent of participants
Interval 0.1 to 17.2
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SECONDARY outcome
Timeframe: Up to 90 days after last dose of protocol-directed therapyPopulation: Per protocol, the safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
The incidence of grade \>= 3 toxicities per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 will be determined using the safety analysis set. The exact 95% confidence interval will be reported with the point estimate of toxicity rate.
Outcome measures
| Measure |
Neoadjuvant Switch PDAC
n=42 Participants
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Incidence of Grade >= 3 Toxicities
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54.8 percentage of participants
Interval 38.7 to 70.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 24 monthsUsing the safety analysis set, the levels of CA19-9 will be descriptively reported (across all participants).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to time of surgeryPopulation: Per protocol, the surgery safety analysis set is a sub-set of the safety analysis set that includes all participants who undergo surgical resection of their pancreatic cancer
Using the surgery analysis set, the proportion of LAPC participants with R0 resection will be estimated with exact 95% CI.
Outcome measures
| Measure |
Neoadjuvant Switch PDAC
n=1 Participants
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Proportion of LAPC Participants With R0 Resection
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100 percentage of participants
Interval 2.5 to 100.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to time of tumor progression, or death due to any cause (up to 24 months from start of study treatment)Results will be qualitatively described when statistical measures are not feasible.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to time of tumor progression, or death due to any cause (up to 24 months from start of study treatment)Results will be qualitatively described when statistical measures are not feasible.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of surgery to time of tumor progression, or death due to any cause (up to 24 months from start of study treatment)Results will be qualitatively described when statistical measures are not feasible.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of surgery to time of tumor progression, or death due to any cause (up to 24 months from start of study treatment)Results will be qualitatively described when statistical measures are not feasible.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to death due to any cause, assessed up to 24 months from start of study treatmentResults will be qualitatively described when statistical measures are not feasible.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the start of neoadjuvant therapy (day 1) to death due to any cause, assessed up to 24 months from start of study treatmentResults will be qualitatively described when statistical measures are not feasible.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of surgery to within 30 days from date of surgeryPopulation: Per protocol, the surgery safety analysis set is a sub-set of the safety analysis set that includes all participants who undergo surgical resection of their pancreatic cancer
Using the surgery analysis set, for LAPC participants, the proportion of participants with peri- and post-operative complications occurring within 30 days is estimated.
Outcome measures
| Measure |
Neoadjuvant Switch PDAC
n=1 Participants
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Proportion of LAPC Participants With Peri- and Post-operative Complications
|
100 percentage of participants
Interval 2.5 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of surgery to 30 days post-surgeryResults will be qualitatively described when statistical measures are not feasible.
Outcome measures
| Measure |
Neoadjuvant Switch PDAC
n=1 Participants
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Proportion of LAPC Participants Who Die Within 30 Days of Surgery
|
0 Participants
|
Adverse Events
Neoadjuvant Switch PDAC
Serious events: 22 serious events
Other events: 42 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Neoadjuvant Switch PDAC
n=42 participants at risk
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
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|---|---|
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Cardiac disorders
Atrial flutter
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
11.9%
5/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Biliary tract infection
|
4.8%
2/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Appendicitis
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Sepsis
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Hepatic infection
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
Other adverse events
| Measure |
Neoadjuvant Switch PDAC
n=42 participants at risk
Experimental: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycles. Those with response and no disease progression may receive an additional 2 months.
GA REGIMEN: Those with disease progression or toxicity to mFOLFIRINOX switch to GA regimen comprising gemcitabine hydrochloride IV over 30-60 mins and nab-paclitaxel IV over 30-40 mins on days 1, 8, and 15. Repeats every 28 days for 2 cycles.
LOSARTAN: Cycle 1 day 1, start losartan potassium orally once daily until end of RT.
RT/SURGERY: Short-course RT for 10 fractions over 5 days weekly or long-course RT with 15-25 fractions over 5 days weekly along with oral capecitabine twice daily on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks following RT
|
|---|---|
|
Cardiac disorders
Ventricular arrhythmia
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
3/42 • Number of events 6 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Cardiac disorders
Sinus tachycardia
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Cardiac disorders
Atrial flutter
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Eye disorders
Blurred vision
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Nausea
|
78.6%
33/42 • Number of events 50 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
30/42 • Number of events 39 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
12/42 • Number of events 14 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Abdominal pain
|
23.8%
10/42 • Number of events 11 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
16.7%
7/42 • Number of events 10 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
7/42 • Number of events 7 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Constipation
|
14.3%
6/42 • Number of events 10 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Bloating
|
14.3%
6/42 • Number of events 8 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Dyspepsia
|
11.9%
5/42 • Number of events 6 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.4%
1/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Gingival pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
Fatigue
|
61.9%
26/42 • Number of events 39 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
Edema limbs
|
11.9%
5/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
Fever
|
9.5%
4/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
Chills
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
Flu like symptoms
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
Infusion related reaction
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
Non-cardiac chest pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
General disorders
Paresthesia
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
9.5%
4/42 • Number of events 4 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Biliary tract infection
|
4.8%
2/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Appendicitis
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Sepsis
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Skin infection
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Hepatic infection
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Lung infection
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Shingles
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Infections and infestations
Thrush
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.4%
1/42 • Number of events 9 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Injury, poisoning and procedural complications
Bruising
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Investigations
Neutrophil count decreased
|
23.8%
10/42 • Number of events 12 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
6/42 • Number of events 6 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Investigations
Alkaline phosphatase increased
|
11.9%
5/42 • Number of events 6 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Investigations
Alanine aminotransferase increased
|
11.9%
5/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Investigations
Blood bilirubin increased
|
9.5%
4/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Investigations
Platelet count decreased
|
9.5%
4/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Investigations
Weight loss
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Investigations
Creatinine increased
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Hypokalemia
|
31.0%
13/42 • Number of events 20 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
7/42 • Number of events 10 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
7/42 • Number of events 8 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Paresthesia
|
11.9%
5/42 • Number of events 6 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
9.5%
4/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
9.5%
4/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
9.5%
4/42 • Number of events 4 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
4/42 • Number of events 4 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
2/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Infusion related reaction
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
59.5%
25/42 • Number of events 34 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Dysgeusia
|
28.6%
12/42 • Number of events 12 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Dizziness
|
19.0%
8/42 • Number of events 9 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
11.9%
5/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Headache
|
9.5%
4/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Dysphagia
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Cognitive disturbance
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Concentration impairment
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Dysarthria
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Neuralgia
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Presyncope
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Psychiatric disorders
Insomnia
|
21.4%
9/42 • Number of events 12 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Psychiatric disorders
Confusion
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Renal and urinary disorders
Urinary tract infection
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.9%
5/42 • Number of events 5 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.5%
4/42 • Number of events 4 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Vascular disorders
Capillary leak syndrome
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
4.8%
2/42 • Number of events 4 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.4%
1/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.0%
8/42 • Number of events 8 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
9.5%
4/42 • Number of events 4 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
2.4%
1/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Vascular disorders
Hypotension
|
9.5%
4/42 • Number of events 4 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Number of events 3 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
|
Vascular disorders
Flushing
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events were collected from start of first dose of study treatment up to and including 30 days following the date of last dose of study treatment.
The safety analysis set includes all enrolled participants who received at least 1 dose of systemic chemotherapy
|
Additional Information
Dr. Charles Lopez, Professor
Oregon Health & Science University
Phone: 503-494-1080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place