Trial Outcomes & Findings for mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma (NCT NCT04251715)
NCT ID: NCT04251715
Last Updated: 2026-06-25
Results Overview
Defined by unacceptable elevation in liver enzymes, or radiographic evidence of biliary sclerosis on computed tomography (CT)/magnetic resonance imaging (MRI) (as measured following the completion of 2 cycles of hepatic arterial infusion \[HAI\] in Treatment Period 2).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up to 6 months after starting HAI with floxuridine
Results posted on
2026-06-25
Participant Flow
Participants were recruited at Oregon Health and Science University, April 2021 through February 2024
Participant milestones
| Measure |
mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone With Systemic mFOLFIRI for Unresectable Liver-dominant Intrahepatic Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
mFOLFIRINOX, Floxuridine-DEX, mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=20 Participants
|
|
Age, Continuous
|
60.1 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after starting HAI with floxuridineDefined by unacceptable elevation in liver enzymes, or radiographic evidence of biliary sclerosis on computed tomography (CT)/magnetic resonance imaging (MRI) (as measured following the completion of 2 cycles of hepatic arterial infusion \[HAI\] in Treatment Period 2).
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Frequency of Abnormal Liver Function
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months after starting HAI with floxuridineDCR is defined as the percentage of patients who have achieved complete response (CR), partial response (PR), or stable disease (SD). Measured from beginning of Treatment Period 2 to end of Treatment Period 2 during treatment with HAI + systemic chemotherapy (SYS).
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Disease Control Rate (DCR) - During HAI+SYS
Disease Control Rate (DCR) - During HAI+SYS
|
100 percentage of participants
|
|
Disease Control Rate (DCR) - During HAI+SYS
Complete Response (CR)
|
0 percentage of participants
|
|
Disease Control Rate (DCR) - During HAI+SYS
Partial Response (SD)
|
100 percentage of participants
|
|
Disease Control Rate (DCR) - During HAI+SYS
Stable Disease (SD)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsMeasured from beginning of Treatment Period 1 to end of Treatment Period 2 (i.e., from the beginning of the entire treatment protocol until the end).
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
DCR - Entire Treatment
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 months after starting study interventionMeasured from beginning of Treatment Period 1 to end of Treatment Period 1 (i.e., during the treatment with oxaliplatin, irinotecan, and fluorouracil \[FOLFIRINOX\] alone).
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
DCR - FOLFIRINOX
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsMeasured from beginning of Treatment Period 1 to end of Treatment Period 2 (i.e., from the beginning of the entire treatment protocol until the end).
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Overall Response Rate (ORR)
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 months after starting study interventionMeasured from beginning of Treatment Period 1 to end of Treatment Period 1 (i.e., treatment with FOLFIRINOX alone).
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at End of Treatment Period 1
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 13.9 months after beginning of Treatment Period 2Measured from beginning of Treatment Period 2 to up to 1 year after the end of Treatment Period 2 (i.e., treatment with HAI Floxuridine + mFOLFIRI).
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) at End of Treatment Period 2
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 months after starting study interventionMeasured from start of study intervention up to 2 years after after starting starting study intervention
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Progression Free Survival (PFS)
|
18.3 months
Interval 6.1 to
Not Reached
|
SECONDARY outcome
Timeframe: Up to 3 years after starting study interventionMeasured from start of study intervention up to 3 years after after starting starting study intervention
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Overall Survival (OS)
|
34.9 months
Interval 34.9 to
Not reached
|
SECONDARY outcome
Timeframe: Up to 1 yearOutcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Proportion of Liver Toxicity in Participants Receiving HAI Floxuridine + Dexamethasone Therapy
|
40 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 9 weeks after surgeryDefined as complications occurring within 9 weeks following surgery and \>= grade III per the Clavien-Dindo classification system.
Outcome measures
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 Participants
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Frequency of Serious Post-operative Complications
|
0 percentage of participants
|
Adverse Events
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
mFOLFIRINOX Followed by Concurrent HAI-Floxuridine and mFOLFIRI
n=5 participants at risk
Treatment Period 1 - mFOLFIRINOX for 4 cycles (cycle = 14 days) Cycle 1
* Oxaliplatin 85 mg/m2 intravenously (iv) over 2 hours
* Folinic acid 400 mg/m2 iv over 2 hours
* Irinotecan 144 mg/m2 iv over 90 minutes
* Fluorouracil 2,400 mg/m2 continuous infusion over 46 hours
* Dosages on Cycle 2, 3, and 4 will be reduced by 25%
Treatment Period 2 - HAI delivery of floxuridine + mFOLFIRI for 2 cycles (cycle = 28 days)
* Floxuridine-DEX (with heparin and saline) - 0.12 mg/kg/day; via HAI pump, adjusted for weight and flow rate
* mFOLFIRI on Day 15
* Irinotecan 150 mg/m2 iv over 30 minutes to 1 hour
* Folinic acid 400mg/m2 iv over 30 minutes to 1 hour
* 5-FU 1200 mg/m2 continuous infusion over 46 hours
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Gastrointestinal disorders
Mucositis oral
|
40.0%
2/5 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • Number of events 4 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
General disorders and administration site conditions
Fatigue
|
60.0%
3/5 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
General disorders and administration site conditions
Fever
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
General disorders and administration site conditions
Mucositis oral
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
General disorders and administration site conditions
Pain
|
40.0%
2/5 • Number of events 2 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Nervous system disorders
Lightheadedness
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
100.0%
5/5 • Number of events 5 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • All Adverse Events were collected from initiation of study drug to a minimum of 7 days from end of treatment, up to 30 days. All Serious Adverse Events collected from on treatment date to within 30 days of discontinuation of dosing or until patient begins another anti-cancer therapy, up to 30 days. Deaths were assessed for up to 3 years for overall survival.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place