Trial Outcomes & Findings for Sorafenib + mFOLFOX for Hepatocellular Carcinoma (NCT NCT01775501)
NCT ID: NCT01775501
Last Updated: 2020-04-22
Results Overview
The median amount of time from the time of registration until disease progression. Disease progression was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
The amount of time from registration until disease progression or death, median duration 7.7 months
Results posted on
2020-04-22
Participant Flow
Participant milestones
| Measure |
FOLFOX + Sorafenib
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
FOLFOX + Sorafenib
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Overall Study
Discontinued prior to treatment
|
1
|
Baseline Characteristics
Sorafenib + mFOLFOX for Hepatocellular Carcinoma
Baseline characteristics by cohort
| Measure |
FOLFOX + Sorafenib
n=40 Participants
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The amount of time from registration until disease progression or death, median duration 7.7 monthsThe median amount of time from the time of registration until disease progression. Disease progression was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
FOLFOX + Sorafenib
n=40 Participants
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Time to Progression
|
7.7 Months
Interval 4.4 to 8.9
|
SECONDARY outcome
Timeframe: From the start of treatment until 30 days after the end of treatment, median duration of 10.7 monthsTo evaluate the tolerability and toxicities of FOLFOX-S regimen in this population of patients.
Outcome measures
| Measure |
FOLFOX + Sorafenib
n=40 Participants
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Number of Patients Experiencing Adverse Events
|
40 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOverall response rate is the number of participants that achieved either a complete or partial response according to RECIST 1.1 criteria. * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
FOLFOX + Sorafenib
n=39 Participants
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Overall Response Rate
|
7 Participants
|
SECONDARY outcome
Timeframe: From the start of treatment until disease progression or death, median duration of 232 daysThe median duration of time from the start of treatment until disease progression or death
Outcome measures
| Measure |
FOLFOX + Sorafenib
n=40 Participants
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Median Progression Free Survival
|
232 Days
Interval 118.0 to 306.0
|
SECONDARY outcome
Timeframe: From registration until death, median duration of 15.1 monthsThe duration of time from study registration until death.
Outcome measures
| Measure |
FOLFOX + Sorafenib
n=40 Participants
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Median Overall Survival
|
15.1 Months
Interval 7.9 to 16.9
|
SECONDARY outcome
Timeframe: From the time of treatment response until death or disease progression (median duration 172 days)The median amount of time from achieving a response (partial or complete) until disease progression, death, or loss to follow-up.
Outcome measures
| Measure |
FOLFOX + Sorafenib
n=40 Participants
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Duration of Response
|
172 Days
Interval 112.0 to
Upper limit of the confidence interval is not estimable due to an insufficient number of participants with events
|
Adverse Events
FOLFOX + Sorafenib
Serious events: 32 serious events
Other events: 40 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
FOLFOX + Sorafenib
n=40 participants at risk
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
15.0%
6/40 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Alkaline phosphatase increased
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Blood and lymphatic system disorders
Anemia
|
7.5%
3/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Aspartate aminotransferase increased
|
22.5%
9/40 • Number of events 12 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Bleeding (Epistaxis, Hematuria, Hematoma, Hemorrhoidal hemorrhage, Rectal hemorrhage)
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Blood bilirubin increased
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
General disorders
Fatigue
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Vascular disorders
Flushing
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Vascular disorders
Hypertension
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
2/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
32.5%
13/40 • Number of events 25 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Lipase increased
|
22.5%
9/40 • Number of events 11 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Lymphocyte count decreased
|
17.5%
7/40 • Number of events 12 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Mouth Sores
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Neutrophil count decreased
|
7.5%
3/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
7.5%
3/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Platelet count decreased
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Serum amylase increased
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.5%
1/40 • Number of events 1 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
Other adverse events
| Measure |
FOLFOX + Sorafenib
n=40 participants at risk
FOLFOX (Leucovorin, Fluorouracil and Oxaliplatin) + Sorafenib Sorafenib: orally, twice daily FOLFOX: injected via portacath once every two weeks
Leucovorin: 200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Fluorouracil: 5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin: 85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Sorafenib: 400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
57.5%
23/40 • Number of events 27 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Alanine aminotransferase increased
|
62.5%
25/40 • Number of events 53 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Alkaline phosphatase increased
|
67.5%
27/40 • Number of events 50 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Immune system disorders
Allergic reaction
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Blood and lymphatic system disorders
Anemia
|
55.0%
22/40 • Number of events 54 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Anorexia
|
60.0%
24/40 • Number of events 32 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
30/40 • Number of events 66 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.5%
7/40 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Bleeding (Epistaxis, Hematuria, Hematoma, Hemorrhoidal hemorrhage, Rectal hemorrhage)
|
12.5%
5/40 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Blood bilirubin increased
|
35.0%
14/40 • Number of events 40 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Cardiac disorders
Chest pain - cardiac
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
General disorders
Chills
|
12.5%
5/40 • Number of events 5 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Psychiatric disorders
Confusion
|
12.5%
5/40 • Number of events 9 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Constipation
|
45.0%
18/40 • Number of events 24 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.5%
13/40 • Number of events 16 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
5/40 • Number of events 7 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Psychiatric disorders
Depression
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Diarrhea
|
57.5%
23/40 • Number of events 50 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Nervous system disorders
Dizziness
|
20.0%
8/40 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Nervous system disorders
Dysgeusia
|
5.0%
2/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.5%
9/40 • Number of events 9 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
General disorders
Edema face
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
General disorders
Edema limbs
|
20.0%
8/40 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
3/40 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
General disorders
Fatigue
|
85.0%
34/40 • Number of events 65 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
General disorders
Fever
|
15.0%
6/40 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Vascular disorders
Flushing
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Frequent urination
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Nervous system disorders
Headache
|
22.5%
9/40 • Number of events 9 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
70.0%
28/40 • Number of events 124 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
4/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Vascular disorders
Hypertension
|
35.0%
14/40 • Number of events 21 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.0%
12/40 • Number of events 26 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
2/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
6/40 • Number of events 9 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.5%
7/40 • Number of events 15 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
42.5%
17/40 • Number of events 39 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
62.5%
25/40 • Number of events 73 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Increased LDH
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
INR increased
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Psychiatric disorders
Insomnia
|
27.5%
11/40 • Number of events 12 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Lipase increased
|
40.0%
16/40 • Number of events 31 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Lymphocyte count decreased
|
40.0%
16/40 • Number of events 47 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Nervous system disorders
Memory impairment
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Mouth Sores
|
27.5%
11/40 • Number of events 18 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
17.5%
7/40 • Number of events 8 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Nausea
|
67.5%
27/40 • Number of events 46 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Neutrophil count decreased
|
35.0%
14/40 • Number of events 21 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
2/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
General disorders
Pain
|
47.5%
19/40 • Number of events 42 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
32.5%
13/40 • Number of events 32 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
2/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
52.5%
21/40 • Number of events 35 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Platelet count decreased
|
62.5%
25/40 • Number of events 59 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
2/40 • Number of events 4 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
5/40 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
7.5%
3/40 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.5%
17/40 • Number of events 26 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders; other
|
12.5%
5/40 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Serum amylase increased
|
22.5%
9/40 • Number of events 20 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Vascular disorders
Thromboembolic event
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
5/40 • Number of events 6 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Infections and infestations
Urinary tract infection
|
5.0%
2/40 • Number of events 3 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Renal and urinary disorders
Urinary urgency
|
5.0%
2/40 • Number of events 2 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
11/40 • Number of events 15 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
Weight loss
|
20.0%
8/40 • Number of events 9 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
|
Investigations
White blood cell decreased
|
22.5%
9/40 • Number of events 22 • From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place