Trial Outcomes & Findings for Vorinostat, Fluorouracil, and Leucovorin Calcium in Treating Patients With Metastatic Colorectal Cancer That Has Not Responded to Previous Treatment (NCT NCT00942266)
NCT ID: NCT00942266
Last Updated: 2014-06-23
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
At 2 months
Results posted on
2014-06-23
Participant Flow
Participant milestones
| Measure |
Arm I: Low-dose Vorinostat
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
15
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
15
|
Reasons for withdrawal
| Measure |
Arm I: Low-dose Vorinostat
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Disease Progression
|
38
|
11
|
|
Overall Study
Failure to thrive and pt withdrawal
|
0
|
1
|
|
Overall Study
Intercurrent illness
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
medical deterioration (pneumonia)
|
0
|
1
|
Baseline Characteristics
Vorinostat, Fluorouracil, and Leucovorin Calcium in Treating Patients With Metastatic Colorectal Cancer That Has Not Responded to Previous Treatment
Baseline characteristics by cohort
| Measure |
Arm I: Low-dose Vorinostat
n=43 Participants
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
n=15 Participants
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
61.1 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
60.6 years
STANDARD_DEVIATION 10.1 • n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At 2 monthsPopulation: All treated and eligible patients; per protocol
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I: Low-dose Vorinostat
n=43 Participants
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
n=15 Participants
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Disease Control Rate (Stable Disease or Objective Response)
|
53 percentage of participants
Interval 38.0 to 68.0
|
53 percentage of participants
Interval 28.0 to 78.0
|
SECONDARY outcome
Timeframe: Every 8 weeks, up to 100 weeks.Population: All treated and eligible patients; per protocol
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm I: Low-dose Vorinostat
n=43 Participants
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
n=15 Participants
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Median Progression-free Survival
|
2.4 months
Interval 1.8 to 3.6
|
2.9 months
Interval 1.6 to 5.6
|
SECONDARY outcome
Timeframe: Every 8 weeks; up to 100 weeks.Population: All treated and eligible patients; per protocol
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I: Low-dose Vorinostat
n=43 Participants
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
n=15 Participants
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Response Rate
|
2.3 percentage of participants
Interval 0.0 to 6.8
|
100 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: DailyPopulation: All treated and eligible patients; per protocol
Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.
Outcome measures
| Measure |
Arm I: Low-dose Vorinostat
n=43 Participants
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
n=15 Participants
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Toxicity
|
42 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Every 12 weeksPopulation: All treated and eligible patients; per protocol
Outcome measures
| Measure |
Arm I: Low-dose Vorinostat
n=43 Participants
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
n=15 Participants
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Overall Survival
|
6.5 months
Interval 4.8 to 7.8
|
6.7 months
Interval 3.0 to 21.9
|
SECONDARY outcome
Timeframe: day 2 (cycle 1)Population: Vorinostat PKs were be performed on day 2 of vorinostat in the first 10 patients of each arm treated at RPCI
Blood samples (5 ml of blood each) will be collected in red-top vacutainers (no anticoagulant) at 0 (pre- vorinostat), 0.5, 1, 2, 3, 4, 6, and 8 hours after the vorinostat dose on the first day of 5-FU infusion on cycle 1 (day 2 of cycle 1). Mean area under the curve is presented with 95% CI.
Outcome measures
| Measure |
Arm I: Low-dose Vorinostat
n=10 Participants
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
n=10 Participants
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Vorinostat Pharmacokinetics
|
12.6 hr∙μM
Interval 4.9 to 38.4
|
14.7 hr∙μM
Interval 4.5 to 42.7
|
SECONDARY outcome
Timeframe: Day 1Population: All treated and eligible patients
Blood samples will be collected for determination of plasma 5-FU steady state concentration at 6 hours after start of 5-FU continuous infusion. The mean per treatment arm are presented.
Outcome measures
| Measure |
Arm I: Low-dose Vorinostat
n=12 Participants
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II: High-dose Vorinostat
n=15 Participants
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Fluorouracil Steady-state Pharmacokinetics
|
389.4 ng/ml
Interval 328.9 to 449.9
|
423.5 ng/ml
Interval 339.0 to 508.0
|
Adverse Events
Arm I
Serious events: 12 serious events
Other events: 42 other events
Deaths: 0 deaths
Arm II
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=43 participants at risk
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II
n=15 participants at risk
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
4.7%
2/43 • Number of events 15
|
6.7%
1/15 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
2/43 • Number of events 12
|
6.7%
1/15 • Number of events 8
|
|
Hepatobiliary disorders
Cholangitis
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Infections and infestations
Infection
|
2.3%
1/43 • Number of events 8
|
6.7%
1/15 • Number of events 4
|
|
Infections and infestations
Pneumonia
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
|
Investigations
Troponin I increased
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Nervous system disorders
Convulsion
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Number of events 3
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.7%
2/43 • Number of events 8
|
0.00%
0/15
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
Other adverse events
| Measure |
Arm I
n=43 participants at risk
Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
Arm II
n=15 participants at risk
Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
fluorouracil: Given IV
leucovorin calcium: Given IV
vorinostat: Given orally
pharmacological study: Correlative study
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
23.3%
10/43 • Number of events 51
|
13.3%
2/15 • Number of events 7
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.6%
5/43 • Number of events 24
|
6.7%
1/15 • Number of events 4
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.6%
11/43 • Number of events 55
|
46.7%
7/15 • Number of events 74
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.7%
2/43 • Number of events 8
|
20.0%
3/15 • Number of events 11
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
|
Cardiac disorders
Tachycardia
|
2.3%
1/43 • Number of events 8
|
0.00%
0/15
|
|
Eye disorders
Cataract
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Gastrointestinal disorders
Cheilitis
|
7.0%
3/43 • Number of events 12
|
0.00%
0/15
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • Number of events 3
|
6.7%
1/15 • Number of events 4
|
|
Gastrointestinal disorders
Dental caries
|
2.3%
1/43 • Number of events 3
|
0.00%
0/15
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
6/43 • Number of events 24
|
6.7%
1/15 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
11.6%
5/43 • Number of events 20
|
0.00%
0/15
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/43
|
6.7%
1/15 • Number of events 8
|
|
Gastrointestinal disorders
Nausea
|
27.9%
12/43 • Number of events 63
|
60.0%
9/15 • Number of events 40
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Gastrointestinal disorders
Stomatitis
|
4.7%
2/43 • Number of events 8
|
0.00%
0/15
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
6/43 • Number of events 24
|
13.3%
2/15 • Number of events 8
|
|
General disorders
Fatigue
|
25.6%
11/43 • Number of events 72
|
33.3%
5/15 • Number of events 36
|
|
General disorders
Mucosal inflammation
|
9.3%
4/43 • Number of events 16
|
20.0%
3/15 • Number of events 24
|
|
General disorders
Oedema peripheral
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
General disorders
Pain
|
7.0%
3/43 • Number of events 12
|
0.00%
0/15
|
|
Hepatobiliary disorders
Cholangitis
|
4.7%
2/43 • Number of events 8
|
0.00%
0/15
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.7%
2/43 • Number of events 8
|
0.00%
0/15
|
|
Infections and infestations
Cystitis
|
2.3%
1/43 • Number of events 3
|
0.00%
0/15
|
|
Infections and infestations
Herpes virus infection
|
2.3%
1/43 • Number of events 8
|
0.00%
0/15
|
|
Infections and infestations
Infection
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Infections and infestations
Localised infection
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Infections and infestations
Sinusitis
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Injury, poisoning and procedural complications
Fracture
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Investigations
Alanine aminotransferase increased
|
2.3%
1/43 • Number of events 8
|
0.00%
0/15
|
|
Investigations
Aspartate aminotransferase increased
|
7.0%
3/43 • Number of events 20
|
20.0%
3/15 • Number of events 12
|
|
Investigations
Blood albumin decreased
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Investigations
Blood alkaline phosphatase
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
|
Investigations
Blood alkaline phosphatase increased
|
4.7%
2/43 • Number of events 8
|
20.0%
3/15 • Number of events 12
|
|
Investigations
Blood creatinine increased
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 7
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.3%
1/43 • Number of events 3
|
0.00%
0/15
|
|
Investigations
Electrocardiogram QT corrected interval
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/43
|
26.7%
4/15 • Number of events 17
|
|
Investigations
Haemoglobin decreased
|
2.3%
1/43 • Number of events 8
|
26.7%
4/15 • Number of events 32
|
|
Investigations
International normalised ratio increased
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Investigations
Lipase increased
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Investigations
Troponin I increased
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Investigations
Urine colour abnormal
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Investigations
Weight decreased
|
4.7%
2/43 • Number of events 8
|
6.7%
1/15 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
23.3%
10/43 • Number of events 48
|
33.3%
5/15 • Number of events 20
|
|
Metabolism and nutrition disorders
Dehydration
|
7.0%
3/43 • Number of events 12
|
6.7%
1/15 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.3%
4/43 • Number of events 28
|
26.7%
4/15 • Number of events 28
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.3%
4/43 • Number of events 23
|
13.3%
2/15 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.3%
4/43 • Number of events 24
|
13.3%
2/15 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.7%
2/43 • Number of events 12
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
4/43 • Number of events 16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Nervous system disorders
Convulsion
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Nervous system disorders
Dizziness
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/43
|
20.0%
3/15 • Number of events 12
|
|
Nervous system disorders
Headache
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Psychiatric disorders
Depression
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Psychiatric disorders
Insomnia
|
4.7%
2/43 • Number of events 8
|
6.7%
1/15 • Number of events 4
|
|
Renal and urinary disorders
Enuresis
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Renal and urinary disorders
Pollakiuria
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/43 • Number of events 4
|
6.7%
1/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.0%
3/43 • Number of events 11
|
6.7%
1/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.7%
2/43 • Number of events 8
|
6.7%
1/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/43 • Number of events 6
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.7%
2/43 • Number of events 8
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/43
|
6.7%
1/15 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
9.3%
4/43 • Number of events 24
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Vascular disorders
Deep vein thrombosis
|
9.3%
4/43 • Number of events 16
|
0.00%
0/15
|
|
Vascular disorders
Hypertension
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
|
Vascular disorders
Phlebitis superficial
|
2.3%
1/43 • Number of events 4
|
0.00%
0/15
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place