Trial Outcomes & Findings for Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer (NCT NCT00185588)
NCT ID: NCT00185588
Last Updated: 2014-09-15
Results Overview
For the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
12 months
Results posted on
2014-09-15
Participant Flow
Participant milestones
| Measure |
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
6
|
17
|
|
Overall Study
COMPLETED
|
3
|
2
|
0
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
6
|
4
|
Reasons for withdrawal
| Measure |
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250
n=6 Participants
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250
n=4 Participants
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500
n=6 Participants
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
n=17 Participants
Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
69 years
n=7 Participants
|
70 years
n=5 Participants
|
55 years
n=4 Participants
|
58 years
n=21 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
17 participants
n=4 Participants
|
33 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsFor the purposes of an Intent-to-Treat (ITT) analysis, Time-to-Treatment Failure (TTF) was defined as the time from treatment initiation to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, lost-to-follow-up, or death. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).
Outcome measures
| Measure |
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250
n=6 Participants
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250
n=4 Participants
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500
n=6 Participants
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
n=17 Participants
Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
|---|---|---|---|---|
|
Time-to-Treatment Failure (Intent-To-Treat Analysis)
|
4.9 months
Interval 3.8 to 9.5
|
2.7 months
Interval 0.7 to 9.8
|
2.2 months
Interval 0.7 to 5.6
|
3.7 months
Interval 0.7 to 10.4
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Evaluable subset of subjects that terminated from the study due to disease progression (endpoint). No participants were analyzed in the "Stage 1 Dose Exploration 2 - Gemcitabine 850 + Vatalanib 2 x 250 / 2 x 500 group" because no evaluable participants progressed within 12 months.
Represents the evaluable subset of subjects that terminated from the study due to disease progression (endpoint). Does not include any other form of treatment failure, nor lost-to-follow-up.
Outcome measures
| Measure |
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250
n=3 Participants
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250
n=2 Participants
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
n=13 Participants
Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
|---|---|---|---|---|
|
Time-to-Progression, Evaluable Patients
|
4.4 months
Interval 3.8 to 6.0
|
6.0 months
Interval 2.1 to 9.8
|
—
|
3.2 months
Interval 0.7 to 8.3
|
Adverse Events
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250
Serious events: 4 serious events
Other events: 3 other events
Deaths: 0 deaths
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250
n=6 participants at risk
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250
n=4 participants at risk
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500
n=6 participants at risk
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
n=17 participants at risk
Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
0.00%
0/6
|
5.9%
1/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
23.5%
4/17 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain-intractable pain
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 3
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/17
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 3
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
General disorders
Fever
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Hepatobiliary disorders
Obstructed bile duct, stent placement
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Neutropenia ANC 210
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Bladder
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Infections and infestations - not specified
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Infections and infestations
Urinary tract NOS
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Lung Infection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
11.8%
2/17 • Number of events 3
|
|
Investigations
Platelet count decreased
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 2
|
|
Investigations
White blood cell decreased
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Number of events 3
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
0.00%
0/17
|
|
Renal and urinary disorders
Urinary tract obstruction
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 2
|
0.00%
0/6
|
0.00%
0/17
|
|
Vascular disorders
Thromboembolic event
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Vascular disorders
Thromboembolic event-DVT
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
Other adverse events
| Measure |
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250
n=6 participants at risk
Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250
n=4 participants at risk
Gemcitabine 850 mg/m2 + vatalanib 1250 mg
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500
n=6 participants at risk
Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
n=17 participants at risk
Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily
Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12
Gemcitabine: 850 mg/m2
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Number of events 13
|
25.0%
1/4 • Number of events 4
|
50.0%
3/6 • Number of events 3
|
29.4%
5/17 • Number of events 12
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Cardiac disorders
Cardiac disorders - not specified
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders-not specified
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
Blurred vision
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
5.9%
1/17 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
6/6 • Number of events 11
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
58.8%
10/17 • Number of events 16
|
|
Gastrointestinal disorders
Constipation
|
66.7%
4/6 • Number of events 6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
52.9%
9/17 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
17.6%
3/17 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
17.6%
3/17 • Number of events 6
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
1/6 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorders -not specified
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
17.6%
3/17 • Number of events 3
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
70.6%
12/17 • Number of events 17
|
|
Gastrointestinal disorders
Stomach pain
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
35.3%
6/17 • Number of events 9
|
|
General disorders
Chills
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 3
|
|
General disorders
Edema face
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 6
|
50.0%
2/4 • Number of events 4
|
66.7%
4/6 • Number of events 7
|
64.7%
11/17 • Number of events 17
|
|
General disorders
Fever
|
66.7%
4/6 • Number of events 5
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
17.6%
3/17 • Number of events 6
|
|
General disorders
Injection site reaction
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 6
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
Urinary tract NOS
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Infections and infestations
Skin infection
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 6
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
17.6%
3/17 • Number of events 5
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
29.4%
5/17 • Number of events 7
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
35.3%
6/17 • Number of events 10
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 2
|
|
Investigations
Creatinine increased
|
0.00%
0/6
|
0.00%
0/4
|
33.3%
2/6 • Number of events 3
|
0.00%
0/17
|
|
Investigations
INR increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Investigations
Neutrophil count decreased
|
83.3%
5/6 • Number of events 11
|
75.0%
3/4 • Number of events 6
|
33.3%
2/6 • Number of events 3
|
29.4%
5/17 • Number of events 6
|
|
Investigations
Platelet count decreased
|
66.7%
4/6 • Number of events 9
|
25.0%
1/4 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
29.4%
5/17 • Number of events 9
|
|
Investigations
Weight gain
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Investigations
Weight loss
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
17.6%
3/17 • Number of events 3
|
|
Investigations
White blood cell decreased
|
50.0%
3/6 • Number of events 13
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
29.4%
5/17 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
4/6 • Number of events 5
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
35.3%
6/17 • Number of events 7
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 7
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
17.6%
3/17 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 3
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 3
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
4/6 • Number of events 4
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
29.4%
5/17 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder-not specified
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
3/6 • Number of events 3
|
0.00%
0/4
|
50.0%
3/6 • Number of events 3
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
11.8%
2/17 • Number of events 3
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Nervous system disorders - not specified
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/17
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
17.6%
3/17 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
33.3%
2/6 • Number of events 3
|
17.6%
3/17 • Number of events 3
|
|
Renal and urinary disorders
Cystitis noninfective
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Renal and urinary disorders
Renal and urinary disorders - not specified
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Renal and urinary disorders
Urine discoloration
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
50.0%
3/6 • Number of events 5
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
33.3%
2/6 • Number of events 2
|
23.5%
4/17 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
11.8%
2/17 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
16.7%
1/6 • Number of events 2
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
16.7%
1/6 • Number of events 2
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1
|
25.0%
1/4 • Number of events 3
|
0.00%
0/6
|
17.6%
3/17 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - not specified
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
23.5%
4/17 • Number of events 5
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/17
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6
|
0.00%
0/4
|
0.00%
0/6
|
11.8%
2/17 • Number of events 2
|
Additional Information
George Albert Fisher, Associate Professor of Medicine, Stanford University
Stanford University
Phone: 650-725-9057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place