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Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00185588
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
George Albert Fisher, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Vatalanib
Drug: Gemcitabine
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Hide Arm/Group Description

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

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

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

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

Period Title: Overall Study
Started 6 4 6 17
Completed 3 2 0 13
Not Completed 3 2 6 4
Reason Not Completed
Adverse Event             3             1             4             2
Lost to Follow-up             0             0             1             2
Withdrawal by Subject             0             1             0             0
Physician Decision             0             0             1             0
Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500 Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 6 4 6 17 33
Hide Baseline Analysis Population Description
33 adult patients with advanced pancreatic cancer
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 4 participants 6 participants 17 participants 33 participants
55
(40 to 76)
69
(53 to 82)
70
(53 to 75)
55
(40 to 79)
58
(40 to 82)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 6 participants 17 participants 33 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
2
  50.0%
2
  33.3%
13
  76.5%
22
  66.7%
>=65 years
1
  16.7%
2
  50.0%
4
  66.7%
4
  23.5%
11
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 6 participants 17 participants 33 participants
Female
4
  66.7%
2
  50.0%
2
  33.3%
7
  41.2%
15
  45.5%
Male
2
  33.3%
2
  50.0%
4
  66.7%
10
  58.8%
18
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 4 participants 6 participants 17 participants 33 participants
6 4 6 17 33
1.Primary Outcome
Title Time-to-Treatment Failure (Intent-To-Treat Analysis)
Hide Description

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).

Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 6 4 6 17
Median (Full Range)
Unit of Measure: months
4.9
(3.8 to 9.5)
2.7
(0.7 to 9.8)
2.2
(0.7 to 5.6)
3.7
(0.7 to 10.4)
2.Secondary Outcome
Title Time-to-Progression, Evaluable Patients
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Hide Arm/Group Description:

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

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

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

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 Number of Participants Analyzed 3 2 0 13
Median (Full Range)
Unit of Measure: months
4.4
(3.8 to 6.0)
6.0
(2.1 to 9.8)
3.2
(0.7 to 8.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      4/4 (100.00%)      4/6 (66.67%)      10/17 (58.82%)    
Blood and lymphatic system disorders         
Anemia  1/6 (16.67%)  1 1/4 (25.00%)  2 0/6 (0.00%)  0 1/17 (5.88%)  2
Febrile neutropenia  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  2
Hemolysis  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders         
Abdominal pain  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 4/17 (23.53%)  4
Abdominal pain-intractable pain  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Ascites  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Colitis  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Constipation  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Diarrhea  2/6 (33.33%)  3 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Dyspepsia  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Enterocolitis  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Gastritis  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Hemorrhoids  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Rectal hemorrhage  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Vomiting  0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/17 (0.00%)  0
General disorders         
Edema limbs  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Fatigue  2/6 (33.33%)  3 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Fever  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Hepatobiliary disorders         
Obstructed bile duct, stent placement  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations         
Neutropenia ANC 210  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Bladder  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations - not specified  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Urinary tract NOS  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Urosepsis  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Lung Infection  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Urinary tract infection  0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/17 (0.00%)  0
Injury, poisoning and procedural complications         
Arterial injury  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Vascular access complication  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Alkaline phosphatase increased  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Blood bilirubin increased  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Neutrophil count decreased  2/6 (33.33%)  4 1/4 (25.00%)  1 1/6 (16.67%)  1 2/17 (11.76%)  3
Platelet count decreased  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  2
White blood cell decreased  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Dehydration  2/6 (33.33%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Hyperglycemia  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Hypokalemia  2/6 (33.33%)  3 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Hyponatremia  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Pain in extremity  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Nervous system disorders         
Peripheral sensory neuropathy  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Renal and urinary disorders         
Proteinuria  1/6 (16.67%)  2 0/4 (0.00%)  0 1/6 (16.67%)  2 0/17 (0.00%)  0
Urinary tract obstruction  1/6 (16.67%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Vascular disorders         
Hypertension  1/6 (16.67%)  1 1/4 (25.00%)  2 0/6 (0.00%)  0 0/17 (0.00%)  0
Thromboembolic event  2/6 (33.33%)  2 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Thromboembolic event-DVT  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
1
Term from vocabulary, CTCAEv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250 Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250 Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500 Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      3/4 (75.00%)      6/6 (100.00%)      14/17 (82.35%)    
Blood and lymphatic system disorders         
Anemia  4/6 (66.67%)  13 1/4 (25.00%)  4 3/6 (50.00%)  3 5/17 (29.41%)  12
Febrile neutropenia  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 2/17 (11.76%)  2
Cardiac disorders         
Cardiac disorders - not specified  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Ear and labyrinth disorders         
Ear and labyrinth disorders-not specified  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Eye disorders         
Blurred vision  0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders         
Abdominal distension  1/6 (16.67%)  1 1/4 (25.00%)  1 3/6 (50.00%)  3 1/17 (5.88%)  7
Abdominal pain  6/6 (100.00%)  11 0/4 (0.00%)  0 1/6 (16.67%)  1 10/17 (58.82%)  16
Constipation  4/6 (66.67%)  6 0/4 (0.00%)  0 1/6 (16.67%)  1 9/17 (52.94%)  10
Diarrhea  3/6 (50.00%)  6 0/4 (0.00%)  0 1/6 (16.67%)  1 3/17 (17.65%)  6
Dyspepsia  0/6 (0.00%)  0 0/4 (0.00%)  0 2/6 (33.33%)  2 3/17 (17.65%)  6
Esophagitis  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Flatulence  1/6 (16.67%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Gastric stenosis  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Gastric ulcer  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Gastritis  1/6 (16.67%)  2 1/4 (25.00%)  1 1/6 (16.67%)  1 1/17 (5.88%)  1
Gastrointestinal disorders -not specified  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 3/17 (17.65%)  3
Hemorrhoids  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Mucositis oral  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Nausea  3/6 (50.00%)  4 1/4 (25.00%)  1 2/6 (33.33%)  2 12/17 (70.59%)  17
Stomach pain  2/6 (33.33%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Toothache  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Vomiting  2/6 (33.33%)  2 0/4 (0.00%)  0 1/6 (16.67%)  2 6/17 (35.29%)  9
General disorders         
Chills  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  3
Edema face  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Edema limbs  1/6 (16.67%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1 1/17 (5.88%)  1
Fatigue  3/6 (50.00%)  6 2/4 (50.00%)  4 4/6 (66.67%)  7 11/17 (64.71%)  17
Fever  4/6 (66.67%)  5 0/4 (0.00%)  0 1/6 (16.67%)  2 3/17 (17.65%)  6
Injection site reaction  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Pain  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  6
Hepatobiliary disorders         
Hepatic failure  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations         
Urinary tract NOS  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Skin infection  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Injury, poisoning and procedural complications         
Bruising  1/6 (16.67%)  1 1/4 (25.00%)  1 0/6 (0.00%)  0 0/17 (0.00%)  0
Vascular access complication  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Wound dehiscence  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1/6 (16.67%)  6 0/4 (0.00%)  0 2/6 (33.33%)  2 3/17 (17.65%)  5
Alkaline phosphatase increased  1/6 (16.67%)  1 1/4 (25.00%)  1 1/6 (16.67%)  2 5/17 (29.41%)  7
Aspartate aminotransferase increased  1/6 (16.67%)  1 0/4 (0.00%)  0 2/6 (33.33%)  2 6/17 (35.29%)  10
Blood bilirubin increased  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  2
Creatinine increased  0/6 (0.00%)  0 0/4 (0.00%)  0 2/6 (33.33%)  3 0/17 (0.00%)  0
INR increased  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Neutrophil count decreased  5/6 (83.33%)  11 3/4 (75.00%)  6 2/6 (33.33%)  3 5/17 (29.41%)  6
Platelet count decreased  4/6 (66.67%)  9 1/4 (25.00%)  3 3/6 (50.00%)  3 5/17 (29.41%)  9
Weight gain  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Weight loss  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 3/17 (17.65%)  3
White blood cell decreased  3/6 (50.00%)  13 0/4 (0.00%)  0 2/6 (33.33%)  2 5/17 (29.41%)  6
Metabolism and nutrition disorders         
Anorexia  4/6 (66.67%)  5 0/4 (0.00%)  0 2/6 (33.33%)  2 6/17 (35.29%)  7
Dehydration  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Hyperglycemia  1/6 (16.67%)  7 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Hyperkalemia  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Hypoalbuminemia  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  2 3/17 (17.65%)  4
Hypoglycemia  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Hypokalemia  1/6 (16.67%)  3 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Hyponatremia  1/6 (16.67%)  3 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 1/17 (5.88%)  1
Back pain  4/6 (66.67%)  4 0/4 (0.00%)  0 1/6 (16.67%)  1 5/17 (29.41%)  5
Chest wall pain  1/6 (16.67%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1 1/17 (5.88%)  1
Generalized muscle weakness  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Muscle weakness lower limb  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Musculoskeletal and connective tissue disorder-not specified  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Myalgia  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Neck pain  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Pain in extremity  3/6 (50.00%)  3 0/4 (0.00%)  0 3/6 (50.00%)  3 0/17 (0.00%)  0
Trismus  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders         
Dizziness  1/6 (16.67%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1 2/17 (11.76%)  3
Headache  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Memory impairment  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders - not specified  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Peripheral motor neuropathy  0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 1/17 (5.88%)  1
Syncope  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Tremor  0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/17 (0.00%)  0
Psychiatric disorders         
Anxiety  1/6 (16.67%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Confusion  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Depression  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 3/17 (17.65%)  3
Insomnia  0/6 (0.00%)  0 1/4 (25.00%)  1 2/6 (33.33%)  3 3/17 (17.65%)  3
Renal and urinary disorders         
Cystitis noninfective  1/6 (16.67%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Proteinuria  0/6 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 2/17 (11.76%)  2
Renal and urinary disorders - not specified  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Urine discoloration  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Reproductive system and breast disorders         
Pelvic pain  1/6 (16.67%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1/6 (16.67%)  1 1/4 (25.00%)  1 3/6 (50.00%)  5 1/17 (5.88%)  1
Dyspnea  2/6 (33.33%)  2 0/4 (0.00%)  0 2/6 (33.33%)  2 4/17 (23.53%)  4
Epistaxis  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 2/17 (11.76%)  2
Hiccups  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 1/17 (5.88%)  1
Pleuritic pain  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Sinus disorder  2/6 (33.33%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Voice alteration  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1/6 (16.67%)  1 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Hyperhidrosis  2/6 (33.33%)  2 0/4 (0.00%)  0 1/6 (16.67%)  2 0/17 (0.00%)  0
Pain of skin  1/6 (16.67%)  2 0/4 (0.00%)  0 0/6 (0.00%)  0 0/17 (0.00%)  0
Rash maculo-papular  1/6 (16.67%)  1 1/4 (25.00%)  3 0/6 (0.00%)  0 3/17 (17.65%)  5
Skin and subcutaneous tissue disorders - not specified  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/17 (5.88%)  1
Vascular disorders         
Hypertension  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 4/17 (23.53%)  5
Hypotension  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
Phlebitis  0/6 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/17 (0.00%)  0
Thromboembolic event  0/6 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 2/17 (11.76%)  2
1
Term from vocabulary, CTCAEv4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: George Albert Fisher, Associate Professor of Medicine, Stanford University
Organization: Stanford University
Phone: 650-725-9057
Responsible Party: George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier: NCT00185588     History of Changes
Other Study ID Numbers: IRB-06999
95533 ( Other Identifier: Stanford University Alternate IRB Number )
CPTK787AUS08 ( Other Identifier: Novartis )
PANC0002 ( Other Identifier: OnCore )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: July 30, 2014
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014