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Trial record 66 of 159 for:    colon cancer AND Capecitabine AND Fluorouracil

A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin

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ClinicalTrials.gov Identifier: NCT01077739
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : August 7, 2014
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: fluorouracil (5FU)
Drug: leucovorin
Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Drug: oxaliplatin
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + 5-fluorouracil/Oxaliplatin/Leucovorin (FOLFOX)
Hide Arm/Group Description Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1; oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1; and capecitabine 1000 mg/m^2, orally (PO), twice daily (BID) on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression. Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-fluorouracil [5-FU] plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
Period Title: Overall Study
Started 25 50
Completed 20 40
Not Completed 5 10
Reason Not Completed
Premature withdrawal             1             3
Withdrawal by Subject             1             0
Death             0             3
Unacceptable toxicity             1             2
Not specified             2             2
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX Total
Hide Arm/Group Description Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression. Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 25 50 75
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: all enrolled participants who received at least 1 dose of the investigational and non-investigational products.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 50 participants 75 participants
59.6  (8.9) 64.9  (8.7) 63.1  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 50 participants 75 participants
Female
8
  32.0%
21
  42.0%
29
  38.7%
Male
17
  68.0%
29
  58.0%
46
  61.3%
1.Primary Outcome
Title Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression
Hide Description PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning 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. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.
Time Frame Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
Overall Number of Participants Analyzed 25 50
Median (95% Confidence Interval)
Unit of Measure: months
6.3
(4.1 to 7.6)
5.1
(3.8 to 6.0)
2.Secondary Outcome
Title PFS From the Start of First-Line Therapy
Hide Description PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.
Time Frame Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
Overall Number of Participants Analyzed 25 50
Median (95% Confidence Interval)
Unit of Measure: months
17.8
(14.1 to 19.4)
18.0
(15.0 to 19.9)
3.Secondary Outcome
Title Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR)
Hide Description

Percentage of participants with an overall response of CR or PR according to RECIST criteria.

CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Time Frame Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal, for up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with RECIST evaluations were included in the analysis.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
Overall Number of Participants Analyzed 22 47
Measure Type: Number
Unit of Measure: percentage of participants
27.3 6.4
4.Secondary Outcome
Title Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression
Hide Description Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration.
Time Frame Baseline, every 9 weeks until disease progression, at final visit or at withdrawal, for up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Number (n) equals (=) number of participants assessed for the given parameter at the specified visit.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX
Hide Arm/Group Description:
Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
Overall Number of Participants Analyzed 13 23
Geometric Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline bFGF (n=13,23) 6.8  (0.7) 6.1  (0.6)
bFGF, Prior to progression levels (n=12,18) 3.6  (0.9) 4.2  (0.7)
Baseline HGF (n=13,23) 133.0  (0.3) 186.0  (0.4)
HGF, Prior to progression levels (n=12,18) 187.3  (0.4) 230.3  (0.4)
Baseline PIGF (n=13,23) 29.8  (0.1) 26.3  (0.2)
PIGF, Prior to progression levels (n=12,18) 34.7  (0.1) 37.1  (0.2)
Time Frame Adverse events (AEs) were reported from Day 1 until 28 days after last dose of study medication for up to 24 months.
Adverse Event Reporting Description The safety population included all participants who received at least 1 dose of the investigational or non-investigational products.
 
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX
Hide Arm/Group Description Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression. Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
All-Cause Mortality
Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX
Affected / at Risk (%) Affected / at Risk (%)
Total   12/25 (48.00%)   18/50 (36.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  0/25 (0.00%)  1/50 (2.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/25 (4.00%)  1/50 (2.00%) 
Abdominal pain upper * 1  1/25 (4.00%)  1/50 (2.00%) 
Anal fistula * 1  1/25 (4.00%)  0/50 (0.00%) 
Colonic obstruction * 1  0/25 (0.00%)  1/50 (2.00%) 
Diarrhoea * 1  1/25 (4.00%)  2/50 (4.00%) 
Enteritis * 1  1/25 (4.00%)  0/50 (0.00%) 
Ileus * 1  0/25 (0.00%)  1/50 (2.00%) 
Intestinal perforation * 1  0/25 (0.00%)  1/50 (2.00%) 
Nausea * 1  0/25 (0.00%)  1/50 (2.00%) 
Vomiting * 1  1/25 (4.00%)  1/50 (2.00%) 
General disorders     
Asthenia * 1  1/25 (4.00%)  0/50 (0.00%) 
Device dislocation * 1  0/25 (0.00%)  1/50 (2.00%) 
Disease progression * 1  0/25 (0.00%)  1/50 (2.00%) 
Drug intolerance * 1  0/25 (0.00%)  1/50 (2.00%) 
General physical health deterioration * 1  0/25 (0.00%)  3/50 (6.00%) 
Idiosyncratic drug reaction * 1  0/25 (0.00%)  1/50 (2.00%) 
Obstruction * 1  1/25 (4.00%)  0/50 (0.00%) 
Pain * 1  0/25 (0.00%)  1/50 (2.00%) 
Infections and infestations     
Necrotising fasciitis * 1  0/25 (0.00%)  1/50 (2.00%) 
Perirectal abscess * 1  0/25 (0.00%)  1/50 (2.00%) 
Sepsis * 1  0/25 (0.00%)  1/50 (2.00%) 
Vaginal abscess * 1  1/25 (4.00%)  0/50 (0.00%) 
Injury, poisoning and procedural complications     
Drug toxicity * 1  2/25 (8.00%)  0/50 (0.00%) 
Fall * 1  1/25 (4.00%)  0/50 (0.00%) 
Jaw fracture * 1  1/25 (4.00%)  0/50 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/25 (4.00%)  1/50 (2.00%) 
Dehydration * 1  2/25 (8.00%)  1/50 (2.00%) 
Nervous system disorders     
Epilepsy * 1  1/25 (4.00%)  0/50 (0.00%) 
Psychiatric disorders     
Confusional state * 1  1/25 (4.00%)  0/50 (0.00%) 
Depression * 1  1/25 (4.00%)  0/50 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  0/25 (0.00%)  1/50 (2.00%) 
Hiccups * 1  1/25 (4.00%)  0/50 (0.00%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/25 (0.00%)  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab + Oxaliplatin + Capecitabine Bevacizumab + FOLFOX
Affected / at Risk (%) Affected / at Risk (%)
Total   24/25 (96.00%)   49/50 (98.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  1/25 (4.00%)  8/50 (16.00%) 
Leukopenia * 1  1/25 (4.00%)  4/50 (8.00%) 
Lymphopenia * 1  0/25 (0.00%)  1/50 (2.00%) 
Neutropenia * 1  4/25 (16.00%)  10/50 (20.00%) 
Thrombocytopenia * 1  4/25 (16.00%)  7/50 (14.00%) 
Cardiac disorders     
Angina pectoris * 1  1/25 (4.00%)  0/50 (0.00%) 
Arrhythmia * 1  0/25 (0.00%)  1/50 (2.00%) 
Arteriospasm coronary * 1  0/25 (0.00%)  1/50 (2.00%) 
Atrial fibrillation * 1  1/25 (4.00%)  0/50 (0.00%) 
Palpitation * 1  0/25 (0.00%)  1/50 (2.00%) 
Pericardial effusion * 1  0/25 (0.00%)  1/50 (2.00%) 
Tachycardia * 1  0/25 (0.00%)  1/50 (2.00%) 
Eye disorders     
Lacrimation increased * 1  1/25 (4.00%)  1/50 (2.00%) 
Gastrointestinal disorders     
Abdominal distension * 1  1/25 (4.00%)  0/50 (0.00%) 
Abdominal pain * 1  9/25 (36.00%)  13/50 (26.00%) 
Abdominal pain lower * 1  1/25 (4.00%)  0/50 (0.00%) 
Abdominal pain upper * 1  2/25 (8.00%)  3/50 (6.00%) 
Anal fistula * 1  0/25 (0.00%)  1/50 (2.00%) 
Anal haemorrhage * 1  1/25 (4.00%)  1/50 (2.00%) 
Aphthous stomatitis * 1  0/25 (0.00%)  1/50 (2.00%) 
Ascites * 1  1/25 (4.00%)  1/50 (2.00%) 
Colitis * 1  2/25 (8.00%)  0/50 (0.00%) 
Constipation * 1  4/25 (16.00%)  6/50 (12.00%) 
Diarrhoea * 1  14/25 (56.00%)  21/50 (42.00%) 
Duodenitis * 1  0/25 (0.00%)  1/50 (2.00%) 
Dyspepsia * 1  0/25 (0.00%)  7/50 (14.00%) 
Dysphagia * 1  1/25 (4.00%)  1/50 (2.00%) 
Epigastric discomfort * 1  0/25 (0.00%)  1/50 (2.00%) 
Faecaloma * 1  0/25 (0.00%)  1/50 (2.00%) 
Frequent bowel movements * 1  0/25 (0.00%)  1/50 (2.00%) 
Gastrointestinal motility disorder * 1  1/25 (4.00%)  0/50 (0.00%) 
Gastrooesophageal reflux disease * 1  0/25 (0.00%)  1/50 (2.00%) 
Haemorrhoids * 1  0/25 (0.00%)  1/50 (2.00%) 
Intestinal obstruction * 1  1/25 (4.00%)  0/50 (0.00%) 
Nausea * 1  10/25 (40.00%)  16/50 (32.00%) 
Oesophagitis * 1  1/25 (4.00%)  0/50 (0.00%) 
Oral disorder * 1  0/25 (0.00%)  1/50 (2.00%) 
Proctalgia * 1  0/25 (0.00%)  2/50 (4.00%) 
Rectal tenesmus * 1  0/25 (0.00%)  2/50 (4.00%) 
Small intestinal obstruction * 1  0/25 (0.00%)  1/50 (2.00%) 
Steatorrhoea * 1  1/25 (4.00%)  0/50 (0.00%) 
Stomatitis * 1  2/25 (8.00%)  4/50 (8.00%) 
Vomiting * 1  6/25 (24.00%)  5/50 (10.00%) 
General disorders     
Asthenia * 1  5/25 (20.00%)  7/50 (14.00%) 
Chest pain * 1  1/25 (4.00%)  1/50 (2.00%) 
Chills * 1  1/25 (4.00%)  1/50 (2.00%) 
Fatigue * 1  9/25 (36.00%)  22/50 (44.00%) 
Feeling cold * 1  1/25 (4.00%)  0/50 (0.00%) 
General physical health deterioration * 1  3/25 (12.00%)  0/50 (0.00%) 
Mucosal inflammation * 1  1/25 (4.00%)  2/50 (4.00%) 
Oedema * 1  1/25 (4.00%)  0/50 (0.00%) 
Oedema peripheral * 1  1/25 (4.00%)  1/50 (2.00%) 
Pain * 1  2/25 (8.00%)  4/50 (8.00%) 
Pyrexia * 1  3/25 (12.00%)  8/50 (16.00%) 
Systemic inflammatory response syndrome * 1  0/25 (0.00%)  1/50 (2.00%) 
Hepatobiliary disorders     
Hepatic pain * 1  0/25 (0.00%)  2/50 (4.00%) 
Hepatomegaly * 1  0/25 (0.00%)  1/50 (2.00%) 
Liver disorder * 1  0/25 (0.00%)  1/50 (2.00%) 
Immune system disorders     
Drug hypersensitivity * 1  2/25 (8.00%)  5/50 (10.00%) 
Hypersensitivity * 1  0/25 (0.00%)  1/50 (2.00%) 
Infections and infestations     
Anal abscess * 1  0/25 (0.00%)  1/50 (2.00%) 
Bronchitis * 1  0/25 (0.00%)  1/50 (2.00%) 
Escherichia infection * 1  0/25 (0.00%)  1/50 (2.00%) 
Eye infection * 1  1/25 (4.00%)  1/50 (2.00%) 
Febrile infection * 1  0/25 (0.00%)  1/50 (2.00%) 
Gastroenteritis * 1  0/25 (0.00%)  1/50 (2.00%) 
Infection * 1  1/25 (4.00%)  0/50 (0.00%) 
Lung infection * 1  1/25 (4.00%)  0/50 (0.00%) 
Nail infection * 1  0/25 (0.00%)  1/50 (2.00%) 
Nasopharyngitis * 1  0/25 (0.00%)  3/50 (6.00%) 
Paronychia * 1  1/25 (4.00%)  0/50 (0.00%) 
Pharyngitis * 1  0/25 (0.00%)  1/50 (2.00%) 
Respiratory tract infection * 1  0/25 (0.00%)  1/50 (2.00%) 
Rhinitis * 1  1/25 (4.00%)  0/50 (0.00%) 
Sinusitis * 1  0/25 (0.00%)  1/50 (2.00%) 
Tooth abscess * 1  0/25 (0.00%)  2/50 (4.00%) 
Tooth infection * 1  1/25 (4.00%)  1/50 (2.00%) 
Tracheitis * 1  1/25 (4.00%)  0/50 (0.00%) 
Upper respiratory tract infection * 1  1/25 (4.00%)  0/50 (0.00%) 
Urinary tract infection * 1  0/25 (0.00%)  2/50 (4.00%) 
Injury, poisoning and procedural complications     
Contusion * 1  1/25 (4.00%)  0/50 (0.00%) 
Investigations     
Blood alkaline phosphatase increased * 1  0/25 (0.00%)  1/50 (2.00%) 
Blood creatinine * 1  0/25 (0.00%)  1/50 (2.00%) 
Blood creatinine increased * 1  0/25 (0.00%)  1/50 (2.00%) 
Body temperature increased * 1  0/25 (0.00%)  1/50 (2.00%) 
Gamma-glutamyltransferase abnormal * 1  0/25 (0.00%)  1/50 (2.00%) 
Gamma-glutamyltransferase increased * 1  0/25 (0.00%)  3/50 (6.00%) 
Weight decreased * 1  3/25 (12.00%)  2/50 (4.00%) 
White blood cell count decreased * 1  0/25 (0.00%)  1/50 (2.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  9/25 (36.00%)  12/50 (24.00%) 
Dehydration * 1  1/25 (4.00%)  1/50 (2.00%) 
Gout * 1  1/25 (4.00%)  0/50 (0.00%) 
Hyperglycaemia * 1  1/25 (4.00%)  2/50 (4.00%) 
Hypoalbuminaemia * 1  0/25 (0.00%)  4/50 (8.00%) 
Hypocalcaemia * 1  0/25 (0.00%)  3/50 (6.00%) 
Hypokalaemia * 1  0/25 (0.00%)  4/50 (8.00%) 
Hypomagnesaemia * 1  0/25 (0.00%)  1/50 (2.00%) 
Hyponatraemia * 1  0/25 (0.00%)  2/50 (4.00%) 
Hypophosphataemia * 1  0/25 (0.00%)  1/50 (2.00%) 
Vitamin D deficiency * 1  1/25 (4.00%)  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/25 (4.00%)  2/50 (4.00%) 
Back pain * 1  3/25 (12.00%)  6/50 (12.00%) 
Flank pain * 1  0/25 (0.00%)  1/50 (2.00%) 
Muscle contracture * 1  1/25 (4.00%)  0/50 (0.00%) 
Muscle spasms * 1  0/25 (0.00%)  2/50 (4.00%) 
Muscular weakness * 1  1/25 (4.00%)  0/50 (0.00%) 
Musculoskeletal chest pain * 1  0/25 (0.00%)  1/50 (2.00%) 
Musculoskeletal pain * 1  1/25 (4.00%)  1/50 (2.00%) 
Myalgia * 1  1/25 (4.00%)  0/50 (0.00%) 
Osteoarthritis * 1  0/25 (0.00%)  1/50 (2.00%) 
Pain in extremity * 1  0/25 (0.00%)  3/50 (6.00%) 
Sensation of heaviness * 1  0/25 (0.00%)  1/50 (2.00%) 
Spinal osteoarthritis * 1  0/25 (0.00%)  1/50 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastatic pain * 1  0/25 (0.00%)  1/50 (2.00%) 
Nervous system disorders     
Coordination abnormal * 1  0/25 (0.00%)  1/50 (2.00%) 
Dysaesthesia * 1  3/25 (12.00%)  1/50 (2.00%) 
Dysgeusia * 1  2/25 (8.00%)  2/50 (4.00%) 
Memory impairment * 1  1/25 (4.00%)  0/50 (0.00%) 
Neuropathy peripheral * 1  7/25 (28.00%)  9/50 (18.00%) 
Neurotoxicity * 1  0/25 (0.00%)  3/50 (6.00%) 
Paraesthesia * 1  6/25 (24.00%)  10/50 (20.00%) 
Peripheral sensory neuropathy * 1  5/25 (20.00%)  0/50 (0.00%) 
Polyneuropathy * 1  3/25 (12.00%)  7/50 (14.00%) 
Restless legs syndrome * 1  1/25 (4.00%)  0/50 (0.00%) 
Sensory disturbance * 1  0/25 (0.00%)  2/50 (4.00%) 
Tremor * 1  0/25 (0.00%)  1/50 (2.00%) 
Psychiatric disorders     
Anxiety * 1  1/25 (4.00%)  1/50 (2.00%) 
Apathy * 1  0/25 (0.00%)  2/50 (4.00%) 
Disorientation * 1  0/25 (0.00%)  1/50 (2.00%) 
Insomnia * 1  2/25 (8.00%)  3/50 (6.00%) 
Renal and urinary disorders     
Haematuria * 1  1/25 (4.00%)  0/50 (0.00%) 
Proteinuria * 1  1/25 (4.00%)  2/50 (4.00%) 
Renal pain * 1  0/25 (0.00%)  1/50 (2.00%) 
Reproductive system and breast disorders     
Breast cyst * 1  0/25 (0.00%)  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  3/25 (12.00%)  2/50 (4.00%) 
Dysphonia * 1  0/25 (0.00%)  1/50 (2.00%) 
Dyspnoea * 1  2/25 (8.00%)  3/50 (6.00%) 
Dyspnoea exertional * 1  0/25 (0.00%)  1/50 (2.00%) 
Epistaxis * 1  2/25 (8.00%)  4/50 (8.00%) 
Increased upper airway secretion * 1  0/25 (0.00%)  1/50 (2.00%) 
Oropharyngeal pain * 1  1/25 (4.00%)  1/50 (2.00%) 
Productive cough * 1  1/25 (4.00%)  0/50 (0.00%) 
Rhinorrhoea * 1  2/25 (8.00%)  1/50 (2.00%) 
Rhonchi * 1  1/25 (4.00%)  0/50 (0.00%) 
Throat irritation * 1  0/25 (0.00%)  1/50 (2.00%) 
Skin and subcutaneous tissue disorders     
Acne * 1  0/25 (0.00%)  1/50 (2.00%) 
Alopecia * 1  1/25 (4.00%)  1/50 (2.00%) 
Angioedema * 1  1/25 (4.00%)  0/50 (0.00%) 
Dermatitis allergic * 1  1/25 (4.00%)  0/50 (0.00%) 
Hyperhidrosis * 1  0/25 (0.00%)  1/50 (2.00%) 
Night sweats * 1  0/25 (0.00%)  1/50 (2.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  8/25 (32.00%)  2/50 (4.00%) 
Petechiae * 1  0/25 (0.00%)  1/50 (2.00%) 
Rash * 1  1/25 (4.00%)  2/50 (4.00%) 
Skin chapped * 1  1/25 (4.00%)  0/50 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  0/25 (0.00%)  1/50 (2.00%) 
Hypertension * 1  3/25 (12.00%)  13/50 (26.00%) 
Vascular insufficiency * 1  0/25 (0.00%)  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01077739     History of Changes
Obsolete Identifiers: NCT01069679
Other Study ID Numbers: ML22519
2009-012090-36
First Submitted: February 26, 2010
First Posted: March 1, 2010
Results First Submitted: July 15, 2014
Results First Posted: August 7, 2014
Last Update Posted: December 15, 2014