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Trial record 7 of 7 for:    amatuximab

An Efficacy Study of MORAb-009 in Subjects With 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: NCT00570713
Recruitment Status : Completed
First Posted : December 11, 2007
Results First Posted : March 27, 2012
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Morphotek

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: MORAb-009
Drug: Placebo
Drug: Gemcitabine
Enrollment 155

Recruitment Details Participants were recruited from a population of pancreatic cancer patients treated at investigational centers.
Pre-assignment Details  
Arm/Group Title MORAb-009 Plus Gemcitabine (‘MORAb-009’) Placebo Plus Gemcitabine (‘Placebo’)
Hide Arm/Group Description MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Period Title: Overall Study
Started 78 77
Completed 0 0
Not Completed 78 77
Reason Not Completed
Adverse Event             16             9
Death             7             7
Lack of Efficacy             40             49
Physician Decision             2             2
Withdrawal by Subject             3             3
Discontinuation of Study by the Sponsor             10             7
Arm/Group Title MORAb-009 Plus Gemcitabine (‘MORAb-009’) Placebo Plus Gemcitabine (‘Placebo’) Total
Hide Arm/Group Description MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. Total of all reporting groups
Overall Number of Baseline Participants 78 77 155
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 77 participants 155 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
78
 100.0%
77
 100.0%
155
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 77 participants 155 participants
64.3  (12.7) 65.8  (10.3) 65.0  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 77 participants 155 participants
Female
39
  50.0%
38
  49.4%
77
  49.7%
Male
39
  50.0%
39
  50.6%
78
  50.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 77 participants 155 participants
African American 2 2 4
Asian 0 3 3
Hispanic 6 4 10
White - White/Caucasian/European Heritage 69 67 136
Other 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 77 participants 155 participants
North America 57 57 114
Europe 21 20 41
1.Primary Outcome
Title Overall Survival (OS)
Hide Description This measure was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. The primary endpoint was analyzed when 110 events (deaths) were observed. In the absence of death confirmation or for subjects alive at the time of analysis, the survival time will be censored at the date of the last study follow-up.
Time Frame 1-21 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MORAb-009 Plus Gemcitabine ('MORAb-009') Placebo Plus Gemcitabine ('Placebo')
Hide Arm/Group Description:
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Overall Number of Participants Analyzed 78 77
Median (95% Confidence Interval)
Unit of Measure: Months
6.5
(4.5 to 8.10)
6.9
(5.4 to 8.8)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free Survival (PFS) is defined as the time from the date of randomization to the date of the first observation of disease progression (clinical or radiological) or death due to any cause. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline. If progression or death is not observed, the PFS time will be censored at the date of the last tumor assessment without evidence of progression prior to the date of initiation of further anticancer treatment.
Time Frame 1-21 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MORAb-009 Plus Gemcitabine ('MORAb-009') Placebo Plus Gemcitabine ('Placebo')
Hide Arm/Group Description:
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Overall Number of Participants Analyzed 78 77
Median (95% Confidence Interval)
Unit of Measure: Months
3.4
(1.9 to 4.7)
3.5
(2.8 to 4.9)
3.Secondary Outcome
Title Best Overall Response Rate
Hide Description Best overall response is the number of participants with a Complete Response (CR) or Partial Response (PR), as classified by independent blinded review of the CT or MRI images, based on RECIST 1.0. A CR is the disappearance of all target lesions. PR is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum longest diameter. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameters of target lesions or the appearance of one or more new lesions. Stable disease (SD) is neither CR, PR or PD.
Time Frame Baseline to response up to 21 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MORAb-009 Plus Gemcitabine ('MORAb-009') Placebo Plus Gemcitabine ('Placebo')
Hide Arm/Group Description:
MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
Overall Number of Participants Analyzed 78 77
Measure Type: Number
Unit of Measure: percentage of participants
Complete or Partial Response 6.4 7.8
Complete Response 0 0
Partial Response 6.4 7.8
Stable Disease 47.4 55.8
Progressive Disease 19.2 23.4
Not Evaluable 26.9 13.0
Time Frame From Baseline up to 21 months.
Adverse Event Reporting Description 73 participants received MORAB-009 plus gemcitabine and 75 participants received Placebo plus gemcitabine.
 
Arm/Group Title MORAb-009 Plus Gemcitabine (‘MORAb-009’) Placebo Plus Gemcitabine (‘Placebo’)
Hide Arm/Group Description MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment. Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
All-Cause Mortality
MORAb-009 Plus Gemcitabine (‘MORAb-009’) Placebo Plus Gemcitabine (‘Placebo’)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MORAb-009 Plus Gemcitabine (‘MORAb-009’) Placebo Plus Gemcitabine (‘Placebo’)
Affected / at Risk (%) Affected / at Risk (%)
Total   49/73 (67.12%)   54/75 (72.00%) 
Blood and lymphatic system disorders     
Anaemia  1  3/73 (4.11%)  5/75 (6.67%) 
Neutropenia  1  4/73 (5.48%)  3/75 (4.00%) 
Thrombocytopenia  1  3/73 (4.11%)  3/75 (4.00%) 
Bone marrow failure  1  1/73 (1.37%)  0/75 (0.00%) 
Coagulopathy  1  0/73 (0.00%)  1/75 (1.33%) 
Febrile neutropenia  1  1/73 (1.37%)  0/75 (0.00%) 
Haemolytic uraemic syndrome  1  0/73 (0.00%)  1/75 (1.33%) 
Leukopenia  1  1/73 (1.37%)  0/75 (0.00%) 
Cardiac disorders     
Cardiac arrest  1  0/73 (0.00%)  2/75 (2.67%) 
Cardio-respiratory arrest  1  0/73 (0.00%)  2/75 (2.67%) 
Gastrointestinal disorders     
Vomiting  1  6/73 (8.22%)  6/75 (8.00%) 
Nausea  1  4/73 (5.48%)  3/75 (4.00%) 
Abdominal Pain  1  3/73 (4.11%)  3/75 (4.00%) 
Obstruction gastric  1  2/73 (2.74%)  3/75 (4.00%) 
Constipation  1  1/73 (1.37%)  1/75 (1.33%) 
Gastrointestinal haemorrhage  1  2/73 (2.74%)  0/75 (0.00%) 
Ileus  1  2/73 (2.74%)  0/75 (0.00%) 
Abdominal pain upper  1  0/73 (0.00%)  1/75 (1.33%) 
Colitis  1  0/73 (0.00%)  1/75 (1.33%) 
Diarrhoea  1  0/73 (0.00%)  1/75 (1.33%) 
Duodenal perforation  1  1/73 (1.37%)  0/75 (0.00%) 
Duodenal ulcer  1  1/73 (1.37%)  0/75 (0.00%) 
Duodenal ulcer haemorrhage  1  1/73 (1.37%)  0/75 (0.00%) 
Faecaloma  1  0/73 (0.00%)  1/75 (1.33%) 
Gastrointestinal motility disorder  1  1/73 (1.37%)  0/75 (0.00%) 
Intestinal obstruction  1  1/73 (1.37%)  0/75 (0.00%) 
Oesophageal perforation  1  1/73 (1.37%)  0/75 (0.00%) 
Pancreatitis  1  0/73 (0.00%)  1/75 (1.33%) 
Pneumoperitoneum  1  0/73 (0.00%)  1/75 (1.33%) 
Small intestinal obstruction  1  0/73 (0.00%)  1/75 (1.33%) 
General disorders     
Asthenia  1  4/73 (5.48%)  1/75 (1.33%) 
General physical health deterioration  1  1/73 (1.37%)  4/75 (5.33%) 
Pyrexia  1  2/73 (2.74%)  3/75 (4.00%) 
Chest pain  1  0/73 (0.00%)  2/75 (2.67%) 
Generalized oedema  1  1/73 (1.37%)  1/75 (1.33%) 
Chills  1  1/73 (1.37%)  0/75 (0.00%) 
Multi-organ failure  1  1/73 (1.37%)  0/75 (0.00%) 
Performance status decreased  1  1/73 (1.37%)  0/75 (0.00%) 
Hepatobiliary disorders     
Cholangitis  1  2/73 (2.74%)  3/75 (4.00%) 
Hyperbilirubinaemia  1  1/73 (1.37%)  3/75 (4.00%) 
Jaundice cholestatic  1  2/73 (2.74%)  2/75 (2.67%) 
Bile duct obstruction  1  1/73 (1.37%)  1/75 (1.33%) 
Hepatic failure  1  1/73 (1.37%)  1/75 (1.33%) 
Bile duct stenosis  1  0/73 (0.00%)  1/75 (1.33%) 
Bile duct stone  1  0/73 (0.00%)  1/75 (1.33%) 
Cholecystitis  1  0/73 (0.00%)  1/75 (1.33%) 
Cholestasis  1  1/73 (1.37%)  0/75 (0.00%) 
Hepatorenal syndrome  1  1/73 (1.37%)  0/75 (0.00%) 
Jaundice  1  1/73 (1.37%)  0/75 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  0/73 (0.00%)  1/75 (1.33%) 
Hypersensitivity  1  1/73 (1.37%)  0/75 (0.00%) 
Infections and infestations     
Pneumonia  1  2/73 (2.74%)  4/75 (5.33%) 
Cellulitis  1  1/73 (1.37%)  4/75 (5.33%) 
Bacteremia  1  0/73 (0.00%)  4/75 (5.33%) 
Sepsis  1  2/73 (2.74%)  1/75 (1.33%) 
Abdominal Abscess  1  0/73 (0.00%)  1/75 (1.33%) 
Biliary Sepsis  1  1/73 (1.37%)  0/75 (0.00%) 
Catheter related infection  1  0/73 (0.00%)  1/75 (1.33%) 
Clostridium difficile colitis  1  0/73 (0.00%)  1/75 (1.33%) 
Gastroenteritis  1  0/73 (0.00%)  1/75 (1.33%) 
Herpes zoster  1  0/73 (0.00%)  1/75 (1.33%) 
Lobar pneumonia  1  0/73 (0.00%)  1/75 (1.33%) 
Septic shock  1  0/73 (0.00%)  1/75 (1.33%) 
Staphylococcal sepsis  1  1/73 (1.37%)  0/75 (0.00%) 
Urinary tract infection  1  0/73 (0.00%)  1/75 (1.33%) 
Viral infection  1  0/73 (0.00%)  1/75 (1.33%) 
Injury, poisoning and procedural complications     
Fall  1  0/73 (0.00%)  1/75 (1.33%) 
Radiation pneumonitis  1  0/73 (0.00%)  1/75 (1.33%) 
Spinal fracture  1  0/73 (0.00%)  1/75 (1.33%) 
Investigations     
Blood bilirubin increased  1  0/73 (0.00%)  1/75 (1.33%) 
International normalized ratio increased  1  1/73 (1.37%)  0/75 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  5/73 (6.85%)  7/75 (9.33%) 
Hyperglycaemia  1  1/73 (1.37%)  1/75 (1.33%) 
Hyponatraemia  1  0/73 (0.00%)  2/75 (2.67%) 
Anorexia  1  0/73 (0.00%)  1/75 (1.33%) 
Diabetes mellitus  1  1/73 (1.37%)  0/75 (0.00%) 
Hypoalbuminaemia  1  0/73 (0.00%)  1/75 (1.33%) 
Hypovolaemia  1  1/73 (1.37%)  0/75 (0.00%) 
Lactic acidosis  1  0/73 (0.00%)  1/75 (1.33%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/73 (1.37%)  0/75 (0.00%) 
Musculoskeletal discomfort  1  0/73 (0.00%)  1/75 (1.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  13/73 (17.81%)  11/75 (14.67%) 
Cancer pain  1  1/73 (1.37%)  0/75 (0.00%) 
Pancreatic carcinoma  1  1/73 (1.37%)  0/75 (0.00%) 
Pancreatic carcinoma metastatic  1  0/73 (0.00%)  1/75 (1.33%) 
Nervous system disorders     
Cerebral infarction  1  1/73 (1.37%)  0/75 (0.00%) 
Convulsion  1  1/73 (1.37%)  0/75 (0.00%) 
Ischaemic stroke  1  1/73 (1.37%)  0/75 (0.00%) 
Loss of consciousness  1  0/73 (0.00%)  1/75 (1.33%) 
Transient ischaemic attack  1  1/73 (1.37%)  0/75 (0.00%) 
Tremor  1  1/73 (1.37%)  0/75 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/73 (1.37%)  0/75 (0.00%) 
Mental status changes  1  1/73 (1.37%)  0/75 (0.00%) 
Renal and urinary disorders     
Renal failure  1  1/73 (1.37%)  1/75 (1.33%) 
Renal failure acute  1  1/73 (1.37%)  1/75 (1.33%) 
Nephritis  1  0/73 (0.00%)  1/75 (1.33%) 
Renal disorder  1  0/73 (0.00%)  1/75 (1.33%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  7/73 (9.59%)  6/75 (8.00%) 
Dyspnoea  1  2/73 (2.74%)  1/75 (1.33%) 
Hypoxia  1  1/73 (1.37%)  0/75 (0.00%) 
Interstitial lung disease  1  0/73 (0.00%)  1/75 (1.33%) 
Pleural effusion  1  1/73 (1.37%)  0/75 (0.00%) 
Pneumonia aspiration  1  0/73 (0.00%)  1/75 (1.33%) 
Pulmonary hypertension  1  0/73 (0.00%)  1/75 (1.33%) 
Respiratory failure  1  0/73 (0.00%)  1/75 (1.33%) 
Surgical and medical procedures     
Parenteral nutrition  1  1/73 (1.37%)  0/75 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/73 (1.37%)  7/75 (9.33%) 
Arterial thrombosis limb  1  0/73 (0.00%)  1/75 (1.33%) 
Hypovolaemic shock  1  0/73 (0.00%)  1/75 (1.33%) 
Peripheral ischaemia  1  0/73 (0.00%)  1/75 (1.33%) 
Poor venous access  1  1/73 (1.37%)  0/75 (0.00%) 
Thromboangiitis obliterans  1  1/73 (1.37%)  0/75 (0.00%) 
Venous thrombosis  1  1/73 (1.37%)  0/75 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MORAb-009 Plus Gemcitabine (‘MORAb-009’) Placebo Plus Gemcitabine (‘Placebo’)
Affected / at Risk (%) Affected / at Risk (%)
Total   73/73 (100.00%)   75/75 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  32/73 (43.84%)  36/75 (48.00%) 
Thrombocytopenia  1  25/73 (34.25%)  25/75 (33.33%) 
Neutropenia  1  16/73 (21.92%)  20/75 (26.67%) 
Leukopenia  1  11/73 (15.07%)  16/75 (21.33%) 
Cardiac disorders     
Palpitations  1  4/73 (5.48%)  2/75 (2.67%) 
Tachycardia  1  1/73 (1.37%)  4/75 (5.33%) 
Gastrointestinal disorders     
Nausea  1  35/73 (47.95%)  38/75 (50.67%) 
Constipation  1  34/73 (46.58%)  27/75 (36.00%) 
Abdominal pain  1  27/73 (36.99%)  20/75 (26.67%) 
Vomiting  1  23/73 (31.51%)  24/75 (32.00%) 
Diarrhoea  1  22/73 (30.14%)  23/75 (30.67%) 
Abdominal distention  1  12/73 (16.44%)  10/75 (13.33%) 
Abdominal pain upper  1  3/73 (4.11%)  11/75 (14.67%) 
Ascites  1  8/73 (10.96%)  5/75 (6.67%) 
Flatulence  1  9/73 (12.33%)  4/75 (5.33%) 
Dyspepsia  1  7/73 (9.59%)  2/75 (2.67%) 
Stomatitis  1  3/73 (4.11%)  5/75 (6.67%) 
General disorders     
Fatigue  1  32/73 (43.84%)  32/75 (42.67%) 
Oedema peripheral  1  27/73 (36.99%)  23/75 (30.67%) 
Pyrexia  1  13/73 (17.81%)  26/75 (34.67%) 
Asthenia  1  15/73 (20.55%)  18/75 (24.00%) 
Chills  1  13/73 (17.81%)  14/75 (18.67%) 
Oedema  1  6/73 (8.22%)  4/75 (5.33%) 
Pain  1  2/73 (2.74%)  7/75 (9.33%) 
Chest pain  1  4/73 (5.48%)  3/75 (4.00%) 
General physical health deterioration  1  2/73 (2.74%)  4/75 (5.33%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  5/73 (6.85%)  8/75 (10.67%) 
Cholangitis  1  2/73 (2.74%)  4/75 (5.33%) 
Jaundice  1  2/73 (2.74%)  4/75 (5.33%) 
Infections and infestations     
Urinary tract infection  1  12/73 (16.44%)  10/75 (13.33%) 
Cellulitis  1  5/73 (6.85%)  8/75 (10.67%) 
Pneumonia  1  4/73 (5.48%)  5/75 (6.67%) 
Candidiasis  1  3/73 (4.11%)  4/75 (5.33%) 
Rhinitis  1  2/73 (2.74%)  4/75 (5.33%) 
Bacteraemia  1  1/73 (1.37%)  4/75 (5.33%) 
Investigations     
Weight decreased  1  10/73 (13.70%)  9/75 (12.00%) 
Blood alkaline Phosphatase increased  1  9/73 (12.33%)  8/75 (10.67%) 
Alanine aminotransferase increased  1  8/73 (10.96%)  6/75 (8.00%) 
Aspartate aminotransferase increased  1  8/73 (10.96%)  5/75 (6.67%) 
Neutrophil count decreased  1  5/73 (6.85%)  6/75 (8.00%) 
Haemoglobin decreased  1  7/73 (9.59%)  3/75 (4.00%) 
Blood bilirubin increased  1  4/73 (5.48%)  5/75 (6.67%) 
Platelet count decreased  1  3/73 (4.11%)  6/75 (8.00%) 
International normalised ratio increased  1  6/73 (8.22%)  2/75 (2.67%) 
Metabolism and nutrition disorders     
Anorexia  1  26/73 (35.62%)  25/75 (33.33%) 
Dehydration  1  13/73 (17.81%)  15/75 (20.00%) 
Hypokalemia  1  12/73 (16.44%)  13/75 (17.33%) 
Hyponatremia  1  7/73 (9.59%)  6/75 (8.00%) 
Decreased appetite  1  3/73 (4.11%)  7/75 (9.33%) 
Hypoalbuminaemia  1  3/73 (4.11%)  6/75 (8.00%) 
Hyperglycaemia  1  6/73 (8.22%)  2/75 (2.67%) 
Hypomagnesaemia  1  6/73 (8.22%)  2/75 (2.67%) 
Hyperkalaemia  1  5/73 (6.85%)  2/75 (2.67%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  10/73 (13.70%)  14/75 (18.67%) 
Pain in extremity  1  5/73 (6.85%)  11/75 (14.67%) 
Musculoskeletal chest pain  1  4/73 (5.48%)  5/75 (6.67%) 
Flank pain  1  4/73 (5.48%)  2/75 (2.67%) 
Myalgia  1  0/73 (0.00%)  4/75 (5.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  13/73 (17.81%)  11/75 (14.67%) 
Nervous system disorders     
Dizziness  1  12/73 (16.44%)  12/75 (16.00%) 
Headache  1  7/73 (9.59%)  9/75 (12.00%) 
Dysgeusia  1  6/73 (8.22%)  5/75 (6.67%) 
Hypoaesthesia  1  0/73 (0.00%)  5/75 (6.67%) 
Psychiatric disorders     
Insomnia  1  13/73 (17.81%)  10/75 (13.33%) 
Anxiety  1  8/73 (10.96%)  6/75 (8.00%) 
Depression  1  4/73 (5.48%)  5/75 (6.67%) 
Sleep disorder  1  2/73 (2.74%)  5/75 (6.67%) 
Confusional state  1  5/73 (6.85%)  1/75 (1.33%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  18/73 (24.66%)  11/75 (14.67%) 
Cough  1  7/73 (9.59%)  9/75 (12.00%) 
Pulmonary embolism  1  7/73 (9.59%)  8/75 (10.67%) 
Dyspnoea exertional  1  4/73 (5.48%)  5/75 (6.67%) 
Pleural effusion  1  4/73 (5.48%)  3/75 (4.00%) 
Productive cough  1  5/73 (6.85%)  0/75 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  11/73 (15.07%)  16/75 (21.33%) 
Alopecia  1  11/73 (15.07%)  6/75 (8.00%) 
Night sweats  1  6/73 (8.22%)  5/75 (6.67%) 
Pruritus  1  4/73 (5.48%)  6/75 (8.00%) 
Vascular disorders     
Deep vein thrombosis  1  7/73 (9.59%)  11/75 (14.67%) 
Hypertension  1  5/73 (6.85%)  10/75 (13.33%) 
Hypotension  1  5/73 (6.85%)  6/75 (8.00%) 
Pallor  1  4/73 (5.48%)  0/75 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
Results Point of Contact
Name/Title: Susan Weil, MD
Organization: Morphotek, Inc.
Phone: 610-423-6182
Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00570713     History of Changes
Other Study ID Numbers: MORAb-009-002
First Submitted: December 7, 2007
First Posted: December 11, 2007
Results First Submitted: December 8, 2011
Results First Posted: March 27, 2012
Last Update Posted: September 9, 2015