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Efficacy and Safety of Immuncell-LC Group and Non-treatment Group in Hepatocelluar Carcinoma Patients

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: NCT00699816
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : September 24, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
GC Cell Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatocellular Carcinoma
Intervention Biological: Immuncell-LC
Enrollment 230
Recruitment Details This phase 3 clinical study was a multicenter, randomized, open-labeled trial. The study was conducted at 5 university affiliated hospitals in Korea. All eligible participants were assigned randomly, in a 1:1 ratio, to receive adjuvant adoptive immune therapy using a CIK cell agent or no adjuvant treatment.
Pre-assignment Details  
Arm/Group Title Immunotherapy Group Control Group
Hide Arm/Group Description Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Period Title: Overall Study
Started 115 115
Completed 114 112
Not Completed 1 3
Reason Not Completed
Protocol Violation             1             3
Arm/Group Title Immunotherapy Group Control Group Total
Hide Arm/Group Description Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment Total of all reporting groups
Overall Number of Baseline Participants 114 112 226
Hide Baseline Analysis Population Description
A total of 230 eligible participants were assigned randomly to either the immunotherapy group(n=115) or the control group(n=115). Among these randomized patients, 226(114 in the immunotherapy group and 112 in the control group) were included in the efficacy analysis. 4 patients were excluded due to violation of the inclusion and exclusion criteria.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 114 participants 112 participants 226 participants
55.4  (8.2) 56.4  (10.6) 55.9  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 112 participants 226 participants
Female
19
  16.7%
21
  18.8%
40
  17.7%
Male
95
  83.3%
91
  81.3%
186
  82.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 114 participants 112 participants 226 participants
114 112 226
Treatment modality  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 112 participants 226 participants
Percutaneous ethanol injection 13 4 17
Radiofrequency ablation 69 70 139
Surgical resection 32 38 70
HCC stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 112 participants 226 participants
Stage I 98 94 192
Stage II 16 18 34
[1]
Measure Description:

HCC staging criteria is AJCC staging system(6th edition) developed by the American Joint Committee on Cancer for describing the extent of disease progression in cancer patients. It utilizes in part the TNM scoring system: Tumor size, Lymph Nodes affected, Metastases.

The TNM Staging System is based on the extent of the tumor (T), the extent of spread to the lymph nodes (N), and the presence of metastasis (M). Once the T, N, and M are determined, they are combined, and an overall "Stage" of I, II, III, IV is assigned. Higher stage cancers are more advanced.

Number of HCC   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 112 participants 226 participants
>3 or =3 2 2 4
<3 112 110 222
[1]
Measure Description: Tumor assessments were performed using dynamic computed tomography or magnetic resonance imaging. All scans were reviewed by 2 independent radiologists at each site(hospital) with more than 5 years' experience, who were unaware of the group assignment. In cases of discordance, an additional third independent experienced radiologist reviewed images and consensus was achieved among the 3 radiologists.
Size of HCC   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Centimeter
Number Analyzed 114 participants 112 participants 226 participants
1.8
(1.4 to 2.3)
2.3
(1.5 to 3.1)
2.0
(1.4 to 2.7)
[1]
Measure Description: Tumor assessments were performed using dynamic computed tomography or magnetic resonance imaging. All scans were reviewed by 2 independent radiologists at each site(hospital) with more than 5 years' experience, who were unaware of the group assignment. In cases of discordance, an additional third independent experienced radiologist reviewed images and consensus was achieved among the 3 radiologists.
ECOG performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 112 participants 226 participants
0 81 81 162
1 33 31 64
[1]
Measure Description: ECOG (Eastern Cooperative Oncology Group) performance status assesses the daily living abilities of the patient, on a scale ranging from 0(fully active) to 5(dead).
Cause of liver disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 112 participants 226 participants
HBV infection only 96 90 186
HCV infection only 9 10 19
HBV and HCV 2 2 4
Co-infection (Others) 7 10 17
Co-infection (Cirrhosis) 76 70 146
Alpha fetoprotein level  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 114 participants 112 participants 226 participants
5.2
(3.1 to 9.9)
5.4
(3.0 to 13.0)
5.3
(3 to 11.4)
PIVKA-II  
Median (Inter-Quartile Range)
Unit of measure:  mAU/mL
Number Analyzed 114 participants 112 participants 226 participants
19.0
(14.0 to 24.8)
18.0
(14.0 to 24.0)
18.5
(14 to 24.4)
Aspartate aminotransferase level  
Median (Inter-Quartile Range)
Unit of measure:  IU/L
Number Analyzed 114 participants 112 participants 226 participants
33.0
(27.0 to 43.5)
34.0
(26.8 to 44.0)
33.5
(26.9 to 43.8)
Alanine aminotransferase level  
Median (Inter-Quartile Range)
Unit of measure:  IU/L
Number Analyzed 114 participants 112 participants 226 participants
33.0
(25.0 to 45.8)
33.0
(23.0 to 47.5)
33.0
(24.0 to 46.7)
Alkaline phosphatase level  
Median (Inter-Quartile Range)
Unit of measure:  IU/L
Number Analyzed 114 participants 112 participants 226 participants
82.5
(70.0 to 101.5)
82.0
(65.0 to 100.0)
82.3
(67 to 100.3)
Albumin level  
Median (Inter-Quartile Range)
Unit of measure:  g/dL
Number Analyzed 114 participants 112 participants 226 participants
4.1
(3.9 to 4.3)
4.1
(3.9 to 4.3)
4.1
(3.9 to 4.3)
Total bilirubin level  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 114 participants 112 participants 226 participants
0.8
(0.6 to 1.0)
0.8
(0.6 to 1.0)
0.8
(0.6 to 1.0)
Prothrombin time  
Median (Inter-Quartile Range)
Unit of measure:  Seconds
Number Analyzed 114 participants 112 participants 226 participants
13.7
(13.1 to 14.7)
13.9
(13.2 to 14.4)
13.8
(13.2 to 14.6)
Creatinine level  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 114 participants 112 participants 226 participants
0.9
(0.8 to 1.0)
0.9
(0.7 to 1.0)
0.9
(0.8 to 1.0)
Platelet  
Median (Inter-Quartile Range)
Unit of measure:  X 10^3/mm^3
Number Analyzed 114 participants 112 participants 226 participants
116.5
(92.3 to 158.0)
141.0
(117.5 to 166.3)
128.6
(100.0 to 157.2)
1.Primary Outcome
Title Recurrence Free Survival(RFS)
Hide Description RFS was measured from the date of randomization to the first recurrence or to death from any cause.
Time Frame Every 3months from the baseline for 24 months and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunotherapy Group Control Group
Hide Arm/Group Description:
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed 114 112
Median (95% Confidence Interval)
Unit of Measure: months
44.0
(42.46 to 44.54)
30.0
(28.25 to 31.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunotherapy Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.43 to 0.94
Estimation Comments [Not Specified]
2.Primary Outcome
Title Recurrence Free Survival(RFS) Rate
Hide Description RFS rate was measured from the date of randomization to the first recurrence or to death from any cause.
Time Frame Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunotherapy Group Control Group
Hide Arm/Group Description:
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed 114 112
Measure Type: Number
Unit of Measure: percentage of participants
RFS rate 12 months 79.9 65.1
RFS rate 24 months 72.5 53.8
RFS rate 36 months 60.9 44.3
RFS rate 48 months 49.6 39.6
3.Secondary Outcome
Title Overall Survival(OS)
Hide Description Overall survival was measured from the date of randomization until death from any cause.
Time Frame Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunotherapy Group Control Group
Hide Arm/Group Description:
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed 114 112
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
At the time of the date cut-off date, 15 deaths had occurred in the efficacy population. Median OS was not reached.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunotherapy Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
0.06 to 0.75
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Cancer-specific Survivals
Hide Description Cancer-specific survival was measured from the date of randomization until death resulting from HCC.
Time Frame Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunotherapy Group Control Group
Hide Arm/Group Description:
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed 114 112
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
At the time of the date cut-off date, 15 deaths had occurred in the efficacy population. Median Cancer-specific survival was not reached.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunotherapy Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.04 to 0.87
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival(OS) Rate
Hide Description Overall survival rate was measured from the date of randomization until death from any cause.
Time Frame Every 3months from the baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunotherapy Group Control Group
Hide Arm/Group Description:
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed 114 112
Measure Type: Number
Unit of Measure: percentage of participants
OS rate 12 months 100.0 98.0
OS rate 24 months 100.0 91.8
OS rate 36 months 97.5 88.1
OS rate 48 months 95.9 84.8
6.Secondary Outcome
Title Cancer-specific Survival Rate
Hide Description Cancer-specific survival rate was measured from the date of randomization until death resulting from HCC.
Time Frame Every 3 months from baseline for 24 months, and then every 3-6 months until the data cut-off date, up to LSLV(Last Subject Last Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immunotherapy Group Control Group
Hide Arm/Group Description:
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent
Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
Overall Number of Participants Analyzed 114 112
Measure Type: Number
Unit of Measure: percentage of participants
Cancer-specific survival rate 12 months 100.0 98.0
Cancer-specific survival rate 24 months 100.0 94.9
Cancer-specific survival rate 36 months 98.8 91.0
Cancer-specific survival rate 48 months 97.2 87.5
Time Frame Adverse events were assessed from the time the patient provided written informed consent until the end of the study or drop-out, and until at least 30 days after the last dose of immunotherapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immunotherapy Group Control Group
Hide Arm/Group Description Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with adjuvant adoptive immune therapy using a CIK cell agent Patients who had undergone curative treatment(surgical resection, radiofrequency ablation[RFA], or percutaneous ethanol injection[PEI]) for HCC of pretreatment clinical stage I or II according to the American Joint Committee on Cancer staging system(6th edition) based on radiologic imaging studies were eligible for this study with no adjuvant treatment
All-Cause Mortality
Immunotherapy Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Immunotherapy Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/115 (7.83%)      4/115 (3.48%)    
Ear and labyrinth disorders     
Sudden hearing loss * 1  0/115 (0.00%)  0 1/115 (0.87%)  1
Gastrointestinal disorders     
Gastric ulcer * 1  0/115 (0.00%)  0 1/115 (0.87%)  1
Oesophageal varices haemorrhage * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Haemorrhoids * 1  0/115 (0.00%)  0 1/115 (0.87%)  1
Hepatobiliary disorders     
Hepatic vein stenosis * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Infections and infestations     
Herpes zoster * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Injury, poisoning and procedural complications     
Laceration * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Meniscus lesion * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Humerus fracture * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Foot fracture * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder neoplasm * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Gastric adenoma * 1  0/115 (0.00%)  0 1/115 (0.87%)  1
Surgical and medical procedures     
High frequency ablation * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immunotherapy Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/115 (61.74%)      47/115 (40.87%)    
Ear and labyrinth disorders     
Sudden hearing loss * 1  0/115 (0.00%)  0 1/115 (0.87%)  1
Gastrointestinal disorders     
Abdominal pain upper * 1  2/115 (1.74%)  2 5/115 (4.35%)  5
Nausea * 1  3/115 (2.61%)  3 1/115 (0.87%)  1
Vomiting * 1  3/115 (2.61%)  3 3/115 (2.61%)  4
Dyspepsia * 1  6/115 (5.22%)  6 4/115 (3.48%)  4
Epigastric discomfort * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Gastritis erosive * 1  1/115 (0.87%)  1 2/115 (1.74%)  2
Abdominal pain * 1  2/115 (1.74%)  4 2/115 (1.74%)  3
Gastritis * 1  0/115 (0.00%)  0 3/115 (2.61%)  3
Gastric polyps * 1  0/115 (0.00%)  0 3/115 (2.61%)  3
Gastric ulcer * 1  1/115 (0.87%)  1 2/115 (1.74%)  3
Constipation * 1  3/115 (2.61%)  4 2/115 (1.74%)  2
Haemorrhoids * 1  1/115 (0.87%)  1 3/115 (2.61%)  3
General disorders     
Chills * 1  11/115 (9.57%)  24 0/115 (0.00%)  0
Pyrexia * 1  12/115 (10.43%)  22 0/115 (0.00%)  0
Fatigue * 1  11/115 (9.57%)  12 3/115 (2.61%)  3
Asthenia * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Chest discomfort * 1  3/115 (2.61%)  3 0/115 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection * 1  6/115 (5.22%)  6 4/115 (3.48%)  5
Body tinea * 1  0/115 (0.00%)  0 1/115 (0.87%)  1
Herpes zoster * 1  2/115 (1.74%)  2 0/115 (0.00%)  0
Injury, poisoning and procedural complications     
Laceration * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Foot fracture * 1  1/115 (0.87%)  1 1/115 (0.87%)  1
Humerus fracture * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Investigations     
Alanine aminotransferase increased * 1  2/115 (1.74%)  2 1/115 (0.87%)  1
Weight decreased * 1  0/115 (0.00%)  0 3/115 (2.61%)  3
Weight increased * 1  2/115 (1.74%)  3 0/115 (0.00%)  0
Metabolism and nutrition disorders     
Hyperuricaemia * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia * 1  5/115 (4.35%)  6 0/115 (0.00%)  0
Back pain * 1  2/115 (1.74%)  3 1/115 (0.87%)  1
Flank pain * 1  3/115 (2.61%)  3 1/115 (0.87%)  1
Nervous system disorders     
Dizziness * 1  5/115 (4.35%)  5 3/115 (2.61%)  3
Headache * 1  3/115 (2.61%)  4 1/115 (0.87%)  1
Psychiatric disorders     
Insomnia * 1  1/115 (0.87%)  1 3/115 (2.61%)  3
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/115 (0.87%)  1 1/115 (0.87%)  1
Productive cough * 1  6/115 (5.22%)  6 0/115 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis acneiform * 1  0/115 (0.00%)  0 2/115 (1.74%)  2
Pruritus * 1  5/115 (4.35%)  5 4/115 (3.48%)  4
Dermatitis * 1  1/115 (0.87%)  1 0/115 (0.00%)  0
Vascular disorders     
Hypertension * 1  2/115 (1.74%)  2 2/115 (1.74%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Layout table for Results Point of Contact information
Name/Title: Jung-Hwan Yoon, MD, PhD
Organization: Seoul National University College of Medicine
Phone: +82-2-2072-2228
EMail: yoonjh@snu.ac.kr
Layout table for additonal information
Responsible Party: GC Cell Corporation
ClinicalTrials.gov Identifier: NCT00699816    
Other Study ID Numbers: IIC-I01
First Submitted: June 17, 2008
First Posted: June 18, 2008
Results First Submitted: June 18, 2015
Results First Posted: September 24, 2015
Last Update Posted: October 26, 2017