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Study of Vandetanib Combined With Chemotherapy to Treat Advanced Non-small Cell Lung 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: NCT00687297
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : July 10, 2012
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
PrECOG, LLC.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Lung Cancer
Non Small Cell Lung Cancer
Interventions Drug: vandetanib induction
Drug: Docetaxel
Drug: Carboplatin
Drug: Placebo
Drug: Vandetanib maintenance
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Randomized to Vandetanib Maintenance Randomized to Placebo Maintenance
Hide Arm/Group Description Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days] Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
Period Title: Randomization
Started 80 82
Completed 77 81
Not Completed 3 1
Reason Not Completed
Withdrawal by Subject             2             0
Withdrew before treatment, ineligible             1             1
Period Title: Induction
Started 77 81
Completed 32 26
Not Completed 45 55
Reason Not Completed
Withdrawal by Subject             4             4
Adverse Event             16             15
Death             7             11
Lack of Efficacy             17             21
Ineligible             0             1
Patient Noncompliance             1             0
Physician Decision             0             2
Other             0             1
Period Title: Maintenance
Started 32 26
Completed 29 25
Not Completed 3 1
Arm/Group Title Randomized to Vandetanib Maintenance Randomized to Placebo Maintenance Total
Hide Arm/Group Description Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days] Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days] Total of all reporting groups
Overall Number of Baseline Participants 80 82 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 80 participants 82 participants 162 participants
63.5
(38 to 84)
63
(36 to 82)
63
(36 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 82 participants 162 participants
Female
38
  47.5%
40
  48.8%
78
  48.1%
Male
42
  52.5%
42
  51.2%
84
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 80 participants 82 participants 162 participants
80 82 162
1.Primary Outcome
Title Progression-free Survival
Hide Description Time from randomization (prior to induction) to first evidence of disease progression or death without progression. Participants alive without progression were censored at the date of last disease evaluation.
Time Frame Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were included.
Arm/Group Title All Randomized Patients
Hide Arm/Group Description:
All patients enrolled in the study
Overall Number of Participants Analyzed 162
Median (95% Confidence Interval)
Unit of Measure: Months
4.5
(3.6 to 4.9)
2.Secondary Outcome
Title Objective Response Rate
Hide Description Best overall response (complete or partial response), assessed using RECIST criteria (version 1.0)
Time Frame Assessed every 2 cycles (1 cycle = 3 weeks during induction and 4 weeks during maintenance))
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were included.
Arm/Group Title Randomized to Vandetanib Maintenance Randomized to Placebo Maintenance
Hide Arm/Group Description:
Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
Overall Number of Participants Analyzed 82 80
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.8
(10.9 to 29.0)
18.3
(10.6 to 28.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized to Vandetanib Maintenance, Randomized to Placebo Maintenance
Comments Fisher's exact test with two-sided Type I error of 5% was used to test the null hypothesis of no difference in response rate between arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-free Survival
Hide Description Time from randomization to first evidence of disease progression or death. Patients alive without progression are censored at the date of last disease evaluation.
Time Frame every 2 cycles (every 6 weeks during induction, every 8 weeks during maintenance)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients were included.
Arm/Group Title Randomized to Vandetanib Maintenance Randomized to Placebo Maintenance
Hide Arm/Group Description:
Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: vandetanib (300mg) daily until progression [1 Cycle= 28 days]
Docetaxel (75mg/m2)IV (in the vein) + Carboplatin IV (AUC=6) day 1 of 21 day cycle + vandetanib (100mg) days 1 through 21 (daily) x 4 cycles. If SD, PR CR after 4 cycles --> Maintenance treatment: Placebo 3 tablets daily until progression [1 Cycle= 28 days]
Overall Number of Participants Analyzed 80 82
Median (95% Confidence Interval)
Unit of Measure: months
4.5
(3.3 to 5.8)
4.2
(2.8 to 4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized to Vandetanib Maintenance, Randomized to Placebo Maintenance
Comments There was 80% power to detect a 50% improvement in median progression-free survival, using a stratified log-rank test with one-sided Type I error of 10%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments p-value from Wald test
Method Regression, Cox
Comments The model was adjusted for gender (male vs. female) and stage (Stage IIIB vs. Stage IV/Recurrent)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
1.07 to 2.07
Estimation Comments [Not Specified]
Time Frame Adverse events were assessed every 3 weeks during induction and every 4 weeks during maintenance.
Adverse Event Reporting Description Serious adverse events are defined as events of grade 3 or higher that were considered possibly, probably, or definitely treatment-related. Other adverse events include grade 1 or 2 events possibly, probably or definitely treatment-related occurring at a rate of 5% or higher.
 
Arm/Group Title Treated on Vandetanib Maintenance Treated on Placebo Maintenance All Treated Patients - Induction
Hide Arm/Group Description Adverse events among patients receiving Vandetanib using the maintenance phase of the study Adverse events among patients receiving placebo during the maintenance phase of the study Adverse events occurring during induction among all treated patients
All-Cause Mortality
Treated on Vandetanib Maintenance Treated on Placebo Maintenance All Treated Patients - Induction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treated on Vandetanib Maintenance Treated on Placebo Maintenance All Treated Patients - Induction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/32 (68.75%)   11/26 (42.31%)   111/157 (70.70%) 
Blood and lymphatic system disorders       
Febrile Neutropenia  1  0/32 (0.00%)  0/26 (0.00%)  10/157 (6.37%) 
Anemia  1  0/32 (0.00%)  2/26 (7.69%)  4/157 (2.55%) 
Leukocytes increased  1  0/32 (0.00%)  0/26 (0.00%)  25/157 (15.92%) 
Cardiac disorders       
Atrial fibrillation  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Cardiac - other  1  1/32 (3.13%)  0/26 (0.00%)  1/157 (0.64%) 
Eye disorders       
Photosensitivity  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Gastrointestinal disorders       
Anorexia  1  0/32 (0.00%)  0/26 (0.00%)  3/157 (1.91%) 
Colitis, infectious  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Diarrhea w/o Prior Colostomy  1  3/32 (9.38%)  0/26 (0.00%)  14/157 (8.92%) 
Muco/stomatitis by exam, oral cavity  1  0/32 (0.00%)  0/26 (0.00%)  2/157 (1.27%) 
Nausea  1  0/32 (0.00%)  1/26 (3.85%)  2/157 (1.27%) 
Perforation, colon  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Upper GI hemorrhage, NOS  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Vomiting  1  0/32 (0.00%)  1/26 (3.85%)  1/157 (0.64%) 
Abdomen, pain  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
Cholecystitis  1  1/32 (3.13%)  1/26 (3.85%)  0/157 (0.00%) 
Constipation  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
Dental/teeth/periodontal pain  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
GI - other  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
General disorders       
Death NOS  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Fatigue  1  2/32 (6.25%)  1/26 (3.85%)  12/157 (7.64%) 
Insomnia  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Death, disease progression NOS  1  2/32 (6.25%)  0/26 (0.00%)  0/157 (0.00%) 
Immune system disorders       
Allergic Reaction  1  0/32 (0.00%)  0/26 (0.00%)  3/157 (1.91%) 
Infections and infestations       
Infection w grade 3-4 neutrophils, lung  1  0/32 (0.00%)  0/26 (0.00%)  3/157 (1.91%) 
Infection w/unk ANC, abdomen NOS  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Infection w/unk ANC, liver  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Infection w/unk ANC, lung  1  0/32 (0.00%)  1/26 (3.85%)  2/157 (1.27%) 
Infection - other  1  0/32 (0.00%)  0/26 (0.00%)  3/157 (1.91%) 
Infection w/gr 0-2 neutrophils, lung  1  1/32 (3.13%)  0/26 (0.00%)  0/157 (0.00%) 
Infection w/Unk ANC, stomach  1  1/32 (3.13%)  0/26 (0.00%)  0/157 (0.00%) 
Investigations       
Lymphopenia  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Neutrophil count decreased  1  1/32 (3.13%)  0/26 (0.00%)  65/157 (41.40%) 
Platelet count decreased  1  0/32 (0.00%)  0/26 (0.00%)  3/157 (1.91%) 
QTc Interval prolonged  1  1/32 (3.13%)  0/26 (0.00%)  7/157 (4.46%) 
Weight loss  1  1/32 (3.13%)  0/26 (0.00%)  1/157 (0.64%) 
AST, SGOT Increased  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
Creatinine increased  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  1/32 (3.13%)  0/26 (0.00%)  5/157 (3.18%) 
Hyperglycemia  1  1/32 (3.13%)  0/26 (0.00%)  1/157 (0.64%) 
Hypoalbuminemia  1  0/32 (0.00%)  0/26 (0.00%)  3/157 (1.91%) 
Hypocalcemia  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Hypokalemia  1  1/32 (3.13%)  0/26 (0.00%)  4/157 (2.55%) 
Hypomagnesemia  1  0/32 (0.00%)  0/26 (0.00%)  2/157 (1.27%) 
Hyponatremia  1  1/32 (3.13%)  1/26 (3.85%)  4/157 (2.55%) 
Hypophosphatemia  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Metabolic/Laboratory, other  1  0/32 (0.00%)  0/26 (0.00%)  2/157 (1.27%) 
Taste disturbance  1  1/32 (3.13%)  0/26 (0.00%)  0/157 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/32 (3.13%)  2/26 (7.69%)  1/157 (0.64%) 
Extremity - limb, pain  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Joint pain  1  1/32 (3.13%)  1/26 (3.85%)  1/157 (0.64%) 
Muscle pain  1  0/32 (0.00%)  1/26 (3.85%)  1/157 (0.64%) 
Fracture  1  1/32 (3.13%)  0/26 (0.00%)  0/157 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Secondary malignancy  1  1/32 (3.13%)  0/26 (0.00%)  0/157 (0.00%) 
Nervous system disorders       
CNS cerebrovascular ischemia  1  0/32 (0.00%)  0/26 (0.00%)  2/157 (1.27%) 
Dizziness  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Nonneuropathic generalized weakness  1  0/32 (0.00%)  0/26 (0.00%)  4/157 (2.55%) 
Syncope  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Neuropathy, motor  1  1/32 (3.13%)  0/26 (0.00%)  0/157 (0.00%) 
Seizure  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
Psychiatric disorders       
Anxiety  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Depression  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Psychosis  1  1/32 (3.13%)  0/26 (0.00%)  0/157 (0.00%) 
Renal and urinary disorders       
Renal failure  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
Reproductive system and breast disorders       
Chest/thoracic pain NOS  1  1/32 (3.13%)  2/26 (7.69%)  0/157 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  3/32 (9.38%)  1/26 (3.85%)  3/157 (1.91%) 
Hemorrhage - other  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Hypoxia  1  1/32 (3.13%)  0/26 (0.00%)  1/157 (0.64%) 
Lung hemorrhage  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Bronchospasm, wheezing  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
Cough  1  0/32 (0.00%)  1/26 (3.85%)  0/157 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry Skin  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Erythema multiforme  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Rash/desquamation  1  5/32 (15.63%)  2/26 (7.69%)  6/157 (3.82%) 
Skin - other  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Sweating  1  0/32 (0.00%)  0/26 (0.00%)  1/157 (0.64%) 
Pruritus/itching  1  3/32 (9.38%)  1/26 (3.85%)  0/157 (0.00%) 
Rash: acne/acneiform  1  1/32 (3.13%)  0/26 (0.00%)  0/157 (0.00%) 
Vascular disorders       
Hypertension  1  2/32 (6.25%)  0/26 (0.00%)  3/157 (1.91%) 
Thrombosis/thrombus/embolism  1  0/32 (0.00%)  1/26 (3.85%)  9/157 (5.73%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE Version 3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treated on Vandetanib Maintenance Treated on Placebo Maintenance All Treated Patients - Induction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/32 (90.63%)   22/26 (84.62%)   145/157 (92.36%) 
Blood and lymphatic system disorders       
Anemia  1  3/32 (9.38%)  1/26 (3.85%)  23/157 (14.65%) 
Leukopenia  1  2/32 (6.25%)  0/26 (0.00%)  9/157 (5.73%) 
Gastrointestinal disorders       
Abdomen, Pain  1  3/32 (9.38%)  0/26 (0.00%)  7/157 (4.46%) 
Constipation  1  1/32 (3.13%)  1/26 (3.85%)  17/157 (10.83%) 
Diarrhea w/o prior colostomy  1  15/32 (46.88%)  3/26 (11.54%)  44/157 (28.03%) 
Dry Mouth  1  3/32 (9.38%)  0/26 (0.00%)  0/157 (0.00%) 
Dyspepsia  1  2/32 (6.25%)  1/26 (3.85%)  11/157 (7.01%) 
Dysphagia  1  2/32 (6.25%)  1/26 (3.85%)  4/157 (2.55%) 
Muco/stomatitis by exam, oral cavity  1  3/32 (9.38%)  1/26 (3.85%)  27/157 (17.20%) 
Nausea  1  7/32 (21.88%)  4/26 (15.38%)  50/157 (31.85%) 
Vomiting  1  3/32 (9.38%)  0/26 (0.00%)  22/157 (14.01%) 
General disorders       
Edema, head and neck  1  2/32 (6.25%)  1/26 (3.85%)  1/157 (0.64%) 
Edema, limb  1  2/32 (6.25%)  0/26 (0.00%)  9/157 (5.73%) 
Fatigue  1  10/32 (31.25%)  10/26 (38.46%)  53/157 (33.76%) 
Rigors/chills  1  2/32 (6.25%)  1/26 (3.85%)  2/157 (1.27%) 
Investigations       
Creatinine increased  1  3/32 (9.38%)  0/26 (0.00%)  6/157 (3.82%) 
Platelet count decreased  1  0/32 (0.00%)  0/26 (0.00%)  12/157 (7.64%) 
Weight loss  1  2/32 (6.25%)  0/26 (0.00%)  9/157 (5.73%) 
Metabolism and nutrition disorders       
Anorexia  1  6/32 (18.75%)  3/26 (11.54%)  27/157 (17.20%) 
Hyperglycemia  1  1/32 (3.13%)  3/26 (11.54%)  5/157 (3.18%) 
Hypokalemia  1  2/32 (6.25%)  0/26 (0.00%)  2/157 (1.27%) 
Hypomagnesemia  1  3/32 (9.38%)  0/26 (0.00%)  13/157 (8.28%) 
Musculoskeletal and connective tissue disorders       
Back, pain  1  0/32 (0.00%)  2/26 (7.69%)  5/157 (3.18%) 
Joint pain  1  2/32 (6.25%)  0/26 (0.00%)  6/157 (3.82%) 
Nervous system disorders       
Dizziness  1  3/32 (9.38%)  1/26 (3.85%)  5/157 (3.18%) 
Neuropathy, sensory  1  5/32 (15.63%)  3/26 (11.54%)  22/157 (14.01%) 
Taste disturbance  1  2/32 (6.25%)  0/26 (0.00%)  14/157 (8.92%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/32 (6.25%)  3/26 (11.54%)  6/157 (3.82%) 
Dyspnea  1  3/32 (9.38%)  3/26 (11.54%)  5/157 (3.18%) 
Nose, hemorrhage  1  2/32 (6.25%)  0/26 (0.00%)  9/157 (5.73%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  8/32 (25.00%)  4/26 (15.38%)  50/157 (31.85%) 
Dry Skin  1  4/32 (12.50%)  4/26 (15.38%)  5/157 (3.18%) 
Nail changes  1  2/32 (6.25%)  4/26 (15.38%)  6/157 (3.82%) 
Photosensitivity  1  3/32 (9.38%)  0/26 (0.00%)  1/157 (0.64%) 
Pruritus/itching  1  4/32 (12.50%)  2/26 (7.69%)  6/157 (3.82%) 
Rash/desquamation  1  11/32 (34.38%)  5/26 (19.23%)  25/157 (15.92%) 
Rash: acne/acneiform  1  6/32 (18.75%)  1/26 (3.85%)  4/157 (2.55%) 
Vascular disorders       
Hypertension  1  2/32 (6.25%)  2/26 (7.69%)  7/157 (4.46%) 
Thrombosis/thrombus/embolism  1  1/32 (3.13%)  0/26 (0.00%)  8/157 (5.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE Version 3
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: Study Statistician
Organization: PrECOG
Phone: 617-632-3633
Responsible Party: PrECOG, LLC.
ClinicalTrials.gov Identifier: NCT00687297     History of Changes
Other Study ID Numbers: PrE0501
IRUSZACT0088 ( Other Identifier: AstraZeneca )
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: June 6, 2012
Results First Posted: July 10, 2012
Last Update Posted: May 30, 2018