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BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC

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: NCT00410189
Recruitment Status : Completed
First Posted : December 12, 2006
Results First Posted : March 23, 2015
Last Update Posted : March 23, 2015
Sponsor:
Collaborators:
United States Department of Defense
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Intervention Drug: ZD6474
Enrollment 54
Recruitment Details Recruitment period: November 2006 to February 2010. All participants recruited at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title ZD6474
Hide Arm/Group Description ZD6474 300 mg by mouth daily.
Period Title: Overall Study
Started 54
Completed 54
Not Completed 0
Arm/Group Title ZD6474
Hide Arm/Group Description ZD6474 300 mg by mouth daily.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 54 participants
61
(34 to 80)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 54 participants
<=50 years 11
Between 51 and 60 years 15
Between 61 and 70 years 19
>70 years 9
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
29
  53.7%
Male
25
  46.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants
54
1.Primary Outcome
Title 8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease)
Hide Description The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.
Time Frame Baseline to 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474
Hide Arm/Group Description:
ZD6474 300 mg by mouth daily.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
33
2.Secondary Outcome
Title 8 Week Progression-Free Survival
Hide Description Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.
Time Frame Every 8 weeks till disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ZD6474
Hide Arm/Group Description:
ZD6474 300 mg by mouth daily.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: months
1.81
(0.16 to 23.46)
Time Frame Adverse events (AEs) were assessed from the time of consent until 30 days following the last dose of study treatment.
Adverse Event Reporting Description Collection period: January 16, 2007 to April 02, 2010.
 
Arm/Group Title ZD6474
Hide Arm/Group Description ZD6474 300 mg by mouth daily.
All-Cause Mortality
ZD6474
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
ZD6474
Affected / at Risk (%) # Events
Total   54/54 (100.00%)    
Blood and lymphatic system disorders   
Blood Creatinine Increased  1  5/54 (9.26%)  5
Hematocrit Decreased  1  1/54 (1.85%)  1
Leukopenia  1  4/54 (7.41%)  4
Hemorrhage  1  1/54 (1.85%)  1
Lymphopenia  1  4/54 (7.41%)  4
Thrombocytopenia  1  1/54 (1.85%)  1
Lymphadenopathy  1  1/54 (1.85%)  1
Thromboplastin  1  1/54 (1.85%)  1
Hemoptysis  1  1/54 (1.85%)  1
Tumor Hemorrhage  1  2/54 (3.70%)  2
Thrombolysis  1  1/54 (1.85%)  1
Anemia  1  5/54 (9.26%)  5
Lymphocyte Count Decreased  1  1/54 (1.85%)  1
Cardiac disorders   
Bradycardia  1  1/54 (1.85%)  1
Cardiorespiratory Arrest  1  1/54 (1.85%)  1
Cardiac Failure  1  1/54 (1.85%)  1
Pulmonary Hypertension  1  2/54 (3.70%)  2
Cerebral Hemorrhage  1  4/54 (7.41%)  4
Sinus Bradycardia  1  1/54 (1.85%)  1
Pericardial Effusion  1  1/54 (1.85%)  1
Cardiac Troponin  1  1/54 (1.85%)  1
Pulmonary Edema  1  1/54 (1.85%)  1
Pleuropericarditis  1  1/54 (1.85%)  1
Eye disorders   
Perforated Right Cornea  1  1/54 (1.85%)  1
Gastrointestinal disorders   
Large Intestine Perforation  1  2/54 (3.70%)  2
Dysgeusia  1  1/54 (1.85%)  1
Oesophageal Varices Hemorrhage  1  1/54 (1.85%)  1
Intestinal Perforation  1  5/54 (9.26%)  5
Gastrointestinal Hemorrhage  1  5/54 (9.26%)  5
Gastric Ulcer  1  2/54 (3.70%)  2
Rectal Hemorrhage  1  1/54 (1.85%)  1
Appendicitis  1  2/54 (3.70%)  2
Perforated Diverticulum  1  1/54 (1.85%)  1
Enterovesical Fistula  1  2/54 (3.70%)  2
Enterocutaneous Fistula  1  1/54 (1.85%)  1
Proctorrhagia  1  1/54 (1.85%)  1
Colitis  1  1/54 (1.85%)  1
Anal Fissure  1  1/54 (1.85%)  1
Gastroenteritis  1  2/54 (3.70%)  2
Colovesical Fistula  1  1/54 (1.85%)  1
Intestinal Obstruction  1  1/54 (1.85%)  2
Abdominal Perforation  1  1/54 (1.85%)  1
General disorders   
Epistaxis  1  2/54 (3.70%)  2
Death  1  10/54 (18.52%)  10
Chest Pain  1  3/54 (5.56%)  3
Edema Peripheral  1  1/54 (1.85%)  1
General Physical Health Deterioration  1  1/54 (1.85%)  1
Wound Complication  1  1/54 (1.85%)  1
Facial Swelling  1  1/54 (1.85%)  1
Hepatobiliary disorders   
Hypoalbuminemia  1  1/54 (1.85%)  1
Pancreatitis  1  1/54 (1.85%)  1
Gallbladder Perforation  1  1/54 (1.85%)  1
Gamma-glutamyl transferase  1  1/54 (1.85%)  1
Cholecystitis  1  2/54 (3.70%)  2
Cholelithiasis  1  1/54 (1.85%)  1
Immune system disorders   
Sepsis  1  1/54 (1.85%)  1
Infections and infestations   
Febrile Neutropenia  1  6/54 (11.11%)  6
Respiratory Infection  1  1/54 (1.85%)  1
Neutropenia  1  8/54 (14.81%)  8
Bronchitis Bacterial  1  1/54 (1.85%)  1
Opportunistic Infection  1  1/54 (1.85%)  1
Septic Shock  1  1/54 (1.85%)  1
Influenza  1  1/54 (1.85%)  1
Infection  1  4/54 (7.41%)  4
Post Operative Wound Infection  1  1/54 (1.85%)  1
Intestinal Infection  1  1/54 (1.85%)  1
Urinary Tract Infection  1  2/54 (3.70%)  2
Bartholin Abscess  1  1/54 (1.85%)  1
Investigations   
Drug Interaction  1  1/54 (1.85%)  1
Metabolism and nutrition disorders   
Hypocalcemia  1  2/54 (3.70%)  2
Lipase Abnormal  1  2/54 (3.70%)  2
Hyponatremia  1  2/54 (3.70%)  2
Tumor Lysis Syndrome  1  1/54 (1.85%)  1
Hypoglycemia  1  1/54 (1.85%)  1
Diabetic Hyperglycemic Coma  1  1/54 (1.85%)  1
Musculoskeletal and connective tissue disorders   
Joint Swelling  1  1/54 (1.85%)  1
Gait Distrubance  1  1/54 (1.85%)  1
Convulsion  1  1/54 (1.85%)  1
Muscular Weakness  1  1/54 (1.85%)  1
Fracture  1  2/54 (3.70%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Brain Neoplasm  1  1/54 (1.85%)  1
Gastric Cancer  1  1/54 (1.85%)  1
Nervous system disorders   
Depressed Level of Consciousness  1  4/54 (7.41%)  4
Hydrocephalus  1  1/54 (1.85%)  1
Pyramidal Tract Syndrome  1  1/54 (1.85%)  1
Peripheral Sensorimotor Neuropathy  1  2/54 (3.70%)  2
Peripheral Motor Neuropathy  1  1/54 (1.85%)  1
Encephalopathy  1  1/54 (1.85%)  1
Syncope  1  2/54 (3.70%)  2
Seizure  1  1/54 (1.85%)  1
Epilepsy  1  1/54 (1.85%)  1
Psychiatric disorders   
Cognitive Disorder  1  1/54 (1.85%)  1
Hallucinations  1  2/54 (3.70%)  2
Renal and urinary disorders   
Acute Renal Failure  1  2/54 (3.70%)  2
Renal Failure  1  4/54 (7.41%)  4
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1  2/54 (3.70%)  2
Chylothorax  1  1/54 (1.85%)  1
Pneumonia  1  8/54 (14.81%)  8
Pneumonia Aspiration  1  1/54 (1.85%)  1
Haemoptysis  1  1/54 (1.85%)  1
Pulmonary Hemorrhage  1  1/54 (1.85%)  1
Purulent Bronchitis  1  1/54 (1.85%)  1
Respiratory Failure  1  1/54 (1.85%)  1
Pleural Effusion  1  3/54 (5.56%)  3
Acute Respiratory Syndrome  1  1/54 (1.85%)  1
PAS Chronic  1  1/54 (1.85%)  1
Skin and subcutaneous tissue disorders   
Skin Hemorrhage  1  1/54 (1.85%)  1
Skin Ulcer  1  1/54 (1.85%)  1
Folliculitis  1  1/54 (1.85%)  1
Vascular disorders   
Multifold Ischemic Disease of CNS  1 [1]  1/54 (1.85%)  1
Papilloedema  1  1/54 (1.85%)  1
Retinal Artery Occlusion  1  1/54 (1.85%)  1
Vasculitis Cerebral  1  1/54 (1.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v3.0
[1]
CNS - Central Nervous System
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ZD6474
Affected / at Risk (%) # Events
Total   54/54 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  14/54 (25.93%)  14
Bleed  1  10/54 (18.52%)  10
Bleeding Gums  1  1/54 (1.85%)  1
Edema, Bilateral Ankles  1  1/54 (1.85%)  1
Edema, Left Neck  1  1/54 (1.85%)  1
Elevated INR  1  1/54 (1.85%)  1
Elevated Prothrombin Time  1  4/54 (7.41%)  4
Elevated Partial Thromboplastin Time  1  4/54 (7.41%)  4
Elevated WBC  1  6/54 (11.11%)  6
Leukopenia  1  3/54 (5.56%)  3
Thrombocytopenia  1  2/54 (3.70%)  2
Cardiac disorders   
Hypertension  1  18/54 (33.33%)  18
Arrythmia, Tachycardia  1  1/54 (1.85%)  1
Arrythmia,PAC's  1  1/54 (1.85%)  1
Arrythmia,Tachycardia  1  1/54 (1.85%)  1
Cardiac Ischemic  1  1/54 (1.85%)  1
Elevated Troponin  1  1/54 (1.85%)  1
Hypotension  1  1/54 (1.85%)  1
Left Ventricular Systolic Dysfunction  1  1/54 (1.85%)  1
QTC Prolongation  1  5/54 (9.26%)  5
Severe Aortic Insufficiency  1  1/54 (1.85%)  1
Ear and labyrinth disorders   
Tinnitus  1  1/54 (1.85%)  1
Endocrine disorders   
Hot Flashes  1  1/54 (1.85%)  1
Hypothyroidism  1  2/54 (3.70%)  2
Eye disorders   
Conjunctivitis  1  1/54 (1.85%)  1
Diplopia  1  1/54 (1.85%)  1
Dry Eye Syndrome  1  2/54 (3.70%)  2
Vision Floaters  1  1/54 (1.85%)  1
Gastrointestinal disorders   
Diarrhea  1  24/54 (44.44%)  24
Anorexia  1  15/54 (27.78%)  15
Gastrointestinal Complaint  1  13/54 (24.07%)  13
Abdominal Bloating  1  1/54 (1.85%)  1
Abdominal Cramps  1  1/54 (1.85%)  1
Constipation  1  3/54 (5.56%)  3
Dysgeusia  1  2/54 (3.70%)  2
Dyspepsia  1  1/54 (1.85%)  1
Dysphagia  1  2/54 (3.70%)  2
Flatulence  1  1/54 (1.85%)  1
Nausea  1  8/54 (14.81%)  8
Pain, Abdominal  1  3/54 (5.56%)  3
Pelvic Ascites  1  1/54 (1.85%)  1
Vomiting  1  5/54 (9.26%)  5
Xerostomia  1  1/54 (1.85%)  1
General disorders   
Constitutional Symptoms  1  24/54 (44.44%)  24
Pain  1  5/54 (9.26%)  5
Allergies  1  1/54 (1.85%)  1
Chills  1  1/54 (1.85%)  1
Constitutional Cold Sensitive  1  1/54 (1.85%)  1
Dehydration  1  2/54 (3.70%)  2
Epistaxis  1  2/54 (3.70%)  2
Fatigue  1  20/54 (37.04%)  20
Fever  1  2/54 (3.70%)  2
Insomnia  1  1/54 (1.85%)  1
Progression of Disease NOS  1  1/54 (1.85%)  1
Weight Loss  1  5/54 (9.26%)  5
Hepatobiliary disorders   
Abnormal Liver Enzymes  1  19/54 (35.19%)  19
Immune system disorders   
Sepsis  1  1/54 (1.85%)  1
Infections and infestations   
Infection  1  1/54 (1.85%)  1
Infection, Ear  1  1/54 (1.85%)  1
Infection, Eyes  1  1/54 (1.85%)  1
Infection, Respiratory  1  1/54 (1.85%)  1
Infection, Toenail  1  2/54 (3.70%)  2
Lymphopenia  1  2/54 (3.70%)  2
Pharyngitis  1  1/54 (1.85%)  1
Sinusitis  1  1/54 (1.85%)  1
Stomatitis  1  2/54 (3.70%)  2
Tooth Abscess  1  1/54 (1.85%)  1
Metabolism and nutrition disorders   
Elevated Alkaline Phosphatase  1  22/54 (40.74%)  22
Hyperglycemia  1  15/54 (27.78%)  15
Proteinuria  1  14/54 (25.93%)  14
Hypoalbuminemia  1  10/54 (18.52%)  10
Decreased Chloride  1  1/54 (1.85%)  1
Elevated ALT  1  16/54 (29.63%)  16
Elevated Amylase  1  1/54 (1.85%)  1
Elevated AST  1  17/54 (31.48%)  17
Elevated Creatine  1  1/54 (1.85%)  1
Elevated Creatinine  1  11/54 (20.37%)  11
Elevated Glucose  1  3/54 (5.56%)  3
Elevated Lipase  1  1/54 (1.85%)  1
Hemoglobinuria  1  3/54 (5.56%)  3
Hyperbilirubinemia  1  4/54 (7.41%)  4
Hyperkalemia  1  7/54 (12.96%)  7
Hypermagnesemia  1  2/54 (3.70%)  2
Hyperphosphatemia  1  1/54 (1.85%)  1
Hyperuricemia  1  6/54 (11.11%)  6
Hypocalcemia  1  7/54 (12.96%)  7
Hypoglycemia  1  4/54 (7.41%)  4
Hypokalemia  1  5/54 (9.26%)  5
Hypomagnesemia  1  9/54 (16.67%)  9
Hyponatremia  1  12/54 (22.22%)  12
Hypophosphatemia  1  3/54 (5.56%)  3
Musculoskeletal and connective tissue disorders   
Muscle Spasms  1  1/54 (1.85%)  1
Neuropathy  1  3/54 (5.56%)  3
Pain, Back  1  4/54 (7.41%)  4
Pain, Chest  1  2/54 (3.70%)  2
Pain, Heel  1  1/54 (1.85%)  1
Pain, Left Knee and Shin  1  1/54 (1.85%)  1
Pain, Left Scapula  1  1/54 (1.85%)  1
Pain, Lumbar  1  1/54 (1.85%)  1
Pain, Musculoskeletal  1  1/54 (1.85%)  1
Pain, Right Ear  1  1/54 (1.85%)  1
Pain, Right Foot  1  1/54 (1.85%)  1
Pain, Right Side  1  1/54 (1.85%)  1
Pain, Waist to Shoulder  1  1/54 (1.85%)  1
Pain, Right Arm  1  1/54 (1.85%)  1
Unsteady Gait  1  1/54 (1.85%)  1
Weakness  1  1/54 (1.85%)  1
Nervous system disorders   
Ataxia  1  1/54 (1.85%)  1
Central Nervous System Hemorrhage  1  1/54 (1.85%)  1
Confusion  1  1/54 (1.85%)  1
Depression  1  2/54 (3.70%)  2
Dizziness  1  6/54 (11.11%)  6
Dysphasia  1  1/54 (1.85%)  1
Headache  1  2/54 (3.70%)  2
Seizures  1  3/54 (5.56%)  3
Tremors  1  2/54 (3.70%)  2
Renal and urinary disorders   
Abnormal Electrolytes  1  25/54 (46.30%)  25
Renal Insufficiency  1  12/54 (22.22%)  12
Decreased GFR  1  1/54 (1.85%)  1
Dysuria  1  1/54 (1.85%)  1
Urinary Tract Infection  1  6/54 (11.11%)  6
Respiratory, thoracic and mediastinal disorders   
Pulmonary  1  11/54 (20.37%)  11
Cough  1  5/54 (9.26%)  5
Dyspnea  1  10/54 (18.52%)  10
Hemoptysis  1  4/54 (7.41%)  4
Hiccups  1  1/54 (1.85%)  1
Hoarseness  1  2/54 (3.70%)  2
Hypoxia  1  1/54 (1.85%)  1
Pleural Effusion  1  3/54 (5.56%)  3
Pneumonia  1  1/54 (1.85%)  1
Upper Respiratory Infection  1  1/54 (1.85%)  1
Wheezing  1  1/54 (1.85%)  1
Skin and subcutaneous tissue disorders   
Rash  1  11/54 (20.37%)  11
Alopecia  1  2/54 (3.70%)  2
Brusing  1  1/54 (1.85%)  1
Dry Skin  1  4/54 (7.41%)  4
Eczema  1  1/54 (1.85%)  1
Pruritus  1  2/54 (3.70%)  2
Rash, Acneiform  1  5/54 (9.26%)  5
Rash, Chest  1  1/54 (1.85%)  1
Rash, Pubic Area  1  1/54 (1.85%)  1
Rash, Hands  1  3/54 (5.56%)  3
Rash, Face  1  4/54 (7.41%)  4
Vascular disorders   
Deep Vein Thrombosis  1  2/54 (3.70%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anne S. Tsao, MD / Associate Professor, Thoracic/Head & Neck Med Oncology
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-6363
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00410189    
Other Study ID Numbers: 2005-0825
First Submitted: December 8, 2006
First Posted: December 12, 2006
Results First Submitted: March 17, 2015
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015