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Trial record 66 of 144 for:    "Acute promyelocytic leukemia"

Selumetinib in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia

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: NCT00588809
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : August 5, 2015
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Promyelocytic Leukemia (M3)
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Recurrent Adult Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Intervention Drug: selumetinib
Enrollment 47
Recruitment Details  
Pre-assignment Details A Simon, optimal two-stage design was employed for subjects without FLT3 ITD mutations. The study also included a second cohort of subjects with FLT3 ITD mutations.
Arm/Group Title Selumetinib
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Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

Period Title: Overall Study
Started 47
Completed 47
Not Completed 0
Arm/Group Title Selumetinib
Hide Arm/Group Description

Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 47 participants
69
(26 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
20
  42.6%
Male
27
  57.4%
1.Primary Outcome
Title Response Rate for Subjects Without FLT3 ITD Mutation
Hide Description

Responses were defined using standard criteria developed by an International Working Group.

[Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 2003;21:4642–9.]

In this primary outcome, we report the proportion of subjects without FLT3 ITD mutation that experienced a complete response (CR), partial response (PR), minor response (MR), or unconfirmed minor response (uMR).

Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis only includes subjects without FLT3 ITD mutation.
Arm/Group Title Selumetinib
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: percentage of participants
16.67
2.Secondary Outcome
Title Proportion of Subjects With Baseline p-ERK Activation
Hide Description Proportion of subjects with baseline p-ERK activation
Time Frame baseline (0 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes the 20 patients with samples available for analysis.
Arm/Group Title Selumetinib
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
85
3.Secondary Outcome
Title Proportion of Subjects With NRAS Mutation
Hide Description Proportion of Subjects With NRAS Mutation
Time Frame baseline (0 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes the 41 patients with samples available for analysis.
Arm/Group Title Selumetinib
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
7
4.Secondary Outcome
Title Proportion of Subjects With KRAS Mutation
Hide Description Proportion of subjects with KRAS mutation
Time Frame baseline (0 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes the 41 patients with samples available for analysis.
Arm/Group Title Selumetinib
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
2
5.Secondary Outcome
Title Proportion of Subjects With FLT3 ITD Mutation
Hide Description Proportion of subjects with FLT3 ITD mutation
Time Frame baseline (0 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
FLT3 ITD mutation status was not available for one patient.
Arm/Group Title Selumetinib
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of participants
22
6.Secondary Outcome
Title Proportion of Subjects With KIT Mutation
Hide Description Proportion of subjects with KIT mutation
Time Frame baseline (0 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes the 41 patients with samples available for analysis.
Arm/Group Title Selumetinib
Hide Arm/Group Description:

Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Selumetinib
Hide Arm/Group Description

Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

selumetinib: Given PO

All-Cause Mortality
Selumetinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Selumetinib
Affected / at Risk (%)
Total   38/47 (80.85%) 
Blood and lymphatic system disorders   
Anemia * 1 [1]  2/47 (4.26%) 
Febrile neutropenia * 1 [2]  8/47 (17.02%) 
Cardiac disorders   
Ventricular tachycardia * 1 [3]  1/47 (2.13%) 
Gastrointestinal disorders   
Diarrhea * 1 [4]  2/47 (4.26%) 
Dry mouth * 1 [5]  1/47 (2.13%) 
Mucositis oral * 1 [6]  2/47 (4.26%) 
Nausea * 1 [7]  2/47 (4.26%) 
Vomiting * 1 [8]  3/47 (6.38%) 
General disorders   
Death NOS * 1 [9]  10/47 (21.28%) 
Fatigue * 1 [10]  3/47 (6.38%) 
Fever * 1 [11]  2/47 (4.26%) 
Infections and infestations   
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Blood * 1  4/47 (8.51%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Lung (pneumonia) * 1  3/47 (6.38%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Rectum * 1  1/47 (2.13%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Salivary gland * 1  1/47 (2.13%) 
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): Skin (cellulitis) * 1  1/47 (2.13%) 
Infection with normal ANC or Grade 1 or 2 neutrophils: Blood * 1  2/47 (4.26%) 
Infections and infestations - Other * 1  11/47 (23.40%) 
Lung infection * 1 [12]  3/47 (6.38%) 
peritonsillar abscess * 1  1/47 (2.13%) 
Pharyngitis * 1 [13]  1/47 (2.13%) 
Sepsis * 1 [14]  1/47 (2.13%) 
Upper respiratory infection * 1 [15]  1/47 (2.13%) 
Urinary tract infection * 1 [16]  1/47 (2.13%) 
Investigations   
Alanine aminotransferase increased * 1 [17]  1/47 (2.13%) 
Creatinine increased * 1 [18]  1/47 (2.13%) 
Neutrophil count decreased * 1 [19]  1/47 (2.13%) 
Platelet count decreased * 1 [20]  3/47 (6.38%) 
White blood cell decreased * 1 [21]  1/47 (2.13%) 
Metabolism and nutrition disorders   
Acidosis * 1 [22]  1/47 (2.13%) 
Anorexia * 1 [23]  1/47 (2.13%) 
Dehydration * 1 [24]  5/47 (10.64%) 
Hyperuricemia * 1 [25]  1/47 (2.13%) 
Hypoalbuminemia * 1 [26]  1/47 (2.13%) 
Hypokalemia * 1 [27]  1/47 (2.13%) 
Hyponatremia * 1 [28]  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness lower limb * 1 [29]  1/47 (2.13%) 
Nervous system disorders   
Dizziness * 1 [30]  2/47 (4.26%) 
Dysphasia * 1 [31]  1/47 (2.13%) 
Intracranial hemorrhage * 1 [32]  4/47 (8.51%) 
Psychiatric disorders   
Psychosis * 1 [33]  1/47 (2.13%) 
Renal and urinary disorders   
Urine discoloration * 1 [34]  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary hemorrhage * 1 [35]  1/47 (2.13%) 
Dyspnea * 1 [36]  2/47 (4.26%) 
Epistaxis * 1 [37]  1/47 (2.13%) 
Hypoxia * 1 [38]  1/47 (2.13%) 
Pneumonitis * 1 [39]  3/47 (6.38%) 
Vascular disorders   
Hypotension * 1 [40]  3/47 (6.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.0
[1]
A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood.
[2]
A disorder characterized by an ANC <1000/mm3 and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour
[3]
A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates distal to the bundle of His.
[4]
A disorder characterized by frequent and watery bowel movements.
[5]
A disorder characterized by reduced salivary flow in the oral cavity.
[6]
A disorder characterized by inflammation of the oral mucosal.
[7]
A disorder characterized by a queasy sensation and/or the urge to vomit.
[8]
A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
[9]
A cessation of life that cannot be attributed to a CTCAE term associated with Grade 5.
[10]
A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
[11]
A disorder characterized by elevation of the body's temperature above the upper limit of normal.
[12]
A disorder characterized by an infectious process involving the lungs.
[13]
A disorder characterized by inflammation of the throat.
[14]
A disorder characterized by the presence of pathogenic microorganisms in the blood stream that cause a rapidly progressing systemic reaction that may lead to shock.
[15]
A disorder characterized by an infectious process involving the upper respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea).
[16]
A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra.
[17]
A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen.
[18]
A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.
[19]
A finding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen.
[20]
A finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen.
[21]
A finding based on laboratory test results that indicate an decrease in number of white blood cells in a blood specimen.
[22]
A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues.
[23]
A disorder characterized by a loss of appetite.
[24]
A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.
[25]
A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid.
[26]
A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood.
[27]
A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.
[28]
A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.
[29]
A disorder characterized by a reduction in the strength of the lower limb muscles.
[30]
A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking.
[31]
A disorder characterized by impairment of verbal communication skills, often resulting from brain damage.
[32]
A disorder characterized by bleeding from the cranium.
[33]
A disorder characterized by personality change, impaired functioning, and loss of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder or brain tumor.
[34]
A disorder characterized by a change in the color of the urine.
[35]
A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.
[36]
A disorder characterized by an uncomfortable sensation of difficulty breathing.
[37]
A disorder characterized by bleeding from the nose.
[38]
A disorder characterized by a decrease in the level of oxygen in the body.
[39]
A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.
[40]
A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Selumetinib
Affected / at Risk (%)
Total   47/47 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1 [1]  24/47 (51.06%) 
Febrile neutropenia * 1 [2]  3/47 (6.38%) 
Cardiac disorders   
Atrial fibrillation * 1 [3]  3/47 (6.38%) 
Paroxysmal atrial tachycardia * 1 [4]  4/47 (8.51%) 
Sinus tachycardia * 1 [5]  13/47 (27.66%) 
Gastrointestinal disorders   
Abdominal distension * 1 [6]  7/47 (14.89%) 
Abdominal pain * 1 [7]  13/47 (27.66%) 
Constipation * 1 [8]  4/47 (8.51%) 
Diarrhea * 1 [9]  29/47 (61.70%) 
Dry mouth * 1 [10]  6/47 (12.77%) 
Dyspepsia * 1 [11]  3/47 (6.38%) 
Hemorrhoids * 1 [12]  4/47 (8.51%) 
Mucositis oral * 1 [13]  9/47 (19.15%) 
Nausea * 1 [14]  24/47 (51.06%) 
Oral hemorrhage * 1 [15]  5/47 (10.64%) 
Vomiting * 1 [16]  15/47 (31.91%) 
General disorders   
Chills * 1 [17]  16/47 (34.04%) 
Edema limbs * 1 [18]  21/47 (44.68%) 
Fatigue * 1 [19]  32/47 (68.09%) 
Fever * 1 [20]  21/47 (44.68%) 
Non-cardiac chest pain * 1 [21]  7/47 (14.89%) 
Pain * 1 [22]  6/47 (12.77%) 
Immune system disorders   
Allergic reaction * 1 [23]  5/47 (10.64%) 
Infections and infestations   
Infections and infestations - Other * 1  9/47 (19.15%) 
Urinary tract infection * 1 [24]  3/47 (6.38%) 
Injury, poisoning and procedural complications   
Bruising * 1 [25]  3/47 (6.38%) 
Investigations   
Alanine aminotransferase increased * 1 [26]  16/47 (34.04%) 
Alkaline phosphatase increased * 1 [27]  7/47 (14.89%) 
Aspartate aminotransferase increased * 1 [28]  19/47 (40.43%) 
Blood bilirubin increased * 1 [29]  5/47 (10.64%) 
Creatinine increased * 1 [30]  7/47 (14.89%) 
Lymphocyte count decreased * 1 [31]  8/47 (17.02%) 
Neutrophil count decreased * 1 [32]  20/47 (42.55%) 
Platelet count decreased * 1 [33]  24/47 (51.06%) 
Weight loss * 1 [34]  3/47 (6.38%) 
White blood cell decreased * 1 [35]  13/47 (27.66%) 
Metabolism and nutrition disorders   
Acidosis * 1 [36]  5/47 (10.64%) 
Anorexia * 1 [37]  19/47 (40.43%) 
Dehydration * 1 [38]  4/47 (8.51%) 
Hyperglycemia * 1 [39]  17/47 (36.17%) 
Hyperuricemia * 1 [40]  3/47 (6.38%) 
Hypoalbuminemia * 1 [41]  20/47 (42.55%) 
Hypocalcemia * 1 [42]  13/47 (27.66%) 
Hypoglycemia * 1 [43]  3/47 (6.38%) 
Hypokalemia * 1 [44]  12/47 (25.53%) 
Hypomagnesemia * 1 [45]  9/47 (19.15%) 
Hyponatremia * 1 [46]  15/47 (31.91%) 
Hypophosphatemia * 1 [47]  5/47 (10.64%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1 [48]  3/47 (6.38%) 
Back pain * 1 [49]  9/47 (19.15%) 
Generalized muscle weakness * 1 [50]  4/47 (8.51%) 
Muscle weakness lower limb * 1 [51]  4/47 (8.51%) 
Nervous system disorders   
Dizziness * 1 [52]  10/47 (21.28%) 
Headache * 1 [53]  12/47 (25.53%) 
Psychiatric disorders   
Confusion * 1 [54]  4/47 (8.51%) 
Depression * 1 [55]  4/47 (8.51%) 
Renal and urinary disorders   
Proteinuria * 1 [56]  4/47 (8.51%) 
Urinary retention * 1 [57]  3/47 (6.38%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1 [58]  18/47 (38.30%) 
Dyspnea * 1 [59]  19/47 (40.43%) 
Epistaxis * 1 [60]  9/47 (19.15%) 
Hypoxia * 1 [61]  5/47 (10.64%) 
Pharyngolaryngeal pain * 1 [62]  4/47 (8.51%) 
Pleural effusion * 1 [63]  5/47 (10.64%) 
Pneumonitis * 1 [64]  3/47 (6.38%) 
Respiratory, thoracic and mediastinal disorders - Other, specify * 1  3/47 (6.38%) 
Skin and subcutaneous tissue disorders   
Dry skin * 1 [65]  3/47 (6.38%) 
Hyperhidrosis * 1 [66]  4/47 (8.51%) 
Purpura * 1 [67]  4/47 (8.51%) 
Rash maculo-papular * 1 [68]  10/47 (21.28%) 
Skin and subcutaneous tissue disorders - Other * 1  3/47 (6.38%) 
Vascular disorders   
Hypertension * 1 [69]  9/47 (19.15%) 
Hypotension * 1 [70]  7/47 (14.89%) 
Vascular disorders - Other * 1  5/47 (10.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE 4.0
[1]
A disorder characterized by an reduction in the amount of hemoglobin in 100 ml of blood.
[2]
A disorder characterized by an ANC <1000/mm3 and a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour
[3]
A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular response due to multiple reentry circuits. The rhythm disturbance originates above the ventricles.
[4]
A disorder characterized by a dysrhythmia with abrupt onset and sudden termination of atrial contractions with a rate of 150-250 beats per minute. The rhythm disturbance originates in the atria.
[5]
A disorder characterized by a dysrhythmia with a heart rate greater than 100 beats per minute that originates in the sinus node.
[6]
A disorder characterized by swelling of the abdomen.
[7]
A disorder characterized by a sensation of marked discomfort in the abdominal region.
[8]
A disorder characterized by irregular and infrequent or difficult evacuation of the bowels.
[9]
A disorder characterized by frequent and watery bowel movements.
[10]
A disorder characterized by reduced salivary flow in the oral cavity.
[11]
A disorder characterized by an uncomfortable, often painful feeling in the stomach, resulting from impaired digestion. Symptoms include burning stomach, bloating, heartburn, nausea and vomiting.
[12]
A disorder characterized by the presence of dilated veins in the rectum and surrounding area.
[13]
A disorder characterized by inflammation of the oral mucosal.
[14]
A disorder characterized by a queasy sensation and/or the urge to vomit.
[15]
A disorder characterized by bleeding from the mouth.
[16]
A disorder characterized by the reflexive act of ejecting the contents of the stomach through the mouth.
[17]
A disorder characterized by a sensation of cold that often marks a physiologic response to sweating after a fever.
[18]
A disorder characterized by swelling due to excessive fluid accumulation in the upper or lower extremities.
[19]
A disorder characterized by a state of generalized weakness with a pronounced inability to summon sufficient energy to accomplish daily activities.
[20]
A disorder characterized by elevation of the body's temperature above the upper limit of normal.
[21]
A disorder characterized by discomfort in the chest unrelated to a heart disorder.
[22]
A disorder characterized by the sensation of marked discomfort, distress or agony.
[23]
A disorder characterized by an adverse local or general response from exposure to an allergen.
[24]
A disorder characterized by an infectious process involving the urinary tract, most commonly the bladder and the urethra.
[25]
A finding of injury of the soft tissues or bone characterized by leakage of blood into surrounding tissues.
[26]
A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen.
[27]
A finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase in a blood specimen.
[28]
A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen.
[29]
A finding based on laboratory test results that indicate an abnormally high level of bilirubin in the blood. Excess bilirubin is associated with jaundice.
[30]
A finding based on laboratory test results that indicate increased levels of creatinine in a biological specimen.
[31]
A finding based on laboratory test results that indicate a decrease in number of lymphocytes in a blood specimen.
[32]
A finding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen.
[33]
A finding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen.
[34]
A finding characterized by a decrease in overall body weight; for pediatrics, less than the baseline growth curve.
[35]
A finding based on laboratory test results that indicate an decrease in number of white blood cells in a blood specimen.
[36]
A disorder characterized by abnormally high acidity (high hydrogen-ion concentration) of the blood and other body tissues.
[37]
A disorder characterized by a loss of appetite.
[38]
A disorder characterized by excessive loss of water from the body. It is usually caused by severe diarrhea, vomiting or diaphoresis.
[39]
A disorder characterized by laboratory test results that indicate an elevation in the concentration of blood sugar. It is usually an indication of diabetes mellitus or glucose intolerance.
[40]
A disorder characterized by laboratory test results that indicate an elevation in the concentration of uric acid.
[41]
A disorder characterized by laboratory test results that indicate a low concentration of albumin in the blood.
[42]
A disorder characterized by laboratory test results that indicate a low concentration of calcium (corrected for albumin) in the blood.
[43]
A disorder characterized by laboratory test results that indicate a low concentration of glucose in the blood.
[44]
A disorder characterized by laboratory test results that indicate a low concentration of potassium in the blood.
[45]
A disorder characterized by laboratory test results that indicate a low concentration of magnesium in the blood.
[46]
A disorder characterized by laboratory test results that indicate a low concentration of sodium in the blood.
[47]
A disorder characterized by laboratory test results that indicate a low concentration of phosphates in the blood.
[48]
A disorder characterized by a sensation of marked discomfort in a joint.
[49]
A disorder characterized by marked discomfort sensation in the back region.
[50]
A disorder characterized by a reduction in the strength of muscles in multiple anatomic sites.
[51]
A disorder characterized by a reduction in the strength of the lower limb muscles.
[52]
A disorder characterized by a disturbing sensation of lightheadedness, unsteadiness, giddiness, spinning or rocking.
[53]
A disorder characterized by a sensation of marked discomfort in various parts of the head, not confined to the area of distribution of any nerve.
[54]
A disorder characterized by a lack of clear and orderly thought and behavior.
[55]
A disorder characterized by melancholic feelings of grief or unhappiness.
[56]
A disorder characterized by laboratory test results that indicate the presence of excessive protein in the urine. It is predominantly albumin, but also globulin.
[57]
A disorder characterized by accumulation of urine within the bladder because of the inability to urinate.
[58]
A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound.
[59]
A disorder characterized by an uncomfortable sensation of difficulty breathing.
[60]
A disorder characterized by bleeding from the nose.
[61]
A disorder characterized by a decrease in the level of oxygen in the body.
[62]
A disorder characterized by marked discomfort sensation in the pharyngolaryngeal region.
[63]
A disorder characterized by an increase in amounts of fluid within the pleural cavity. Symptoms include shortness of breath, cough and marked chest discomfort.
[64]
A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.
[65]
A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture.
[66]
A disorder characterized by excessive perspiration.
[67]
A disorder characterized by hemorrhagic areas of the skin and mucous membrane. Newer lesions appear reddish in color. Older lesions are usually a darker purple color and eventually become a brownish-yellow color.
[68]
A disorder characterized by the presence of macules (flat) and papules (elevated). Also known as morbillform rash.
[69]
A disorder characterized by a pathological increase in blood pressure; a repeatedly elevation in the blood pressure exceeding 140 over 90 mm Hg.
[70]
A disorder characterized by a blood pressure that is below the normal expected for an individual in a given environment.
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
Layout table for Results Point of Contact information
Name/Title: Olatoyosi Odenike, MD
Organization: The University of Chicago Medicine
Phone: (773) 702-6149
EMail: todenike@medicine.bsd.uchicago.edu
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00588809     History of Changes
Other Study ID Numbers: NCI-2009-00250
15455B
N01CM62209 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
First Submitted: December 21, 2007
First Posted: January 9, 2008
Results First Submitted: July 6, 2015
Results First Posted: August 5, 2015
Last Update Posted: August 5, 2015