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Combination Chemotherapy and Dasatinib in Treating Patients With Newly Diagnosed 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: NCT01238211
Recruitment Status : Active, not recruiting
First Posted : November 10, 2010
Results First Posted : August 12, 2014
Last Update Posted : September 24, 2019
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 Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
Core Binding Factor Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Therapy-Related Acute Myeloid Leukemia
Interventions Drug: Cytarabine
Drug: Dasatinib
Drug: Daunorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Enrollment 61
Recruitment Details Between April 2011 and January 2013, 61 participants were recruited.
Pre-assignment Details  
Arm/Group Title Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
Hide Arm/Group Description

INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.

CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.

CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.

Period Title: Overall Study
Started 61
Completed 3
Not Completed 58
Reason Not Completed
Continues active treatment             31
Adverse Event             7
Death             4
Relapse/Progression             2
Withdrawal by Subject             7
Non-protocol treatment             4
Investigator/Patient Decision             3
Arm/Group Title Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
Hide Arm/Group Description

INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.

CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.

CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.

Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants
51
(19.8 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
30
  49.2%
Male
31
  50.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
54
  88.5%
Unknown or Not Reported
7
  11.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.6%
Native Hawaiian or Other Pacific Islander
1
   1.6%
Black or African American
5
   8.2%
White
46
  75.4%
More than one race
0
   0.0%
Unknown or Not Reported
8
  13.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants
61
1.Primary Outcome
Title 30 Day Survival Rate
Hide Description Percentage of participants who were alive 30 days after starting induction treatment.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
Hide Arm/Group Description:

INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.

CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.

CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.

Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97
(89 to 99.6)
2.Secondary Outcome
Title Event-free Survival
Hide Description

Event free survival (EFS) is defined as the time from registration to failure to achieve complete remission (CR), relapse after CR is attained or death, whichever comes first. The median EFS with 95% CI was estimated using the Kaplan-Meier method,

Complete remission (CR) is defined as: disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 10^9/L and platelet count > 100 x 10^9/L, and normal bone marrow differential (< 5% blasts).

Time Frame Up to 10 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Complete Response Rate
Hide Description

Percentage of participants who achieve a CR.

CR is defined in the above outcome measure.

Time Frame Up to 10 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Cumulative Incidence of Relapse
Hide Description [Not Specified]
Time Frame Up to 10 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Cumulative Incidence of Death
Hide Description [Not Specified]
Time Frame Up to 10 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Disease-free Survival
Hide Description Disease free survival (DFS) is defined as the time from achievement of CR to relapse or death, whichever comes first. The median DFS with 95% CI was estimated using the Kaplan-Meier method.
Time Frame Up to 10 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is defined as time from registration to death. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Time Frame Up to 10 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Only 55 participants were evaluable for adverse events at the time of analysis.
 
Arm/Group Title Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
Hide Arm/Group Description CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
All-Cause Mortality
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
Affected / at Risk (%) # Events
Total   27/55 (49.09%)    
Blood and lymphatic system disorders   
Anemia  1  26/55 (47.27%)  41
Blood and lymphatic system disorders - Other  1  1/55 (1.82%)  1
Disseminated intravascular coagulation  1  1/55 (1.82%)  1
Febrile neutropenia  1  18/55 (32.73%)  25
Cardiac disorders   
Atrial fibrillation  1  2/55 (3.64%)  2
Atrial flutter  1  1/55 (1.82%)  1
Cardiac arrest  1  1/55 (1.82%)  1
Chest pain - cardiac  1  2/55 (3.64%)  2
Palpitations  1  1/55 (1.82%)  1
Sinus tachycardia  1  11/55 (20.00%)  13
Supraventricular tachycardia  1  1/55 (1.82%)  1
Ventricular arrhythmia  1  1/55 (1.82%)  1
Ventricular tachycardia  1  2/55 (3.64%)  2
Endocrine disorders   
Hyperthyroidism  1  1/55 (1.82%)  1
Eye disorders   
Blurred vision  1  1/55 (1.82%)  1
Conjunctivitis  1  1/55 (1.82%)  1
Dry eye  1  1/55 (1.82%)  1
Eye disorders - Other  1  1/55 (1.82%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/55 (1.82%)  1
Abdominal pain  1  4/55 (7.27%)  4
Ascites  1  1/55 (1.82%)  1
Colitis  1  1/55 (1.82%)  1
Constipation  1  6/55 (10.91%)  7
Dental caries  1  1/55 (1.82%)  1
Diarrhea  1  13/55 (23.64%)  17
Dyspepsia  1  2/55 (3.64%)  2
Dysphagia  1  1/55 (1.82%)  1
Fecal incontinence  1  1/55 (1.82%)  1
Flatulence  1  1/55 (1.82%)  1
Gastritis  1  1/55 (1.82%)  2
Gastroesophageal reflux disease  1  1/55 (1.82%)  2
Gastrointestinal disorders - Other  1  3/55 (5.45%)  4
Gastrointestinal pain  1  1/55 (1.82%)  1
Hemorrhoids  1  1/55 (1.82%)  1
Ileus  1  1/55 (1.82%)  1
Mucositis oral  1  4/55 (7.27%)  4
Nausea  1  20/55 (36.36%)  29
Oral hemorrhage  1  1/55 (1.82%)  1
Oral pain  1  2/55 (3.64%)  2
Toothache  1  1/55 (1.82%)  2
Typhlitis  1  1/55 (1.82%)  1
Upper gastrointestinal hemorrhage  1  2/55 (3.64%)  3
Vomiting  1  13/55 (23.64%)  16
General disorders   
Chills  1  5/55 (9.09%)  5
Edema face  1  1/55 (1.82%)  2
Edema limbs  1  5/55 (9.09%)  6
Edema trunk  1  2/55 (3.64%)  2
Fatigue  1  22/55 (40.00%)  34
Fever  1  9/55 (16.36%)  11
General disorders and administration site conditions - Other  1  5/55 (9.09%)  5
Infusion related reaction  1  1/55 (1.82%)  2
Malaise  1  3/55 (5.45%)  3
Multi-organ failure  1  1/55 (1.82%)  1
Non-cardiac chest pain  1  1/55 (1.82%)  1
Pain  1  5/55 (9.09%)  9
Hepatobiliary disorders   
Hepatic hemorrhage  1  1/55 (1.82%)  1
Infections and infestations   
Catheter related infection  1  2/55 (3.64%)  2
Enterocolitis infectious  1  1/55 (1.82%)  1
Infections and infestations - Other  1  3/55 (5.45%)  3
Lung infection  1  8/55 (14.55%)  9
Mucosal infection  1  2/55 (3.64%)  2
Sepsis  1  6/55 (10.91%)  8
Sinusitis  1  1/55 (1.82%)  1
Skin infection  1  2/55 (3.64%)  3
Small intestine infection  1  1/55 (1.82%)  1
Urinary tract infection  1  1/55 (1.82%)  1
Injury, poisoning and procedural complications   
Bruising  1  2/55 (3.64%)  2
Fall  1  1/55 (1.82%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  9/55 (16.36%)  10
Alanine aminotransferase increased  1  15/55 (27.27%)  20
Alkaline phosphatase increased  1  9/55 (16.36%)  14
Aspartate aminotransferase increased  1  17/55 (30.91%)  20
Blood bilirubin increased  1  10/55 (18.18%)  14
Cardiac troponin I increased  1  1/55 (1.82%)  1
Creatinine increased  1  11/55 (20.00%)  16
Electrocardiogram QT corrected interval prolonged  1  6/55 (10.91%)  9
Hemoglobin increased  1  1/55 (1.82%)  1
INR increased  1  9/55 (16.36%)  11
Investigations - Other  1  3/55 (5.45%)  4
Lymphocyte count decreased  1  18/55 (32.73%)  26
Lymphocyte count increased  1  2/55 (3.64%)  2
Neutrophil count decreased  1  26/55 (47.27%)  43
Platelet count decreased  1  27/55 (49.09%)  45
Weight gain  1  1/55 (1.82%)  1
Weight loss  1  6/55 (10.91%)  11
White blood cell decreased  1  18/55 (32.73%)  29
Metabolism and nutrition disorders   
Acidosis  1  4/55 (7.27%)  4
Alkalosis  1  2/55 (3.64%)  2
Anorexia  1  11/55 (20.00%)  18
Dehydration  1  3/55 (5.45%)  5
Hyperglycemia  1  19/55 (34.55%)  28
Hyperkalemia  1  7/55 (12.73%)  7
Hypermagnesemia  1  3/55 (5.45%)  3
Hypernatremia  1  4/55 (7.27%)  5
Hyperuricemia  1  6/55 (10.91%)  6
Hypoalbuminemia  1  21/55 (38.18%)  34
Hypocalcemia  1  12/55 (21.82%)  17
Hypoglycemia  1  3/55 (5.45%)  3
Hypokalemia  1  16/55 (29.09%)  18
Hypomagnesemia  1  6/55 (10.91%)  11
Hyponatremia  1  13/55 (23.64%)  19
Hypophosphatemia  1  6/55 (10.91%)  9
Metabolism and nutrition disorders - Other  1  2/55 (3.64%)  4
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/55 (5.45%)  5
Back pain  1  1/55 (1.82%)  1
Generalized muscle weakness  1  4/55 (7.27%)  8
Musculoskeletal and connective tissue disorder - Other  1  2/55 (3.64%)  3
Myalgia  1  2/55 (3.64%)  2
Neck pain  1  1/55 (1.82%)  1
Pain in extremity  1  2/55 (3.64%)  2
Nervous system disorders   
Ataxia  1  1/55 (1.82%)  1
Dizziness  1  5/55 (9.09%)  7
Dysgeusia  1  2/55 (3.64%)  2
Headache  1  12/55 (21.82%)  17
Hydrocephalus  1  1/55 (1.82%)  1
Intracranial hemorrhage  1  1/55 (1.82%)  1
Lethargy  1  1/55 (1.82%)  1
Nervous system disorders - Other  1  1/55 (1.82%)  1
Paresthesia  1  1/55 (1.82%)  1
Peripheral sensory neuropathy  1  3/55 (5.45%)  3
Sinus pain  1  1/55 (1.82%)  1
Somnolence  1  1/55 (1.82%)  1
Syncope  1  2/55 (3.64%)  2
Tremor  1  1/55 (1.82%)  1
Psychiatric disorders   
Agitation  1  1/55 (1.82%)  1
Anxiety  1  5/55 (9.09%)  6
Confusion  1  1/55 (1.82%)  1
Delirium  1  1/55 (1.82%)  2
Depression  1  3/55 (5.45%)  5
Insomnia  1  3/55 (5.45%)  5
Renal and urinary disorders   
Acute kidney injury  1  7/55 (12.73%)  9
Chronic kidney disease  1  2/55 (3.64%)  4
Hematuria  1  4/55 (7.27%)  6
Proteinuria  1  7/55 (12.73%)  9
Urinary frequency  1  1/55 (1.82%)  1
Urinary incontinence  1  1/55 (1.82%)  1
Urinary tract pain  1  1/55 (1.82%)  1
Reproductive system and breast disorders   
Genital edema  1  1/55 (1.82%)  1
Menorrhagia  1  1/55 (1.82%)  1
Perineal pain  1  1/55 (1.82%)  1
Vaginal hemorrhage  1  1/55 (1.82%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  7/55 (12.73%)  7
Dyspnea  1  11/55 (20.00%)  13
Epistaxis  1  1/55 (1.82%)  1
Hypoxia  1  3/55 (5.45%)  4
Nasal congestion  1  1/55 (1.82%)  1
Pharyngolaryngeal pain  1  1/55 (1.82%)  1
Pleural effusion  1  4/55 (7.27%)  5
Pleuritic pain  1  1/55 (1.82%)  1
Pneumonitis  1  2/55 (3.64%)  2
Respiratory failure  1  5/55 (9.09%)  5
Respiratory, thoracic and mediastinal disorders - Other  1  3/55 (5.45%)  3
Sore throat  1  3/55 (5.45%)  3
Wheezing  1  1/55 (1.82%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  3/55 (5.45%)  3
Dry skin  1  2/55 (3.64%)  2
Erythema multiforme  1  1/55 (1.82%)  2
Palmar-plantar erythrodysesthesia syndrome  1  1/55 (1.82%)  1
Pruritus  1  1/55 (1.82%)  1
Purpura  1  2/55 (3.64%)  3
Rash maculo-papular  1  8/55 (14.55%)  12
Skin and subcutaneous tissue disorders - Other  1  4/55 (7.27%)  7
Skin ulceration  1  1/55 (1.82%)  1
Vascular disorders   
Flushing  1  1/55 (1.82%)  1
Hypertension  1  5/55 (9.09%)  7
Hypotension  1  9/55 (16.36%)  12
Peripheral ischemia  1  1/55 (1.82%)  1
Vascular disorders - Other  1  1/55 (1.82%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)
Affected / at Risk (%) # Events
Total   51/55 (92.73%)    
Blood and lymphatic system disorders   
Anemia  1  49/55 (89.09%)  327
Blood and lymphatic system disorders - Other  1  2/55 (3.64%)  3
Disseminated intravascular coagulation  1  6/55 (10.91%)  7
Febrile neutropenia  1  31/55 (56.36%)  63
Leukocytosis  1  3/55 (5.45%)  3
Lymph node pain  1  2/55 (3.64%)  3
Cardiac disorders   
Atrioventricular block first degree  1  1/55 (1.82%)  3
Cardiac disorders - Other  1  3/55 (5.45%)  4
Chest pain - cardiac  1  2/55 (3.64%)  2
Heart failure  1  3/55 (5.45%)  4
Left ventricular systolic dysfunction  1  3/55 (5.45%)  7
Mitral valve disease  1  1/55 (1.82%)  3
Palpitations  1  5/55 (9.09%)  6
Sinus bradycardia  1  3/55 (5.45%)  3
Sinus tachycardia  1  16/55 (29.09%)  38
Ventricular arrhythmia  1  2/55 (3.64%)  2
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other  1  1/55 (1.82%)  1
Endocrine disorders   
Hypothyroidism  1  1/55 (1.82%)  1
Eye disorders   
Blurred vision  1  6/55 (10.91%)  10
Conjunctivitis  1  3/55 (5.45%)  3
Eye disorders - Other  1  3/55 (5.45%)  4
Eye pain  1  2/55 (3.64%)  2
Floaters  1  1/55 (1.82%)  1
Keratitis  1  2/55 (3.64%)  2
Photophobia  1  2/55 (3.64%)  2
Retinal vascular disorder  1  1/55 (1.82%)  1
Gastrointestinal disorders   
Abdominal distension  1  2/55 (3.64%)  3
Abdominal pain  1  12/55 (21.82%)  22
Anal hemorrhage  1  2/55 (3.64%)  3
Anal pain  1  2/55 (3.64%)  2
Ascites  1  2/55 (3.64%)  3
Bloating  1  1/55 (1.82%)  1
Constipation  1  30/55 (54.55%)  61
Dental caries  1  2/55 (3.64%)  2
Diarrhea  1  44/55 (80.00%)  91
Dyspepsia  1  3/55 (5.45%)  4
Dysphagia  1  5/55 (9.09%)  8
Enterocolitis  1  1/55 (1.82%)  1
Fecal incontinence  1  1/55 (1.82%)  1
Flatulence  1  2/55 (3.64%)  4
Gastric hemorrhage  1  1/55 (1.82%)  1
Gastritis  1  1/55 (1.82%)  1
Gastroesophageal reflux disease  1  9/55 (16.36%)  21
Gastrointestinal disorders - Other  1  8/55 (14.55%)  15
Gastrointestinal pain  1  1/55 (1.82%)  6
Gingival pain  1  2/55 (3.64%)  3
Hemorrhoids  1  1/55 (1.82%)  2
Ileus  1  1/55 (1.82%)  1
Lower gastrointestinal hemorrhage  1  1/55 (1.82%)  1
Mucositis oral  1  24/55 (43.64%)  53
Nausea  1  47/55 (85.45%)  165
Oral hemorrhage  1  2/55 (3.64%)  2
Oral pain  1  8/55 (14.55%)  16
Rectal hemorrhage  1  1/55 (1.82%)  1
Rectal pain  1  4/55 (7.27%)  6
Rectal ulcer  1  1/55 (1.82%)  2
Stomach pain  1  2/55 (3.64%)  4
Tooth discoloration  1  1/55 (1.82%)  1
Toothache  1  3/55 (5.45%)  5
Typhlitis  1  2/55 (3.64%)  2
Vomiting  1  37/55 (67.27%)  84
General disorders   
Chills  1  12/55 (21.82%)  18
Edema face  1  3/55 (5.45%)  4
Edema limbs  1  19/55 (34.55%)  30
Edema trunk  1  1/55 (1.82%)  1
Facial pain  1  1/55 (1.82%)  1
Fatigue  1  47/55 (85.45%)  206
Fever  1  26/55 (47.27%)  46
General disorders and administration site conditions - Other  1  10/55 (18.18%)  18
Infusion related reaction  1  4/55 (7.27%)  5
Injection site reaction  1  1/55 (1.82%)  1
Localized edema  1  3/55 (5.45%)  6
Malaise  1  3/55 (5.45%)  5
Non-cardiac chest pain  1  7/55 (12.73%)  11
Pain  1  5/55 (9.09%)  11
Hepatobiliary disorders   
Cholecystitis  1  1/55 (1.82%)  1
Infections and infestations   
Anorectal infection  1  1/55 (1.82%)  1
Catheter related infection  1  3/55 (5.45%)  3
Device related infection  1  4/55 (7.27%)  4
Enterocolitis infectious  1  1/55 (1.82%)  1
Infections and infestations - Other  1  14/55 (25.45%)  24
Lip infection  1  2/55 (3.64%)  3
Lung infection  1  12/55 (21.82%)  25
Lymph gland infection  1  1/55 (1.82%)  2
Mucosal infection  1  2/55 (3.64%)  2
Paronychia  1  1/55 (1.82%)  1
Pharyngitis  1  1/55 (1.82%)  1
Sepsis  1  3/55 (5.45%)  4
Sinusitis  1  3/55 (5.45%)  4
Skin infection  1  6/55 (10.91%)  6
Soft tissue infection  1  1/55 (1.82%)  1
Tooth infection  1  1/55 (1.82%)  1
Upper respiratory infection  1  3/55 (5.45%)  3
Urinary tract infection  1  3/55 (5.45%)  4
Vaginal infection  1  2/55 (3.64%)  3
Vulval infection  1  1/55 (1.82%)  1
Wound infection  1  1/55 (1.82%)  2
Injury, poisoning and procedural complications   
Bruising  1  10/55 (18.18%)  12
Fall  1  3/55 (5.45%)  3
Injury, poisoning and procedural complications - Other  1  1/55 (1.82%)  1
Postoperative hemorrhage  1  1/55 (1.82%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  18/55 (32.73%)  31
Alanine aminotransferase increased  1  41/55 (74.55%)  107
Alkaline phosphatase increased  1  21/55 (38.18%)  50
Aspartate aminotransferase increased  1  30/55 (54.55%)  72
Blood bilirubin increased  1  19/55 (34.55%)  49
Cardiac troponin I increased  1  1/55 (1.82%)  1
Cholesterol high  1  1/55 (1.82%)  1
Creatinine increased  1  10/55 (18.18%)  25
Ejection fraction decreased  1  1/55 (1.82%)  1
Electrocardiogram QT corrected interval prolonged  1  15/55 (27.27%)  59
Fibrinogen decreased  1  2/55 (3.64%)  2
INR increased  1  22/55 (40.00%)  49
Investigations - Other  1  1/55 (1.82%)  3
Lymphocyte count decreased  1  32/55 (58.18%)  134
Lymphocyte count increased  1  8/55 (14.55%)  11
Neutrophil count decreased  1  51/55 (92.73%)  261
Platelet count decreased  1  51/55 (92.73%)  299
Weight gain  1  3/55 (5.45%)  10
Weight loss  1  12/55 (21.82%)  37
White blood cell decreased  1  40/55 (72.73%)  173
Metabolism and nutrition disorders   
Anorexia  1  27/55 (49.09%)  57
Dehydration  1  1/55 (1.82%)  1
Hypercalcemia  1  5/55 (9.09%)  8
Hyperglycemia  1  40/55 (72.73%)  175
Hyperkalemia  1  10/55 (18.18%)  17
Hypermagnesemia  1  7/55 (12.73%)  7
Hypernatremia  1  5/55 (9.09%)  7
Hypertriglyceridemia  1  1/55 (1.82%)  2
Hyperuricemia  1  14/55 (25.45%)  23
Hypoalbuminemia  1  38/55 (69.09%)  133
Hypocalcemia  1  36/55 (65.45%)  87
Hypoglycemia  1  8/55 (14.55%)  11
Hypokalemia  1  30/55 (54.55%)  64
Hypomagnesemia  1  14/55 (25.45%)  35
Hyponatremia  1  30/55 (54.55%)  76
Hypophosphatemia  1  20/55 (36.36%)  25
Metabolism and nutrition disorders - Other  1  4/55 (7.27%)  36
Tumor lysis syndrome  1  1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders   
Abdominal soft tissue necrosis  1  1/55 (1.82%)  1
Arthralgia  1  6/55 (10.91%)  10
Arthritis  1  3/55 (5.45%)  4
Avascular necrosis  1  1/55 (1.82%)  2
Back pain  1  15/55 (27.27%)  26
Bone pain  1  5/55 (9.09%)  8
Buttock pain  1  3/55 (5.45%)  3
Chest wall pain  1  2/55 (3.64%)  2
Flank pain  1  1/55 (1.82%)  1
Generalized muscle weakness  1  10/55 (18.18%)  16
Muscle weakness lower limb  1  1/55 (1.82%)  1
Musculoskeletal and connective tissue disorder - Other  1  5/55 (9.09%)  14
Myalgia  1  10/55 (18.18%)  16
Neck pain  1  4/55 (7.27%)  4
Pain in extremity  1  8/55 (14.55%)  14
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other  1  1/55 (1.82%)  1
Nervous system disorders   
Akathisia  1  1/55 (1.82%)  1
Amnesia  1  2/55 (3.64%)  2
Ataxia  1  1/55 (1.82%)  2
Concentration impairment  1  1/55 (1.82%)  1
Dizziness  1  15/55 (27.27%)  19
Dysgeusia  1  5/55 (9.09%)  7
Headache  1  31/55 (56.36%)  88
Lethargy  1  2/55 (3.64%)  2
Memory impairment  1  1/55 (1.82%)  1
Nervous system disorders - Other  1  1/55 (1.82%)  1
Peripheral motor neuropathy  1  1/55 (1.82%)  1
Peripheral sensory neuropathy  1  4/55 (7.27%)  8
Tremor  1  1/55 (1.82%)  4
Psychiatric disorders   
Anxiety  1  13/55 (23.64%)  30
Confusion  1  1/55 (1.82%)  1
Delirium  1  1/55 (1.82%)  1
Depression  1  11/55 (20.00%)  24
Hallucinations  1  1/55 (1.82%)  1
Insomnia  1  15/55 (27.27%)  32
Renal and urinary disorders   
Acute kidney injury  1  1/55 (1.82%)  1
Chronic kidney disease  1  5/55 (9.09%)  8
Hematuria  1  4/55 (7.27%)  6
Proteinuria  1  9/55 (16.36%)  13
Renal and urinary disorders - Other  1  1/55 (1.82%)  1
Urinary frequency  1  2/55 (3.64%)  2
Reproductive system and breast disorders   
Breast pain  1  1/55 (1.82%)  1
Genital edema  1  1/55 (1.82%)  1
Menorrhagia  1  3/55 (5.45%)  8
Reproductive system and breast disorders - Other  1  3/55 (5.45%)  4
Vaginal discharge  1  1/55 (1.82%)  1
Vaginal hemorrhage  1  2/55 (3.64%)  3
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  4/55 (7.27%)  4
Apnea  1  1/55 (1.82%)  1
Aspiration  1  1/55 (1.82%)  1
Atelectasis  1  3/55 (5.45%)  3
Bronchopulmonary hemorrhage  1  2/55 (3.64%)  3
Cough  1  22/55 (40.00%)  40
Dyspnea  1  26/55 (47.27%)  52
Epistaxis  1  8/55 (14.55%)  10
Hypoxia  1  5/55 (9.09%)  7
Laryngeal inflammation  1  1/55 (1.82%)  1
Nasal congestion  1  9/55 (16.36%)  14
Pharyngolaryngeal pain  1  2/55 (3.64%)  3
Pleural effusion  1  13/55 (23.64%)  21
Pleuritic pain  1  3/55 (5.45%)  5
Pneumonitis  1  2/55 (3.64%)  6
Productive cough  1  3/55 (5.45%)  3
Pulmonary edema  1  1/55 (1.82%)  2
Respiratory, thoracic and mediastinal disorders - Other  1  5/55 (9.09%)  11
Sinus disorder  1  1/55 (1.82%)  1
Sore throat  1  6/55 (10.91%)  9
Skin and subcutaneous tissue disorders   
Alopecia  1  8/55 (14.55%)  22
Dry skin  1  5/55 (9.09%)  9
Erythema multiforme  1  3/55 (5.45%)  4
Hyperhidrosis  1  2/55 (3.64%)  3
Pain of skin  1  2/55 (3.64%)  2
Palmar-plantar erythrodysesthesia syndrome  1  4/55 (7.27%)  12
Periorbital edema  1  1/55 (1.82%)  1
Photosensitivity  1  1/55 (1.82%)  1
Pruritus  1  8/55 (14.55%)  11
Purpura  1  5/55 (9.09%)  6
Rash acneiform  1  1/55 (1.82%)  3
Rash maculo-papular  1  31/55 (56.36%)  79
Scalp pain  1  1/55 (1.82%)  2
Skin and subcutaneous tissue disorders - Other  1  18/55 (32.73%)  37
Skin ulceration  1  3/55 (5.45%)  3
Vascular disorders   
Flushing  1  1/55 (1.82%)  2
Hematoma  1  5/55 (9.09%)  5
Hypertension  1  14/55 (25.45%)  32
Hypotension  1  14/55 (25.45%)  25
Thromboembolic event  1  2/55 (3.64%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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: Guido Marcucci, M.D.
Organization: The Ohio State University
EMail: Guido.Marcucci@osumc.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01238211     History of Changes
Other Study ID Numbers: NCI-2011-02615
NCI-2011-02615 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000688434
CALGB-10801 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-10801 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2010
First Posted: November 10, 2010
Results First Submitted: July 21, 2014
Results First Posted: August 12, 2014
Last Update Posted: September 24, 2019