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Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01907815
Recruitment Status : Terminated (Lack of efficacy.)
First Posted : July 25, 2013
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
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 Recurrent Adult Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions Drug: Akt Inhibitor GSK2141795
Other: Laboratory Biomarker Analysis
Drug: Trametinib
Enrollment 24
Recruitment Details Recruitment Period: October 9, 2013 to January 25, 2016. All recruitment done within medical clinic settings at The University of Texas MD Anderson Cancer Center, The University of Chicago and The University of Maryland Greenebaum Cancer Center.
Pre-assignment Details Study was terminated early, stopped due to lack of efficacy.
Arm/Group Title Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Hide Arm/Group Description Trametinib 2.0 mg orally once daily (PO QD) and Akt inhibitor GSK2141795 25 mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Period Title: Overall Study
Started 17 7
Completed 16 7
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg Total
Hide Arm/Group Description Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28. Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28. Total of all reporting groups
Overall Number of Baseline Participants 17 7 24
Hide Baseline Analysis Population Description
One participant withdrew prior to treatment so is included in baseline demographics but not in study analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 7 participants 24 participants
68
(22 to 80)
69
(61 to 80)
69
(22 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 7 participants 24 participants
Female
6
  35.3%
3
  42.9%
9
  37.5%
Male
11
  64.7%
4
  57.1%
15
  62.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 17 participants 7 participants 24 participants
17
 100.0%
7
 100.0%
24
 100.0%
1.Primary Outcome
Title Complete Response Rate (CRR, Defined as CR+CRp) Assessed by AML 2003 Response Criteria
Hide Description Proportion of participants achieving complete remission (CR) or CR with incomplete recovery of platelets (CRp) as best response within 4 cycles of therapy. Complete Response (CR): Disappearance all clinical &/or radiologic evidence of disease. Neutrophil count ≥ 1.0x10^9/L; Platelet count ≥ 100x109/L; Normal bone marrow differential (≤ 5% blasts); No extra-medullary leukemia. Complete Remission without Platelet Recovery (CRp): Peripheral blood & bone marrow results as for CR, but platelet counts of < 100x10^9/L. Partial Remission (PR): Blood count recovery as for CR, but decrease of at least 50% in % marrow blasts to >5% to 25% in bone marrow aspirate. Morphologic leukemia-free state: Normal marrow differential (<5% blasts); neutrophil & platelet counts not considered.95% confidence interval will be estimated for the combination regimen.
Time Frame First four cycles (16 weeks) of therapy, with evaluation after one full cycle of therapy (28 days) and up to 16 weeks for response
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant in first cohort withdrew prior to treatment therefore excluded from study analysis.
Arm/Group Title Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Hide Arm/Group Description:
Trametinib 2.0 mg PO QD & GSK2141795 25 mg PO QD on days 1-28.
Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
Overall Number of Participants Analyzed 16 7
Measure Type: Number
Unit of Measure: percentage of participants
0 0
2.Secondary Outcome
Title Most Frequently Reported Adverse Events (AE)
Hide Description National Cancer Institute (NCI) published standardized definitions for adverse events (AEs), known as Common Terminology Criteria for Adverse Events (CTCAE), to describe the severity of organ toxicity for those receiving cancer therapy. Toxicity data is summarized by number of incidents experienced while participants were on study using most frequently reported AEs regardless of grade or relatedness as assessed by CTCAE version 4.0. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved. Death (Grade 5) is used for some of the criteria to denote a fatality. For full adverse event reporting see Adverse Event Section. Data collection over first four cycles (16 weeks) of therapy, with evaluation after full cycle of therapy (28 days), continuing AE collection until 28 days following last study drug dose.
Time Frame AE collected continuously over 28-day cycles and up to 28 days after last dose of study drug.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant of the 17 registered in first cohort (Trametinib 2.0) withdrew without treatment and is excluded from adverse event reporting.
Arm/Group Title Trametinib 2.0 + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Hide Arm/Group Description:
Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
Overall Number of Participants Analyzed 16 7
Measure Type: Number
Unit of Measure: events
Anemia 15 3
Diarrhea 16 3
Fatigue 11 6
Fever 13 3
Nausea 8 3
Rash maculo-papular 6 5
Mucositis oral 5 3
Vomiting 7 1
3.Secondary Outcome
Title Overall Survival of Participants Achieving CR/CRp
Hide Description Estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Time Frame Up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants achieved CR/CRp therefore analysis not available.
Arm/Group Title Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Hide Arm/Group Description:
Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression Free Survival of Participants Achieving CR/CRp
Hide Description Estimated disease-free survival period using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.
Time Frame Up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants achieved CR/CRp therefore analysis not available.
Arm/Group Title Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Hide Arm/Group Description:
Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Progression for Participants Achieving CR/CRp
Hide Description Time to Progression (TTP) is defined as the length of time from the start of treatment to disease progression as measured in days for participants with complete response.
Time Frame Up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Outcome data were not collected and the Outcome will never be analyzed.
Arm/Group Title Trametinib 2.0 + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Hide Arm/Group Description:
Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Maximum Percentage Change in Total and Phospho-proteins
Hide Description Change in total and phospho-proteins assessed by densitometric quantitative data by western blot analysis, or mean fluorescent intensities by flow cytometry and will be assessed for each patient for all time points and graphically plotted for each dose level.
Time Frame Baseline to 12 weeks post therapy
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Percentage Change in Cellular Proteins
Hide Description The 95% confidence interval will be assessed.
Time Frame Baseline to day 28 post treatment
Outcome Measure Data Not Reported
Time Frame Adverse events collected continuously over a 28-day cycle schedule and up to 28 days after last dose of study drug.
Adverse Event Reporting Description One participant in first cohort withdrew prior to treatment therefore excluded from all study analysis.
 
Arm/Group Title Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Hide Arm/Group Description Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28. Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
All-Cause Mortality
Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/16 (68.75%)      6/7 (85.71%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/16 (6.25%)  2 1/7 (14.29%)  1
Leukocytosis  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Cardiac disorders     
Atrial fibrillation  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Carotid Stent placed  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Myocardial infarction  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  2/16 (12.50%)  2 0/7 (0.00%)  0
Gastric hemorrhage  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Gastric perforation  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Lower gastrointestinal hemorrhage Gastric Ulcer  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Mucositis oral  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Nausea  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Rectal pain  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Vomiting  1  1/16 (6.25%)  1 0/7 (0.00%)  0
General disorders     
Death NOS  1  3/16 (18.75%)  3 0/7 (0.00%)  0
Fever  1  2/16 (12.50%)  5 0/7 (0.00%)  0
Infections and infestations     
Catheter related infection  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Lung infection  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Sepsis  1  1/16 (6.25%)  1 2/7 (28.57%)  2
Injury, poisoning and procedural complications     
Fall  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Alkaline phosphatase increased  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Creatinine increased  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Ejection fraction decreased  1  1/16 (6.25%)  1 1/7 (14.29%)  1
Metabolism and nutrition disorders     
Dehydration  1  1/16 (6.25%)  1 1/7 (14.29%)  1
Tumor lysis syndrome  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Nervous system disorders     
Syncope  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Psychiatric disorders     
Confusion  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Reproductive system and breast disorders     
Dyspnea  1  2/16 (12.50%)  2 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchial infection  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Bronchopulmonary hemorrhage  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  0/16 (0.00%)  0 1/7 (14.29%)  1
Skin infection  1  1/16 (6.25%)  1 0/7 (0.00%)  0
Vascular disorders     
Hypotension  1  3/16 (18.75%)  4 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 1.5 mg + GSK2141795 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/16 (100.00%)      6/7 (85.71%)    
Blood and lymphatic system disorders     
Anemia  2  5/16 (31.25%)  15 2/7 (28.57%)  3
Febrile neutropenia  2  4/16 (25.00%)  5 1/7 (14.29%)  1
Leukocytosis  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Thrombotic thrombocytopenic purpura  2  0/16 (0.00%)  0 3/7 (42.86%)  4
Cardiac disorders     
Acute coronary syndrome  2  1/16 (6.25%)  1 1/7 (14.29%)  1
Atrial fibrillation  2  0/16 (0.00%)  0 2/7 (28.57%)  4
Cardiac arrest  2  0/16 (0.00%)  0 2/7 (28.57%)  2
Cardiac disorders - Carotid Stent placed  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Chest pain - cardiac  2  1/16 (6.25%)  2 0/7 (0.00%)  0
Myocardial infarction  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Ear and labyrinth disorders     
External ear inflammation  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Endocrine disorders     
Hypothyroidism  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Eye disorders     
Eye disorders - (Other)  2  2/16 (12.50%)  2 0/7 (0.00%)  0
Eye infection  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Eye pain  2  0/16 (0.00%)  0 1/7 (14.29%)  2
Eyelid function disorder  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders     
Abdominal pain  1  3/16 (18.75%)  3 1/7 (14.29%)  1
Colitis  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Constipation  2  1/16 (6.25%)  1 1/7 (14.29%)  1
Diarrhea  2  10/16 (62.50%)  14 3/7 (42.86%)  3
Dyspepsia  2  2/16 (12.50%)  2 0/7 (0.00%)  0
Esophageal necrosis  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Gastric hemorrhage  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Gastric perforation  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Gastric ulcer  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Gastroesophageal reflux disease  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Ileus  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Lower gastrointestinal hemorrhage Gastric Ulcer  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Mucositis oral  2  4/16 (25.00%)  5 1/7 (14.29%)  2
Nausea  2  6/16 (37.50%)  7 3/7 (42.86%)  3
Oral pain  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Rectal pain  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Upper gastrointestinal hemorrhage  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Vomiting  2  5/16 (31.25%)  6 1/7 (14.29%)  1
General disorders     
Edema limbs  2  2/16 (12.50%)  2 1/7 (14.29%)  1
Fatigue  2  8/16 (50.00%)  11 5/7 (71.43%)  6
Fever  2  5/16 (31.25%)  8 3/7 (42.86%)  3
Gait disturbance  2  0/16 (0.00%)  0 1/7 (14.29%)  1
General disorders and administration site conditions - (Other)  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Lymphocyte count decreased  2  3/16 (18.75%)  3 0/7 (0.00%)  0
Malaise  2  0/16 (0.00%)  0 3/7 (42.86%)  3
Pain  2  2/16 (12.50%)  2 2/7 (28.57%)  2
Hepatobiliary disorders     
Cholecystitis  2  1/16 (6.25%)  3 0/7 (0.00%)  0
Infections and infestations     
Catheter related infection  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations - (Other)  2  2/16 (12.50%)  3 0/7 (0.00%)  0
Lung infection  2  2/16 (12.50%)  2 0/7 (0.00%)  0
Sepsis  2  1/16 (6.25%)  1 2/7 (28.57%)  2
Wound infection  2  1/16 (6.25%)  1 1/7 (14.29%)  1
Injury, poisoning and procedural complications     
Fall  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Injury, poisoning and procedural complications - (Other)  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Investigations     
Alanine aminotransferase increased  2  4/16 (25.00%)  4 0/7 (0.00%)  0
Alkaline phosphatase increased  2  3/16 (18.75%)  3 0/7 (0.00%)  0
Aspartate aminotransferase increased  2  3/16 (18.75%)  4 0/7 (0.00%)  0
Creatinine increased  2  1/16 (6.25%)  1 1/7 (14.29%)  1
Ejection fraction decreased  2  0/16 (0.00%)  0 1/7 (14.29%)  1
INR increased  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Neutrophil count decreased  2  3/16 (18.75%)  3 1/7 (14.29%)  1
Platelet count decreased  2  4/16 (25.00%)  4 0/7 (0.00%)  0
Weight loss  2  2/16 (12.50%)  2 0/7 (0.00%)  0
White blood cell decreased  2  3/16 (18.75%)  5 1/7 (14.29%)  1
Metabolism and nutrition disorders     
Anorexia  2  3/16 (18.75%)  3 2/7 (28.57%)  2
Dehydration  2  1/16 (6.25%)  1 2/7 (28.57%)  2
Hypermagnesemia  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Hyperuricemia  2  3/16 (18.75%)  3 1/7 (14.29%)  1
Hypoalbuminemia  2  3/16 (18.75%)  5 0/7 (0.00%)  0
Hypocalcemia  2  3/16 (18.75%)  3 0/7 (0.00%)  0
Hypokalemia  2  1/16 (6.25%)  1 1/7 (14.29%)  2
Hypomagnesemia  2  4/16 (25.00%)  4 2/7 (28.57%)  2
Hyponatremia  2  2/16 (12.50%)  2 0/7 (0.00%)  0
Hypophosphatemia  2  1/16 (6.25%)  1 1/7 (14.29%)  1
Iron overload  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Tumor lysis syndrome  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Back pain  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Bone pain  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Joint range of motion decreased  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Muscle weakness upper limb  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Pain in extremity  2  1/16 (6.25%)  1 2/7 (28.57%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - (Other)  2  2/16 (12.50%)  2 0/7 (0.00%)  0
Nervous system disorders     
Dizziness  2  1/16 (6.25%)  1 2/7 (28.57%)  2
Dysgeusia  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Headache  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Seizure  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Syncope  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Psychiatric disorders     
Anxiety  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Confusion  2  2/16 (12.50%)  2 0/7 (0.00%)  0
Delirium  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Depression  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Renal and urinary disorders     
Acute kidney injury  2  2/16 (12.50%)  3 1/7 (14.29%)  3
Chronic kidney disease  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Hematuria  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Renal and urinary disorders - (Other)  2  1/16 (6.25%)  1 1/7 (14.29%)  1
Urinary tract pain  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Reproductive system and breast disorders     
Dyspnea  2  3/16 (18.75%)  3 2/7 (28.57%)  2
Hot flashes  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Aspiration  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Bronchial infection  2  1/16 (6.25%)  1 1/7 (14.29%)  1
Bronchopulmonary hemorrhage  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Cough  2  0/16 (0.00%)  0 2/7 (28.57%)  2
Epistaxis  2  1/16 (6.25%)  1 3/7 (42.86%)  3
Nasal congestion  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Pleural effusion  2  1/16 (6.25%)  1 1/7 (14.29%)  1
Pneumonitis  2  0/16 (0.00%)  0 1/7 (14.29%)  1
Sore throat  2  2/16 (12.50%)  2 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Purpura  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Rash acneiform  2  1/16 (6.25%)  2 0/7 (0.00%)  0
Rash maculo-papular  2  5/16 (31.25%)  6 3/7 (42.86%)  4
Skin infection  2  1/16 (6.25%)  1 0/7 (0.00%)  0
Vascular disorders     
Hypertension  2  2/16 (12.50%)  3 0/7 (0.00%)  0
Hypotension  2  3/16 (18.75%)  4 1/7 (14.29%)  1
Thromboembolic event  2  2/16 (12.50%)  2 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
2
Term from vocabulary, CTCAE (4.0)
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: Nitin Jain, MD, Assistant Professor, Leukemia
Organization: The University of Texas MD Anderson Cancer Center
Phone: 713-792-7734
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01907815     History of Changes
Other Study ID Numbers: NCI-2013-01354
NCI-2013-01354 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI 9443
2013-0001 ( Other Identifier: MD Anderson Cancer Center )
9443 ( Other Identifier: CTEP )
N01CM39 ( Other Grant/Funding Number: Federal Funding, NIH )
N01CM71 ( Other Grant/Funding Number: Federal Funding, NIH )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2013
First Posted: July 25, 2013
Results First Submitted: August 2, 2017
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018