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Trial record 14 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT01254890
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Collaborators:
Bayer
Onyx Therapeutics, Inc.
Celgene
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: Azacitidine
Drug: Sorafenib
Enrollment 60
Recruitment Details Recruitment Period: January 11, 2011 to February 4, 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Phase I: Azacitidine + Sorafenib Phase II: Azacitidine + 400 mg Sorafenib
Hide Arm/Group Description Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle. Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
Period Title: Overall Study
Started 3 57
Completed 2 47
Not Completed 1 10
Reason Not Completed
Ineligible             0             3
Withdrawal by Subject             1             2
Disease Progression             0             5
Arm/Group Title Phase I: Azacitidine + Sorafenib Phase II: Azacitidine + 400 Sorafenib Total
Hide Arm/Group Description Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle. Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle. Total of all reporting groups
Overall Number of Baseline Participants 3 57 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 57 participants 60 participants
73
(40 to 87)
64
(20 to 81)
64
(20 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 57 participants 60 participants
Female
1
  33.3%
27
  47.4%
28
  46.7%
Male
2
  66.7%
30
  52.6%
32
  53.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 57 participants 60 participants
3 57 60
1.Primary Outcome
Title Phase I: Maximum Tolerated Dose (MTD) of Sorafenib Given With Azacitidine
Hide Description MTD is defined as highest dose level in which 6 patients treated with at most 1 experiencing a dose limiting toxicity (DLT) during 1st cycle. One cycle of therapy is 7 days of azacitidine (AZA) and 28 days of sorafenib. Starting dose of Sorafenib is 200 mg twice a day azacitidine
Time Frame 28 day cycle
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azacitidine + Sorafenib
Hide Arm/Group Description:
Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: mg/twice daily
400
2.Secondary Outcome
Title Phase II: Number of Participants With Response
Hide Description Response according to International Working Group response criteria for Acute myeloid leukemia (AML) (JCO 2003; 21: 4642-9): CR defined by presence of <5% blasts in the bone marrow (BM), with >1 X 10^9/L neutrophils and >100 x 10^9/L platelets in the peripheral blood (PB) with no detectable extramedullary disease. Participants who met the above criteria but had neutrophil or platelet counts less than the stated values were considered to have achieved CRi (CR with incomplete recovery of PB counts) or CR with incomplete platelet recovery (CRp) if CR but platelets < 100 x 10^9/L but ≥ 50 x 10^9/L and platelet transfusion independent. Partial response (PR) required all of the hematologic values for a CR but with a decrease of >/= 50% in the percentage of blasts to 5% to 25% in the BM aspirate.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Nine participants were not evaluable for response.
Arm/Group Title Azacitidine + Sorafenib
Hide Arm/Group Description:
Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 8
Complete Remission Without Platelet Recovery (CRi) 10
Partial Response 1
Complete Response (CRp) 6
No Response 23
Time Frame Adverse events were collected from the time of informed consent to discontinuation of treatment, up to 1 year. Total study period was 3 years and 11 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I: Azacitidine + Sorafenib Phase II: Azacitidine + Sorafenib
Hide Arm/Group Description Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle. Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 400 mg orally twice a day for 28 Day cycle.
All-Cause Mortality
Phase I: Azacitidine + Sorafenib Phase II: Azacitidine + Sorafenib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: Azacitidine + Sorafenib Phase II: Azacitidine + Sorafenib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/57 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I: Azacitidine + Sorafenib Phase II: Azacitidine + Sorafenib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      51/57 (89.47%)    
Blood and lymphatic system disorders     
Neutrophils  1  0/3 (0.00%)  0 13/57 (22.81%)  13
Platelets  1  0/3 (0.00%)  0 6/57 (10.53%)  6
Hemoglobin  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Edema - Limb  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Cardiac disorders     
Hypertension  1  1/3 (33.33%)  1 0/57 (0.00%)  0
Supraventricular Arrhythmia  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Cardiac General-Other  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Eye disorders     
Blurred Vision  1  0/3 (0.00%)  0 2/57 (3.51%)  2
Dry Eye  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Gastrointestinal disorders     
Diarrhea  1  1/3 (33.33%)  1 15/57 (26.32%)  15
Dysphagia  1  1/3 (33.33%)  1 0/57 (0.00%)  0
Constipation  1  0/3 (0.00%)  0 5/57 (8.77%)  5
Mucositis (clinical exam)  1  0/3 (0.00%)  0 2/57 (3.51%)  2
Nausea  1  0/3 (0.00%)  0 13/57 (22.81%)  13
Anorexia  1  0/3 (0.00%)  0 6/57 (10.53%)  6
Typhlitis  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Vomiting  1  0/3 (0.00%)  0 6/57 (10.53%)  6
Mucositis (functional/symptomatic)  1  0/3 (0.00%)  0 3/57 (5.26%)  3
Flatulence  1  0/3 (0.00%)  0 1/57 (1.75%)  1
General disorders     
Fatigue  1  2/3 (66.67%)  2 25/57 (43.86%)  25
Pain  1  0/3 (0.00%)  0 4/57 (7.02%)  4
Weight Loss  1  0/3 (0.00%)  0 4/57 (7.02%)  4
Infections and infestations     
Febrile Neutropenia  1  1/3 (33.33%)  1 13/57 (22.81%)  14
Infection (documented clinically)  1  0/3 (0.00%)  0 26/57 (45.61%)  62
Infection with normal ANC  1  0/3 (0.00%)  0 7/57 (12.28%)  8
Infection - Other  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Colitis  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Metabolism and nutrition disorders     
Alanine Aminotransferase  1  2/3 (66.67%)  2 19/57 (33.33%)  20
Aspartate Aminotransferase  1  2/3 (66.67%)  2 22/57 (38.60%)  22
Bilirubin  1  3/3 (100.00%)  3 28/57 (49.12%)  28
Hyperuricemia  1  1/3 (33.33%)  1 0/57 (0.00%)  0
Creatinine  1  1/3 (33.33%)  1 12/57 (21.05%)  12
Metabolic/Lab  1  1/3 (33.33%)  1 0/57 (0.00%)  0
Alkaline Phosphatase  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Musculoskeletal and connective tissue disorders     
Muscle Weakness  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Nervous system disorders     
Confusion  1  1/3 (33.33%)  1 0/57 (0.00%)  0
Irritability  1  1/3 (33.33%)  1 0/57 (0.00%)  0
Neuropathy - Sensory  1  0/3 (0.00%)  0 2/57 (3.51%)  2
Dizziness  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Mental Status  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Syncope  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Seizure  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/3 (33.33%)  1 0/57 (0.00%)  0
Dyspnea  1  1/3 (33.33%)  1 7/57 (12.28%)  7
Pleural Effusion  1  1/3 (33.33%)  1 1/57 (1.75%)  1
Pulmonary - Other  1  1/3 (33.33%)  1 0/57 (0.00%)  0
Voice Changes  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Skin and subcutaneous tissue disorders     
Rash  1  0/3 (0.00%)  0 14/57 (24.56%)  14
Hand-Foot  1  0/3 (0.00%)  0 6/57 (10.53%)  6
Pruritus  1  0/3 (0.00%)  0 3/57 (5.26%)  3
Dry Skin  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Vascular disorders     
CNS Hemorrhage  1  0/3 (0.00%)  0 1/57 (1.75%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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: Farhad Ravandi-Kashani, Professor, Leukemia Department
Organization: University of Texas (UT) MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01254890     History of Changes
Other Study ID Numbers: 2010-0511
NCI-2011-00257 ( Registry Identifier: NCI CTRP )
First Submitted: December 3, 2010
First Posted: December 7, 2010
Results First Submitted: March 31, 2016
Results First Posted: May 6, 2016
Last Update Posted: May 6, 2016