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Trial record 24 of 253 for:    IDARUBICIN

E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT01692197
Recruitment Status : Completed
First Posted : September 25, 2012
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
Eisai Inc.
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: E7070
Drug: Idarubicin
Drug: Cytarabine
Drug: Dexamethasone
Enrollment 43

Recruitment Details Recruitment Period: 2/2013 to 06/2014
Pre-assignment Details Of the 43 participants registered, three never received the study medication.
Arm/Group Title E7070 and Idarubicin and Cytarabine
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E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:

Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).

Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).

Period Title: Overall Study
Started 43
Completed 40
Not Completed 3
Reason Not Completed
Failed Screening             3
Arm/Group Title E7070 and Idarubicin and Cytarabine
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E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:

Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).

Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).

Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  58.1%
>=65 years
18
  41.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants
63
(25 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
21
  48.8%
Male
22
  51.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  14.0%
White
36
  83.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
1.Primary Outcome
Title Overall Response
Hide Description Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.
Time Frame 2 cycles (60 days)
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Hide Analysis Population Description
Thirty seven patients are evaluable.
Arm/Group Title E7070 and Idarubicin and Cytarabine
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E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:

Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).

Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).

Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
11
  29.7%
2.Secondary Outcome
Title Disease-free Survival
Hide Description Time from date of treatment start until the date of first objective documentation of disease-relapse.
Time Frame Up to 5 years
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Hide Analysis Population Description
Thirty seven patients are evaluable.
Arm/Group Title E7070 + Idarubicin + Cytarabine
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E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.

E7070: 400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.

Idarubicin: 8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).

Cytarabine: 1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).

Dexamethasone: 10 mg by vein daily for 3 - 4 days with cytarabine.

Overall Number of Participants Analyzed 37
Median (Full Range)
Unit of Measure: months
1.7
(1 to 42)
3.Secondary Outcome
Title Duration of Response
Hide Description Response date to loss of response or last follow up.
Time Frame Up to 5 years
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Hide Analysis Population Description
Thirty seven patients are evaluable.
Arm/Group Title E7070 and Idarubicin and Cytarabine
Hide Arm/Group Description:

E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:

Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).

Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).

Overall Number of Participants Analyzed 37
Median (Full Range)
Unit of Measure: months
6.7
(1 to 13)
4.Secondary Outcome
Title Overall Survival
Hide Description Time from date of treatment start until date of death due to any cause or last follow-up.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Thirty seven patients are evaluable.
Arm/Group Title E7070 and Idarubicin and Cytarabine
Hide Arm/Group Description:

E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:

Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).

Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).

Overall Number of Participants Analyzed 37
Median (Full Range)
Unit of Measure: months
5.1
(1 to 42)
Time Frame Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title E7070 and Idarubicin and Cytarabine
Hide Arm/Group Description

E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:

Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age ≥ 60 years).

Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).

All-Cause Mortality
E7070 and Idarubicin and Cytarabine
Affected / at Risk (%)
Total   11/40 (27.50%)    
Show Serious Adverse Events Hide Serious Adverse Events
E7070 and Idarubicin and Cytarabine
Affected / at Risk (%) # Events
Total   30/40 (75.00%)    
Blood and lymphatic system disorders   
Intracranial Hemorrhage  1  1/40 (2.50%)  1
Pulmonary edema  1  1/40 (2.50%)  1
Thromboembolic event  1  1/40 (2.50%)  1
Cardiac disorders   
Atrial Fibrillation  1  1/40 (2.50%)  2
Cardiac Arrest  1  1/40 (2.50%)  1
Chest Pain  1  1/40 (2.50%)  1
Heart Failure  1  1/40 (2.50%)  1
Hypotension  1  1/40 (2.50%)  1
General disorders   
Allergic Reaction  1  1/40 (2.50%)  1
Back Pain  1  1/40 (2.50%)  1
Bone Marrow Hypocellular  1  1/40 (2.50%)  1
Bone Pain  1  1/40 (2.50%)  1
Death  1  2/40 (5.00%)  2
Fall  1  1/40 (2.50%)  1
Fatigue  1  1/40 (2.50%)  1
Fever  1  1/40 (2.50%)  1
Multi-Organ Failure  1  1/40 (2.50%)  1
Infections and infestations   
Infective Endocarditis  1  1/40 (2.50%)  1
Febrile Neutropenia  1  14/40 (35.00%)  18
Joint Infection  1  1/40 (2.50%)  2
Lung Infection  1  11/40 (27.50%)  15
Pelvic Infection  1  1/40 (2.50%)  1
Sepsis  1  9/40 (22.50%)  10
Skin Infection  1  3/40 (7.50%)  3
Upper Respiratory Infection  1  1/40 (2.50%)  1
Wound Infection  1  1/40 (2.50%)  1
Investigations   
Injection Site Reaction  1  1/40 (2.50%)  1
Nervous system disorders   
Syncope  1  1/40 (2.50%)  1
Renal and urinary disorders   
Hematuria  1  1/40 (2.50%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/40 (2.50%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E7070 and Idarubicin and Cytarabine
Affected / at Risk (%) # Events
Total   38/40 (95.00%)    
Blood and lymphatic system disorders   
Edema  1  14/40 (35.00%)  16
Epistaxis  1  3/40 (7.50%)  3
Hematoma  1  2/40 (5.00%)  2
Cardiac disorders   
Atrial Fibrillation  1  3/40 (7.50%)  3
Increased Cardiac Troponin I  1  2/40 (5.00%)  2
Chest Pain  1  3/40 (7.50%)  3
Hypertension  1  2/40 (5.00%)  6
Hypotension  1  5/40 (12.50%)  5
Sinus Tachycardia  1  5/40 (12.50%)  5
Eye disorders   
Eye Disorders  1  2/40 (5.00%)  2
Gastrointestinal disorders   
Anorexia  1  11/40 (27.50%)  11
Constipation  1  13/40 (32.50%)  16
Dehydration  1  3/40 (7.50%)  3
Diarrhea  1  17/40 (42.50%)  17
Dry Mouth  1  2/40 (5.00%)  2
Dysgeusia  1  4/40 (10.00%)  4
Gastroesophageal reflux disease  1  2/40 (5.00%)  2
Gastrointestinal disorders  1  8/40 (20.00%)  11
Hemorrhoids  1  2/40 (5.00%)  2
Hiccups  1  3/40 (7.50%)  3
Oral Mucositis  1  3/40 (7.50%)  3
Nausea  1  21/40 (52.50%)  26
Sore Throat  1  2/40 (5.00%)  2
Vomiting  1  9/40 (22.50%)  12
General disorders   
Pain  1  6/40 (15.00%)  7
Chills  1  2/40 (5.00%)  2
Dizziness  1  7/40 (17.50%)  7
Fatigue  1  16/40 (40.00%)  17
Fever  1  8/40 (20.00%)  10
Headache  1  7/40 (17.50%)  8
Insomnia  1  6/40 (15.00%)  6
Lethargy  1  2/40 (5.00%)  2
malaise  1  3/40 (7.50%)  3
Nasal Congestion  1  2/40 (5.00%)  2
Infections and infestations   
Neutropenic Fever  1  10/40 (25.00%)  13
Metabolism and nutrition disorders   
Increased Alanine Aminotransferase  1  9/40 (22.50%)  15
Increased Alkaline Phosphatase  1  6/40 (15.00%)  12
Increased Aspartate Aminotransferase  1  8/40 (20.00%)  11
Hyperbilirubinemia  1  14/40 (35.00%)  28
Increased Creatinine  1  9/40 (22.50%)  12
Hypercalcemia  1  2/40 (5.00%)  2
Hyperglycemia  1  13/40 (32.50%)  29
Hyperkalemia  1  4/40 (10.00%)  6
Hypernatremia  1  3/40 (7.50%)  3
Hypoalbuminemia  1  10/40 (25.00%)  33
Hypocalcemia  1  12/40 (30.00%)  23
Hypokalemia  1  17/40 (42.50%)  33
Hypomagnesemia  1  16/40 (40.00%)  20
Hyponatremia  1  10/40 (25.00%)  20
Hypophosphatemia  1  10/40 (25.00%)  20
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/40 (5.00%)  3
Nervous system disorders   
Agitation  1  2/40 (5.00%)  2
Anxiety  1  2/40 (5.00%)  2
Confusion  1  4/40 (10.00%)  4
Depression  1  3/40 (7.50%)  3
Hallucinations  1  3/40 (7.50%)  3
Renal and urinary disorders   
Acute Kidney injury  1  2/40 (5.00%)  2
Urinary Retention  1  2/40 (5.00%)  3
Respiratory, thoracic and mediastinal disorders   
Cough  1  7/40 (17.50%)  7
Dyspnea  1  11/40 (27.50%)  11
Hypoxia  1  3/40 (7.50%)  3
Pleural Effusion  1  4/40 (10.00%)  4
Respiratory Failure  1  2/40 (5.00%)  2
Respiratory disorders  1  3/40 (7.50%)  4
Wheezing  1  2/40 (5.00%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  2/40 (5.00%)  2
Skin and Subcutaneous tissue disorders  1  13/40 (32.50%)  14
Surgical and medical procedures   
Surgical and Medical Procedures  1  3/40 (7.50%)  3
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Borthakur,Gautam MD
Organization: UT MD Anderson Cancer Center
Phone: 713-563-1586
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01692197     History of Changes
Other Study ID Numbers: 2009-0570
NCI-2012-02065 ( Registry Identifier: NCI CTRP )
First Submitted: September 20, 2012
First Posted: September 25, 2012
Results First Submitted: June 4, 2018
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018