Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01893320
Collaborator
Sunesis Pharmaceuticals (Industry)
66
Enrollment
1
Location
1
Arm
89.8
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn if the combination of vosaroxin and decitabine can help to control AML or MDS. The safety of these drugs will also be studied.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1/Phase 2

Detailed Description

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of up to 6 participants will be enrolled in the Phase I portion of the study, and up to 60 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of vosaroxin you receive will depend on when you joined this study. The first group of participants will receive the highest dose level of vosaroxin. If no intolerable side effects are seen, the study will move on to Phase

  1. If intolerable side effects are seen, each new group will receive a lower dose of vosaroxin than the group before it until the most tolerable dose is found.

If you are enrolled in the Phase II portion, you will receive vosaroxin at the highest dose that was tolerated in the Phase I portion.

All participants will receive the same dose level of decitabine.

Study Drug Administration:

You will receive the study drugs in cycles. The study cycles will be 4-12 weeks long, depending on if/how the disease responds to the treatment, how your bone marrow reacts to treatment, and what the doctor thinks is in your best interest.

On Days 1-5 of each study cycle, you will receive decitabine by vein over about 1 hour. On Days 1 and 4 of each cycle, you will also receive vosaroxin by vein over 8-10 minutes, before you receive decitabine. Depending on how the disease responds to the study drugs, the number of days you receive the study drug may change. Your doctor will discuss this with you.

The first 2 cycles are called Induction Cycles. All cycles after that are called Consolidation Cycles. All participants will receive Induction Cycle 1. If the study doctor thinks it is needed, you will also receive Induction Cycle 2. If after that the study doctor thinks it is in your best interest, you will receive up to 5 Consolidation Cycles of treatment.

Study Visits:

On Day 1 of each cycle, you will have a physical exam.

Every week, blood (about 1 tablespoon) will be drawn for routine tests. If at any point you appear to have a response to the study drugs, this blood will then be drawn every 1-2 weeks while you are still receiving the study drugs. If your doctor thinks it is needed, more blood may need to be drawn.

On Day 21 of Cycle 1 (+/- 7 days), then every 4 weeks after that, you will have a bone marrow aspiration and/or biopsy to check the status of the disease. If the doctor thinks it is needed, these may be done more or less often, depending on your response to the study drugs.

Length of Study:

You may receive the study drugs for up to 7 cycles. You will be taken off study if the disease gets worse, intolerable side effects occur, or if the study doctor thinks it is in your best interest.

Your participation in the study will be over after the follow-up period.

End-of-Study Visit:

If you are taken off study or if you leave the study early, you will have an end-of-study visit. At this visit:

Blood (about 2-3 teaspoons) will be drawn for routine tests. If the study doctor thinks it is needed, you will have a bone marrow aspiration.

You will then be contacted during a study visit or called and asked about any side effects you may be having 30 days after the end-of-study visit. This call will last about 5 minutes.

Follow-up:

If you do not leave the study early, you will have follow-up visits and calls for up to 5 years after you stop receiving the study drugs.

Every 4-8 weeks, blood (about 1 tablespoon) will be drawn for routine tests. If you cannot return to the clinic, you may have blood drawn at a clinic close to your home.

Every 3-6 months, you will be contacted during a clinic visit and asked how you are doing. If you cannot make it to the clinic for this visit, you will be called. The phone call should last about 5 minutes.

This is an investigational study. Vosaroxin is not FDA approved or commercially available. It is currently being used for research purposes only. Decitabine has been approved by the FDA for the treatment of MDS, which is a precursor of AML, but has not been approved for the treatment of AML. The use of these drugs in combination is investigational. The study doctor can explain how the drugs are designed to work.

Up to 84 patients will take part in this study. All will be enrolled at MD Anderson.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study of Vosaroxin and Decitabine in Older Patients With Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome
Actual Study Start Date :
Jul 18, 2013
Actual Primary Completion Date :
Jan 11, 2021
Actual Study Completion Date :
Jan 11, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Vosaroxin + Decitabine

The first 6 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5). Following the phase I portion, patients in phase II receive the following induction: Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I.

Drug: Vosaroxin
Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle. Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I.

Drug: Decitabine
Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
Other Names:
  • Dacogen
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum Tolerated Dose (MTD) of Vosaroxin in Combination With Decitabine [21 days]

      Maximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which <33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy. This will define severe and delayed myelosuppression not related to persistent leukemia and likely related to treatment.

    Secondary Outcome Measures

    1. Participants With a Response [21 days]

      A Response is defined as: Complete response (CR) + Complete response without platelet recovery (CRp) + CR with insufficient hematological recovery (platelets or neutrophils (CRi). CR is Neutrophil count 2: 1.0 x 10^9/L, platelet count 2: 100 x 10^9/L and bone marrow aspirate and biopsy: S5% blasts. CRp is same as CR but with Platelets < 100 x 10^/L. CRi is same as CR but platelets < 100 x 10(/L or neutrophils < 1 x 10^9.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Previously untreated AML (>/= 20% blasts). Patients with high-risk MDS (defined as having >/= 10% blasts in the bone marrow) or patients with Chronic Myelomonocytic Leukemia (CMML) (having >/= 10% blasts in the bone marrow) may also be eligible after discussion with Principal Investigator (PI). Prior therapy with hydroxyurea, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is allowed, however prior therapy with chemotherapy agents for the disease under study is not allowed. Patients may have received one dose of cytarabine (up to 2 g/m2) administered at presentation for control of hyperleucocytosis. For patients with prior MDS or CMML who transformed to AML, therapy received for MDS is not considered as prior therapy for AML.

    2. Age >/= 60 years and not candidates for conventional cytotoxic chemotherapy or refuse it; OR patients below the age of 60 years who are considered unfit and/or unable to tolerate standard chemotherapy at the discretion of the treating physician or the principal investigator. "

    3. Eastern Cooperative Oncology Group performance status </= 2.

    4. Adequate hepatic (serum total bilirubin </= 1.5 x upper limit normal (ULN), alanine aminotransferase and/or aspartate transaminase </= 2.5 x ULN) and renal function (creatinine </= 2.0 mg/dL).

    5. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)

    6. Patients must be willing and able to review, understand, and provide written consent before starting therapy.

    7. Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum pregnancy test within 14 days before the start of the treatment. Women of childbearing potential may have a urine pregnancy test, instead of a serum pregnancy test. If either the serum or urine pregnancy test is equivocally negative the patient will be eligible for the protocol. Women of childbearing potential must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment.

    Exclusion Criteria:
    1. New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as active angina pectoris, clinically significant cardiac arrhythmia that requires therapy in the opinion of the treating physician or PI, uncontrolled hypertension (blood pressure > 160 systolic and > 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus in the opinion of the treating physician or PI, or uncontrolled congestive heart failure in the opinion of the treating physician or PI.

    2. Myocardial infarction in the previous 12 weeks (from the start of treatment).

    3. Active and uncontrolled disease/infection as judged by the treating physician

    4. Pregnant or breastfeeding

    5. Known Human Immunodeficiency Virus seropositivity

    6. Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor

    7. Acute promyelocytic leukemia (APL).

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Texas MD Anderson Cancer CenterHoustonTexasUnited States77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • Sunesis Pharmaceuticals

    Investigators

    • Principal Investigator: Naval Daver, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01893320
    Other Study ID Numbers:
    • 2013-0099
    • NCI-2013-01665
    First Posted:
    Jul 9, 2013
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsRecruitment Period: July 2013 to June 2016
    Pre-assignment Detail
    Arm/Group TitlePhase I MTD VosaroxinVosaroxin + Decitabine
    Arm/Group DescriptionThe first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5). Following the phase I portion, patients in phase II receive the following induction: Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I. Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle. Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I. Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
    Period Title: Overall Study
    STARTED759
    COMPLETED759
    NOT COMPLETED00

    Baseline Characteristics

    Arm/Group TitlePhase I MTD VosaroxinVosaroxin + DecitabineTotal
    Arm/Group DescriptionThe first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5). Following the phase I portion, patients in phase II receive the following induction: Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I. Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle. Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I. Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).Total of all reporting groups
    Overall Participants75966
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    2
    28.6%
    9
    15.3%
    11
    16.7%
    >=65 years
    5
    71.4%
    50
    84.7%
    55
    83.3%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    69
    69
    69
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    24
    40.7%
    24
    36.4%
    Male
    7
    100%
    35
    59.3%
    42
    63.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    3
    5.1%
    3
    4.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    3
    5.1%
    3
    4.5%
    White
    7
    100%
    49
    83.1%
    56
    84.8%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    4
    6.8%
    4
    6.1%
    Region of Enrollment (participants) [Number]
    United States
    7
    100%
    59
    100%
    66
    100%

    Outcome Measures

    1. Primary Outcome
    TitleMaximum Tolerated Dose (MTD) of Vosaroxin in Combination With Decitabine
    DescriptionMaximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which <33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy. This will define severe and delayed myelosuppression not related to persistent leukemia and likely related to treatment.
    Time Frame21 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePhase I MTD Vosaroxin
    Arm/Group DescriptionThe first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).
    Measure Participants7
    Number [Mg/m^2]
    70
    2. Secondary Outcome
    TitleParticipants With a Response
    DescriptionA Response is defined as: Complete response (CR) + Complete response without platelet recovery (CRp) + CR with insufficient hematological recovery (platelets or neutrophils (CRi). CR is Neutrophil count 2: 1.0 x 10^9/L, platelet count 2: 100 x 10^9/L and bone marrow aspirate and biopsy: S5% blasts. CRp is same as CR but with Platelets < 100 x 10^/L. CRi is same as CR but platelets < 100 x 10(/L or neutrophils < 1 x 10^9.
    Time Frame21 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitlePhase I MTD VosaroxinVosaroxin + Decitabine
    Arm/Group DescriptionThe first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5). Following the phase I portion, patients in phase II receive the following induction: Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I. Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle. Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I. Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
    Measure Participants759
    Count of Participants [Participants]
    7
    100%
    42
    71.2%

    Adverse Events

    Time FrameUp to 2 years 11 months
    Adverse Event Reporting Description
    Arm/Group TitlePhase I MTD VosaroxinVasoroxin + Decitabine
    Arm/Group DescriptionThe first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5).The first 7 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5). Following the phase I portion, patients in phase II receive the following induction: Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I. Vosaroxin: Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle. Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I. Decitabine: Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
    All Cause Mortality
    Phase I MTD VosaroxinVasoroxin + Decitabine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/7 (0%) 7/59 (11.9%)
    Serious Adverse Events
    Phase I MTD VosaroxinVasoroxin + Decitabine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total6/7 (85.7%) 48/59 (81.4%)
    Blood and lymphatic system disorders
    Febrile Neutropenia3/7 (42.9%) 818/59 (30.5%) 23
    Cardiac disorders
    Myocardial Infarction1/7 (14.3%) 10/59 (0%) 0
    Gastrointestinal disorders
    Abdominal Pain0/7 (0%) 01/59 (1.7%) 1
    Gastrointestinal Disorders - Other0/7 (0%) 01/59 (1.7%) 1
    Ileus0/7 (0%) 01/59 (1.7%) 1
    Mucositis Oral2/7 (28.6%) 24/59 (6.8%) 4
    Nausea0/7 (0%) 01/59 (1.7%) 1
    Proctitis0/7 (0%) 01/59 (1.7%) 1
    Rectal Hemorrhage0/7 (0%) 02/59 (3.4%) 2
    General disorders
    Back Pain0/7 (0%) 01/59 (1.7%) 1
    Edema Face0/7 (0%) 01/59 (1.7%) 1
    Fatigue0/7 (0%) 01/59 (1.7%) 1
    Generalized Weakness0/7 (0%) 01/59 (1.7%) 1
    Multi-Organ Failure0/7 (0%) 01/59 (1.7%) 1
    Non-Cardiac Chest Pain0/7 (0%) 01/59 (1.7%) 1
    Infections and infestations
    Bone Infection0/7 (0%) 01/59 (1.7%) 1
    Catheter Related Infection0/7 (0%) 03/59 (5.1%) 3
    Enterocolitis Infection0/7 (0%) 01/59 (1.7%) 1
    Infection0/7 (0%) 08/59 (13.6%) 10
    Lung Infection2/7 (28.6%) 213/59 (22%) 17
    Pharyngitis0/7 (0%) 02/59 (3.4%) 2
    Sepsis1/7 (14.3%) 111/59 (18.6%) 12
    Skin Infection0/7 (0%) 01/59 (1.7%) 1
    Soft Tissue Infection0/7 (0%) 01/59 (1.7%) 1
    Urinary Tract Infection1/7 (14.3%) 12/59 (3.4%) 2
    Investigations
    Blood Bilirubin Increased0/7 (0%) 02/59 (3.4%) 2
    Metabolism and nutrition disorders
    Dehydration1/7 (14.3%) 12/59 (3.4%) 2
    Hypomagnesemia1/7 (14.3%) 10/59 (0%) 0
    Musculoskeletal and connective tissue disorders
    Bone Pain1/7 (14.3%) 11/59 (1.7%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified0/7 (0%) 01/59 (1.7%) 1
    Nervous system disorders
    Intracranial Hemorrhage0/7 (0%) 01/59 (1.7%) 1
    Stroke0/7 (0%) 01/59 (1.7%) 1
    Syncope0/7 (0%) 01/59 (1.7%) 1
    Psychiatric disorders
    Delirium0/7 (0%) 01/59 (1.7%) 1
    Renal and urinary disorders
    Acute Kidney Injury0/7 (0%) 01/59 (1.7%) 1
    Renal Calculi0/7 (0%) 01/59 (1.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Respiratory Failure0/7 (0%) 03/59 (5.1%) 3
    Respiratory, thoracic and mediastinal disorders0/7 (0%) 01/59 (1.7%) 1
    Other (Not Including Serious) Adverse Events
    Phase I MTD VosaroxinVasoroxin + Decitabine
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total2/7 (28.6%) 19/59 (32.2%)
    Cardiac disorders
    Heart Failure0/7 (0%) 01/59 (1.7%) 1
    Ear and labyrinth disorders
    Hearing Impaired0/7 (0%) 01/59 (1.7%) 1
    Eye disorders
    Conjunctivitis0/7 (0%) 01/59 (1.7%) 1
    Gastrointestinal disorders
    Ileus0/7 (0%) 01/59 (1.7%) 1
    Toothache0/7 (0%) 01/59 (1.7%) 1
    General disorders
    Gait disturbance0/7 (0%) 02/59 (3.4%) 2
    Infections and infestations
    Infection0/7 (0%) 01/59 (1.7%) 1
    Soft Tissue Infection0/7 (0%) 01/59 (1.7%) 1
    Injury, poisoning and procedural complications
    Fall0/7 (0%) 03/59 (5.1%) 3
    Wound Complication0/7 (0%) 01/59 (1.7%) 1
    Investigations
    Alanine Aminotransferase Increased0/7 (0%) 01/59 (1.7%) 1
    Aspartate Aminotransferase Increase0/7 (0%) 01/59 (1.7%) 1
    Blood Bilirubin Increase1/7 (14.3%) 12/59 (3.4%) 2
    Metabolism and nutrition disorders
    Hyperglycemia0/7 (0%) 01/59 (1.7%) 1
    Hyperkalemia0/7 (0%) 01/59 (1.7%) 1
    Hypernatremia0/7 (0%) 01/59 (1.7%) 1
    Hypocalcemia0/7 (0%) 01/59 (1.7%) 1
    Hypokalemia0/7 (0%) 04/59 (6.8%) 5
    Hyponatremia0/7 (0%) 01/59 (1.7%) 1
    Hypophosphatemia0/7 (0%) 01/59 (1.7%) 1
    Musculoskeletal and connective tissue disorders
    Arthritis0/7 (0%) 01/59 (1.7%) 1
    Nervous system disorders
    Dysartharia0/7 (0%) 01/59 (1.7%) 1
    Hallucinations0/7 (0%) 01/59 (1.7%) 1
    Seizure0/7 (0%) 01/59 (1.7%) 1
    Renal and urinary disorders
    Acute Kidney Injury1/7 (14.3%) 11/59 (1.7%) 1
    Urine discoloration0/7 (0%) 01/59 (1.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Hoarsness0/7 (0%) 01/59 (1.7%) 1
    Postnasal drip0/7 (0%) 01/59 (1.7%) 1
    Skin and subcutaneous tissue disorders
    Burn0/7 (0%) 01/59 (1.7%) 1
    Erythema multiforme0/7 (0%) 01/59 (1.7%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT 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/TitleNaval Daver MD, Associate Professor
    OrganizationThe University of Texas MD Anderson Cancer Center
    Phone713-794-4392
    EmailNDaver@mdanderson.org
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01893320
    Other Study ID Numbers:
    • 2013-0099
    • NCI-2013-01665
    First Posted:
    Jul 9, 2013
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Jan 1, 2022