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Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00607997
First received: January 23, 2008
Last updated: May 25, 2017
Last verified: May 2017
Results First Received: March 27, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Leukemia
Acute Disease
Acute Myeloid Leukemia
Nonlymphocytic Leukemia
Myelodysplastic Syndromes
Intervention: Drug: vosaroxin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
Schedule C: 72 mg/m2 on Days 1 and 4 Schedule C (implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
Schedule C: 90 mg/m2 on Days 1 and 4 Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.

Participant Flow:   Overall Study
    Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15   Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8   Schedule C: 72 mg/m2 on Days 1 and 4   Schedule C: 90 mg/m2 on Days 1 and 4
STARTED   29   35   29   20 
COMPLETED   2   8   5   4 
NOT COMPLETED   27   27   24   16 
Lack of Efficacy                6                20                14                10 
Death                8                5                2                5 
Adverse Event                3                1                2                0 
Physician Decision                4                1                0                0 
Relapse, recurrent illness                4                0                2                0 
Other without explanation                2                0                4                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I.
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II.
Schedule C: 72 mg/m2 on Days 1 and 4 Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose
Schedule C: 90 mg/m2 on Days 1 and 4 Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4.
Total Total of all reporting groups

Baseline Measures
   Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15   Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8   Schedule C: 72 mg/m2 on Days 1 and 4   Schedule C: 90 mg/m2 on Days 1 and 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   35   29   20   113 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.1  (6.20)   74.2  (5.85)   70.5  (5.68)   76.5  (5.70)   73.6  (6.14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      10  34.5%      12  34.3%      15  51.7%      3  15.0%      40  35.4% 
Male      19  65.5%      23  65.7%      14  48.3%      17  85.0%      73  64.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      1   3.4%      0   0.0%      2   6.9%      0   0.0%      3   2.7% 
Not Hispanic or Latino      28  96.6%      35 100.0%      27  93.1%      20 100.0%      110  97.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   6.9%      4  11.4%      1   3.4%      0   0.0%      7   6.2% 
White      26  89.7%      31  88.6%      26  89.7%      19  95.0%      102  90.3% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   3.4%      0   0.0%      2   6.9%      1   5.0%      4   3.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions   [ Time Frame: 2 years ]

2.  Secondary:   Leukemia-free Survival (LFS)   [ Time Frame: 2 years ]

3.  Secondary:   Overall Survival   [ Time Frame: 2 years ]

4.  Secondary:   Pharmacokinetics Day 1 - Cmax (ng/mL)   [ Time Frame: 1 Day ]

5.  Secondary:   Pharmacokinetics Day 4 Cmax (ng/mL)   [ Time Frame: Day 4 ]

6.  Secondary:   All Cause Mortality   [ Time Frame: 30 and 60 days ]

7.  Secondary:   Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)   [ Time Frame: 1 Day ]

8.  Secondary:   Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)   [ Time Frame: 1 Day ]

9.  Secondary:   Pharmacokinetics Day 1 - CL (L/hr)   [ Time Frame: 1 Day ]

10.  Secondary:   Pharmacokinetics Day 1 - Vss (L)   [ Time Frame: 1 Day ]

11.  Secondary:   Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)   [ Time Frame: Day 4 ]

12.  Secondary:   Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)   [ Time Frame: Day 4 ]

13.  Secondary:   Pharmacokinetics Day 4 - CL (L/hr)   [ Time Frame: Day 4 ]

14.  Secondary:   Pharmacokinetics Day 4 - Vss (L)   [ Time Frame: Day 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the limited sample size in this study, further study is needed to confirm these results. No statistical testings were performed to compare any of the treatment groups. No p-values or odds ratios were reported.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linda Neuman, Vice President, Clinical Development
Organization: Sunesis Pharmaceuticals, Inc.
phone: (650) 266-3760
e-mail: lneuman@sunesis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00607997     History of Changes
Other Study ID Numbers: SPO-0014
Study First Received: January 23, 2008
Results First Received: March 27, 2017
Last Updated: May 25, 2017