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A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer (VA)

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00748553
First received: September 4, 2008
Last updated: June 27, 2017
Last verified: June 2017
Results First Received: March 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Advanced or Metastatic Solid Tumors
Advanced or Metastatic Breast Cancer
Interventions: Drug: Azacitidine (Vidaza)
Drug: Nab-paclitaxel (Abraxane)

  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
Phase 1

Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle

Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle

Phase II Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2

Participant Flow:   Overall Study
    Phase 1   Phase II
STARTED   16   14 
COMPLETED   13   13 
NOT COMPLETED   3   1 
Adverse Event                0                1 
disease progression                2                0 
noncompliance                1                0 



  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.
In the Phase I cohort, two patients stopped during Cycle I due to disease progression, and one was removed in cycle 4 due to noncompliance. In the Phase II cohort, one patient opted out after 1 cycle because of toxicity.

Reporting Groups
  Description
Phase II Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2
Phase I

Azacitidine (Vidaza): 50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle

Nab-paclitaxel (Abraxane): 100mg/m2 weekly for 3 weeks of each 4-week cycle

Total Total of all reporting groups

Baseline Measures
   Phase II   Phase I   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   16   30 
Age 
[Units: Years]
Median (Full Range)
 65 
 (38 to 77) 
 62 
 (21 to 83) 
 63.5 
 (21 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14 100.0%      13  81.3%      27  90.0% 
Male      0   0.0%      3  18.8%      3  10.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  14.3%      5  31.3%      7  23.3% 
White      12  85.7%      10  62.5%      22  73.3% 
More than one race      0   0.0%      1   6.3%      1   3.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   14   16   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase I: Percentage of Participants Responding to Treatment   [ Time Frame: 6 months ]

2.  Primary:   Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria   [ Time Frame: 1.5 years ]

3.  Secondary:   Number of Participants With ER+ Status   [ Time Frame: 2 years ]

4.  Secondary:   Progression-free Survival   [ Time Frame: 2 years ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT 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/Title: Kimberlee Taylor
Organization: Huntsman Cancer Institute
phone: 8012135673
e-mail: Kimberlee.Taylor@hci.utah.edu



Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00748553     History of Changes
Other Study ID Numbers: HCI53993
Study First Received: September 4, 2008
Results First Received: March 14, 2017
Last Updated: June 27, 2017