Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093470
First received: October 6, 2004
Last updated: October 13, 2015
Last verified: July 2015
Results First Received: October 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia in Remission
Interventions: Procedure: Clinical Observation
Drug: Tipifarnib

  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
This study was activated on August 18, 2004, suspended between August 8, 2007 and February 6, 2008 for toxicity and safety evaluation, and closed on December 7, 2009 with a total of 144 patients accrued.

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
Arm A (Tipifarnib)

Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tipifarnib: Given PO

Arm B (Clinical Observation)

Patients undergo observation only.

Clinical Observation: Undergo observation


Participant Flow:   Overall Study
    Arm A (Tipifarnib)     Arm B (Clinical Observation)  
STARTED     73     71  
Treated     72     71  
Patients With Toxicity Assessment     72     69  
COMPLETED     0 [1]   71 [2]
NOT COMPLETED     73     0  
Disease progression                 39                 0  
Adverse Event                 15                 0  
Death                 2                 0  
Withdrawal by Subject                 8                 0  
Alternative therapy                 2                 0  
Other complicating disease                 3                 0  
Physician Decision                 2                 0  
Never started treatment                 1                 0  
ANC < 1000 on day 1 of cycle 1                 1                 0  
[1] Treatment continued until disease progression or unacceptable toxicities.
[2] Patients underwent observation only.



  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.
All randomized patients

Reporting Groups
  Description
Arm A (Tipifarnib)

Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Tipifarnib: Given PO

Arm B (Clinical Observation)

Patients undergo observation only.

Clinical Observation: Undergo observation

Total Total of all reporting groups

Baseline Measures
    Arm A (Tipifarnib)     Arm B (Clinical Observation)     Total  
Number of Participants  
[units: participants]
  73     71     144  
Age  
[units: years]
Median (Full Range)
  70   (30 to 86)     69   (28 to 80)     69   (28 to 86)  
Gender  
[units: participants]
     
Female     37     34     71  
Male     36     37     73  



  Outcome Measures
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1.  Primary:   Disease-free Survival   [ Time Frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years. ]

2.  Secondary:   Overall Survival   [ Time Frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 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 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 more than 60 days but less than or equal to 180 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: Study statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-6012



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093470     History of Changes
Other Study ID Numbers: NCI-2009-00535
NCI-2009-00535 ( Other Identifier: CTRP (Clinical Trial Reporting Program) )
E2902 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA180820 ( US NIH Grant/Contract Award Number )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: October 6, 2004
Results First Received: October 13, 2015
Last Updated: October 13, 2015
Health Authority: United States: Food and Drug Administration