Zarnestra in Newly Diagnosed Acute Myelogenous Leukemia (AML)With 2 Gene Expression Signature Ratio

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01361464
First received: May 24, 2011
Last updated: April 4, 2014
Last verified: April 2014
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Myelogenous Leukemia
Intervention: Drug: R115777

  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
The Southeast Phase II Consortium (SEP2C) enrolled participants at 3 cancer centers in the United States. The study opened to accrual on 5/24/2011 and closed to accrual 07/25/2012 when the pharmaceutical company decided to terminate further development of Tipifarnib in acute myeloid leukemia (AML).

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
R115777 Therapy Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.

Participant Flow:   Overall Study
    R115777 Therapy  
STARTED     21  
COMPLETED     18  
NOT COMPLETED     3  
Death                 1  
Withdrawal by Subject                 2  



  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
R115777 Therapy Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.

Baseline Measures
    R115777 Therapy  
Number of Participants  
[units: participants]
  21  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     21  
Age  
[units: years]
Median ( Full Range )
  75  
  ( 66 to 84 )  
Gender  
[units: participants]
 
Female     10  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     21  



  Outcome Measures
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1.  Primary:   Complete Remission (CR) Rate   [ Time Frame: From first treatment through follow up period, an expected average of 12 months ]

2.  Secondary:   Median Overall Survival (OS)   [ Time Frame: From first treatment through follow up period, an expected average of 12 months ]

3.  Secondary:   Median 1-Year Survival Rate   [ Time Frame: 1 year ]

4.  Secondary:   Number of Participants With Relapse Free Survival   [ Time Frame: 7 months ]


  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 trial not meeting primary endpoint of at least 3 CR/CRi after 2 cycles, accrual was suspended. 1 year survival was not calculated, not relevant in the setting of a median survival of 6.6 months and with study not meeting its primary endpoint.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeffrey Lancet, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-6841
e-mail: jeffrey.lancet@moffitt.org


No publications provided


Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01361464     History of Changes
Other Study ID Numbers: NCI # 8977, MCC-16572
Study First Received: May 24, 2011
Results First Received: November 15, 2013
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board