Tipifarnib in Treating Older Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01361464
First received: May 24, 2011
Last updated: March 19, 2015
Last verified: February 2015
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Acute Megakaryoblastic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With Minimal Differentiation
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Adult Acute Myeloid Leukemia Without Maturation
Adult Acute Myelomonocytic Leukemia
Adult Erythroleukemia
Adult Pure Erythroid Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: Tipifarnib
Other: Laboratory Biomarker Analysis

  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. Further development of Tipifarnib in acute myeloid leukemia (AML) was terminated after the study failed to meet the primary endpoint.

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



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01361464     History of Changes
Obsolete Identifiers: NCT01364038
Other Study ID Numbers: NCI-2011-02589
NCI-2011-02589 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
16572
CDR0000699713
8977 ( Other Identifier: Moffitt Cancer Center )
8977 ( Other Identifier: CTEP )
P30CA076292 ( US NIH Grant/Contract Award Number )
N01CM00071 ( US NIH Grant/Contract Award Number )
U01CA070095 ( US NIH Grant/Contract Award Number )
N01CM00100 ( US NIH Grant/Contract Award Number )
Study First Received: May 24, 2011
Results First Received: November 15, 2013
Last Updated: March 19, 2015
Health Authority: United States: Food and Drug Administration