AZD2171 in Treating Patients With Neurofibromatosis Type 1 and Plexiform Neurofibroma and/or Neurofibroma Near the Spine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00326872
First received: May 16, 2006
Last updated: April 24, 2014
Last verified: December 2013
Results First Received: July 10, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Neurofibromatosis Type 1
Plexiform Neurofibroma
Spinal Cord Neurofibroma
Intervention: Drug: cediranib maleate

  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
From 8/29/2006 until 7/31/2009, 26 patients were accrued.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 26 patients accrued were evaluable for the primary endpoint.

Reporting Groups
  Description
Treatment (Cediranib Maleate) Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Cediranib Maleate)  
STARTED     26  
COMPLETED     26  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Treatment (Cediranib Maleate) Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Cediranib Maleate)  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Median ( Full Range )
  34  
  ( 19 to 52 )  
Gender  
[units: participants]
 
Female     13  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures
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1.  Primary:   Proportion of Patients With Tumor Response (Complete Response [CR] or Partial Response [PR])   [ Time Frame: Baseline to end of treatment, maximum of 26 cycles (28 days/cycle). ]

2.  Secondary:   Survival Time as Measured Using Kaplan-Meier Method   [ Time Frame: From registration to death (due to any cause) max 51 months ]

3.  Secondary:   Time to Disease Progression as Measured Using Kaplan-Meier Method   [ Time Frame: From registration to documentation of disease progression up to 26 cycles (28 days/cycle). ]

4.  Secondary:   Duration of Response as Assessed Using the Method of Kaplan-Meier   [ Time Frame: From time of confirmed tumor objective response as CR or PR to the date of progression max 51 months ]

5.  Secondary:   Time to Treatment Failure as Assessed Using the Method of Kaplan-Meier   [ Time Frame: From the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal up to 51 months. ]

6.  Secondary:   Reduction in Self Reported Worst Pain Per Cycle.   [ Time Frame: At baseline, prior to each subsequent course (q 28+/- 3 days), and at end of treatment up to 51 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
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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: Dr. Dusica Babovic-Vuksanovic
Organization: Mayo Clinic
e-mail: dbabovic@mayo.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00326872     History of Changes
Obsolete Identifiers: NCT01646970, NCT01664390
Other Study ID Numbers: NCI-2009-00128, NCI-2009-00128, CDR0000475761, MC047F, 7133, N01CM62205
Study First Received: May 16, 2006
Results First Received: July 10, 2013
Last Updated: April 24, 2014
Health Authority: United States: Food and Drug Administration