Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Cediranib Maleate in Treating Patients With Recurrent or Metastatic Kidney Cancer That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00227760
First received: September 26, 2005
Last updated: January 29, 2016
Last verified: December 2013
Results First Received: January 29, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Interventions: Drug: Cediranib Maleate
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

  Participant Flow
  Hide Participant Flow

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
Treatment (Cediranib Maleate)

Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cediranib Maleate: Given PO

Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies


Participant Flow:   Overall Study
    Treatment (Cediranib Maleate)
STARTED   44 
COMPLETED   44 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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 cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cediranib Maleate: Given PO

Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies

Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies


Baseline Measures
   Treatment (Cediranib Maleate) 
Overall Participants Analyzed 
[Units: Participants]
 44 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   30 
>=65 years   14 
Age 
[Units: Years]
Median (Full Range)
 62 
 (44 to 83) 
Gender 
[Units: Participants]
 
Female   9 
Male   35 
Region of Enrollment 
[Units: Participants]
 
Canada   44 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Durable Stable Disease, Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: 4 weeks ]

2.  Primary:   Objective Response, Evaluated Using RECIST   [ Time Frame: 4 weeks ]

3.  Secondary:   Progression Free Survival   [ Time Frame: Time from start of treatment to progression, death or last contact, or last tumor assessment before the start of further antitumor therapy, assessed up to 6.5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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. Srikala Sridhar
Organization: Princess Margaret Cancer Centre - University Health Network
phone: 416-946-2249
e-mail: srikala.sridhar@uhn.ca



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00227760     History of Changes
Other Study ID Numbers: NCI-2013-01072
NCI-2013-01072 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000446080
PHL-039 ( Other Identifier: University Health Network Princess Margaret Cancer Center P2C )
7128 ( Other Identifier: CTEP )
N01CM62203 ( US NIH Grant/Contract Award Number )
Study First Received: September 26, 2005
Results First Received: January 29, 2016
Last Updated: January 29, 2016
Health Authority: United States: Food and Drug Administration