ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 39 for:    Von Hippel-Lindau Disease (VHL)

Phase II Study of Vandetanib in Individuals With Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00566995
Recruitment Status : Completed
First Posted : December 4, 2007
Results First Posted : March 11, 2015
Last Update Posted : April 7, 2015
Sponsor:
Information provided by (Responsible Party):
W. Marston Linehan, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Renal Cancer
Von Hippel Lindau
Intervention: Drug: ZACTIMA (Vandetanib) (ZD6474)

  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
Vandetanib in Participants With Kidney Cancer 300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days

Participant Flow:   Overall Study
    Vandetanib in Participants With Kidney Cancer
STARTED   37 
COMPLETED   29 
NOT COMPLETED   8 
Toxicity                3 
Physician Decision                1 
Withdrew consent                4 



  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
Vandetanib in Participants With Kidney Cancer 300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days

Baseline Measures
   Vandetanib in Participants With Kidney Cancer 
Overall Participants Analyzed 
[Units: Participants]
 37 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   36 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.65  (9.96) 
Gender 
[Units: Participants]
 
Female   21 
Male   16 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   2 
Not Hispanic or Latino   34 
Unknown or Not Reported   1 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   2 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   34 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   37 


  Outcome Measures

1.  Primary:   Overall Response Rate.   [ Time Frame: cycle 3, day 28 ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 72 months and 14 days ]


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. W. Marston Linehan
Organization: National Cancer Institute
phone: 301-496-6353
e-mail: linehanm@mail.nih.gov


Publications:

Responsible Party: W. Marston Linehan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00566995     History of Changes
Other Study ID Numbers: 080020
08-C-0020
First Submitted: December 1, 2007
First Posted: December 4, 2007
Results First Submitted: February 12, 2015
Results First Posted: March 11, 2015
Last Update Posted: April 7, 2015