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Cediranib Maleate With or Without Gefitinib in Treating Patients With Recurrent or Progressive Glioblastoma

This study has been terminated.
(closed to recruitment early due to AstraZeneca not developing cediranib further)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01310855
First received: March 5, 2011
Last updated: May 2, 2017
Last verified: May 2017
Results First Received: December 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Glioblastoma
Interventions: Drug: cediranib maleate
Drug: gefitinib
Drug: Placebo

  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
Trial closed prematurely because cediranib manufacture was discontinued by AZ. Only 38 patients were recruited

Reporting Groups
  Description
Cediranib & Gefitinib

Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.

cediranib maleate

gefitinib

Cediranbib & Placebo

Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.

cediranib maleate

Placebo


Participant Flow:   Overall Study
    Cediranib & Gefitinib   Cediranbib & Placebo
STARTED [1]   19   19 
COMPLETED   19   19 
NOT COMPLETED   0   0 
[1] 112 patients were to be recruited but 38 recruited due to the early discontinuation of cediranib



  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
Cediranib & Gefitinib

Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.

cediranib maleate

gefitinib

Cediranbib & Placebo

Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.

cediranib maleate

Placebo

Total Total of all reporting groups

Baseline Measures
   Cediranib & Gefitinib   Cediranbib & Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   38 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15  78.9%      15  78.9%      30  78.9% 
>=65 years      4  21.1%      4  21.1%      8  21.1% 
Age 
[Units: Years]
Mean (Full Range)
 54.4 
 (30 to 71) 
 56.9 
 (40 to 69) 
 55.7 
 (30 to 71) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  68.4%      14  73.7%      27  71.1% 
Male      6  31.6%      5  26.3%      11  28.9% 
Region of Enrollment 
[Units: Participants]
     
United Kingdom   19   19   38 


  Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: from the date of randomisation to the date of first progression or death due to any cause, until 6 months from the date the last patient finished trial treatment (the day after the date that the last trial drug was taken) ]

2.  Secondary:   Overall Survival   [ Time Frame: from date of randomization to date of Death due to any cause. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Radiographic Response Rate   [ Time Frame: from baseline scan to six week and 12 week scans ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Progression-free Survival Rate at 6 Months   [ Time Frame: from the date of randomisation to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Steroid Use   [ Time Frame: from randomization to first increase in dexamethasone dose ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Time to Deterioration of Neurological Status   [ Time Frame: from date of randomization to the date of first neurological status worsening in comparison to baseline (first of 2 confirmatory reports at 2 consecutive visits, 6 weeks apart) as assessed by the clinician, or until date of death, whichever is first. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Safety and Tolerability   [ Time Frame: from date of randomisation to death ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Mark Phillips
Organization: UCL and CTC Cancer Trials Centre
phone: 0207 679 9139
e-mail: ctc.doric@ucl.ac.uk


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01310855     History of Changes
Other Study ID Numbers: CDR0000696313
UCL-10/0035
ZENECA-ISSRECE00002
EUDRACT-2010-021531-13
CRUKE/10/044
Study First Received: March 5, 2011
Results First Received: December 2, 2016
Last Updated: May 2, 2017