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A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma (PD0332991)

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01227434
First received: October 15, 2010
Last updated: June 15, 2015
Last verified: June 2015
Results First Received: May 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glioblastoma
Gliosarcoma
Anaplastic Astrocytoma
Interventions: Drug: PD 0332991 (pre-surgery)
Drug: PD 0332991
Procedure: Resection as clinical care

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 23 participants consented, 1 was found ineligible prior to randomization

Reporting Groups
  Description
Surgical Group PD 0332991 125 mg daily for 7 days prior to an indicated, surgical resection for progression, and resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
Non-surgical Group Patients not in need of surgery treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.

Participant Flow:   Overall Study
    Surgical Group     Non-surgical Group  
STARTED     6     16  
COMPLETED     6     16  
NOT COMPLETED     0     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
Surgical Group PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
Non-surgical Group Patients not in need of surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
Total Total of all reporting groups

Baseline Measures
    Surgical Group     Non-surgical Group     Total  
Number of Participants  
[units: participants]
  6     16     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     14     19  
>=65 years     1     2     3  
Gender  
[units: participants]
     
Female     3     7     10  
Male     3     9     12  
Region of Enrollment  
[units: participants]
     
United States     6     16     22  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: up to 142 weeks ]

2.  Secondary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 1-2 years ]


  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 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: Michael Prados, MD
Organization: University of California San Francisco
phone: 4154767217
e-mail: pradosm@neurosurg.ucsf.edu



Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01227434     History of Changes
Other Study ID Numbers: 10105
Study First Received: October 15, 2010
Results First Received: May 18, 2015
Last Updated: June 15, 2015
Health Authority: United States: Food and Drug Administration