An Open-Label, Phase 2 Trial of Orally Administered PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma (GBM)
ARM A:
- Each treatment cycle lasts four weeks (28 days). There are no breaks from taking
PF-00299804 between treatment cycles. Participants will take PF-00299804 once a day for
a total of 7 to 9 days before surgery. They will then stop taking PF-00299804 until
they have recovered from surgery.
- Once they have recovered from surgery, they will continue to take PF-00299804 once a
day until their disease worsens, they experience side effects or they decide to stop
study treatment.
- The following tests and procedures will be performed at the time intervals specified:
Research blood tests (Day 1 of study drug administration, day of surgery, day 1 of all
cycles after surgery, day 14 of the first cycle after surgery); tissue samples (day of
surgery); physical and neuro exams (day 1 of all cycles after surgery); skin exam (day
1 of all cycles after surgery and day 14 of the first cycle after surgery).
- An assessment of the tumor by CT or MRI scan will be made within 24 hours after
surgery. Another assessment by CT or MRI scan will be made at the end of cycle 2 and
then at the end of every even numbered cycle thereafter.
ARM B & C:
- Each treatment cycle lasts four weeks (28 days). There are no breaks from taking
PF-00299804 between treatment cycles. Participants will take PF-00299804 orally once a
day until their disease worsens, they experience any side effect, or if they decide to
stop study treatment.
- Participants will come into the clinic on Day 1 and Day 14 of Cycle 1, and then on Day
1 of all subsequent cycles for some of the following tests and procedures: research
blood tests, physical and neuro exams, skin exam, urine test and Patient Reported
Outcomes questionnaire.
- An assessment of the participants tumor by CT scan or MRI scans will be done at the end
of Cycle 2, 4 and then every other cycle thereafter.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival
Assess progression-free survival at six months in patients with recurrent GBM and EGFR amplification in archival tumor material who are treated with continuous daily dosing of PF-00299804 (Arm B)
2 years
No
Tracy T. Batchelor, MD
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
09-468
NCT01112527
April 2010
October 2012
Name | Location |
---|---|
Henry Ford Hospital | Detroit, Michigan 48202 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |