PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT01112527|
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma GBM Glioblastoma Multiforme||Drug: PF-00299804||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase 2 Trial of Orally Administered PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma (GBM)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Arm A
Patients with Glioblastoma that has returned or grown after chemotherapy or radiation treatment and who will be having a standard operation to remove the tumor.
Taken orally once a day
Experimental: Arm B
Participants with glioblastoma at first recurrence who are not surgical candidates and who have not had prior anti-VEGF therapy.
Taken orally once a day
Experimental: Arm C
Participants with glioblastoma who are not surgical candidates and who are at first recurrence from a therapeutic regimen containing bevacizumab.
Taken orally once a day
- Progression-Free Survival [ Time Frame: 2 years ]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)
- Ability of PF-00299804 to cross the blood-brain barrier [ Time Frame: 2 years ]Assess the ability of PF-00299804 to cross the blood-brain barrier in GBM patients who are candidates for surgical re-section in Arm A.
- Safety and tolerability [ Time Frame: 2 years ]Evaluate the safety and tolerability of orally administered PF-00299804 on a continuous dosing schedule in patients with recurrent GBM.
- Anti-tumor response [ Time Frame: 2 years ]Assess anti-tumor response in patients in Arm B
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112527
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Tracy T. Batchelor, MD||Massachusetts General Hospital|