Status: Closed
Activation Date: 2010DEC09
Closing Date: 2012SEP24
Phase: II
Description: A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.
Eligibility: Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies. Must have formalin fixed paraffin embedded tissue available for translational studies. Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be > 1.0 cm). ECOG performance of 0, 1 or 2.Age > 18 years of age. Patients may have received prior adjuvant chemotherapy and/or concurrent chemoradiation as part of primary therapy, but must have received no therapy for recurrent/ progressive GBM
Objective: To determine the efficacy of PX-866 given orally daily in patients with glioblastoma at the time of first relapse or progression as assessed by objective response and early progression rates. To determine the safety and tolerability of PX-866 in patients with glioblastoma at first relapse/progression given in a daily oral schedule. To explore the relationship between objective response and molecular markers in archival tissue from glioblastoma patients treated with PX-866 orally daily.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to find out how effective the experimental drug PX-866 is in treating glioblastoma multiforme. In addition, this study will look at the side effects of PX-866. Treatment with PX-866 will be once daily by mouth for an 8-week cycle. Researchers will also look at cancer cell markers from the patient's archival tissue sample.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I204 | 34 | 21 | 28 | 33 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I204 | 34 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I204 | 34 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |