Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Imatinib Mesylate & Hydroxyurea
Imatinib & Hydroxyurea · 1 trial · 2 indications
Percentage of participants surviving twelve months from the start of cycle 1 without progression of disease. PFS was defined as the time from the cycle 1 start date to the date of the first documented progression according to modified Macdonald criteria, or to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Astrocytoma | EXPERIMENTAL | Grade II Astrocytoma |
| Oligodendroglioma | EXPERIMENTAL | Grade II Oligodendroglioma or oligoastrocytomas |
| Name | Type | Description |
|---|---|---|
| Imatinib Mesylate & Hydroxyurea | DRUG | Imatinib administered orally on daily. Imatinib is local irritant \& must be taken in sitting position; mini of 2hrs should be allowed between last drug intake \& going to bed. Imatinib doses 400mg/600mg administered once daily, whereas daily doses of 800mg/\> administered as equally divided dose taken twice day. Dose for imatinib: Pts not receiving p450-inducing antiepileptic drugs: 400 mg/day. Pts receiving p450-inducing antiepileptic drugs: 500 mg twice day. It is recommended that pts take their prescribed imatinib mesylate at same time that they take their prescribed hydroxyurea, however, 30-60min interval between agents is acceptable if required for practical/other compliance issues. Hydroxyurea administered orally twice day. Dosing will begin on day 1 of cycle 1 \& continue daily. Drug is approximately 80 percent bioavailable. Dose will be 500mg twice day for all pts. |
Inclusion Criteria: * Patients with grade II LGG that is recurrent/progressive following prior surgical resection while on non-decreasing dose of corticosteroids * \> 25percent enlargement of bidimensional measure/new lesions on sequential imaging new \&/or worsening neurologic deficits * Patients ...