Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 ...
Imatinib & Hydroxyurea is an investigational combination of two small molecule drugs studied in neuro-oncology. It pairs imatinib, a targeted kinase inhibitor, with hydroxyurea, and was evaluated in a Phase 2 trial for patients with recurrent or progressive grade II low-grade glioma. The combination is not an approved therapy and remains in clinical development.
Imatinib & Hydroxyurea was studied for recurrent or progressive grade II low-grade glioma, a brain tumor setting that includes glioblastoma and gliosarcoma. The Phase 2 trial enrolled 64 patients aged 18 years and older in the United States. It is an investigational combination and is not an approved treatment for glioblastoma.
Imatinib, the targeted component of this combination, inhibits ABL1, BCR, KIT, and PDGFRB. Hydroxyurea is a small molecule that acts through a different mechanism. Together the two agents were tested as a kinase-directed strategy in glioma, and the trial used biomarker selection to identify appropriate patients.
Novartis AG, which trades under the ticker NVS, is the developer associated with the imatinib component of this combination. Imatinib mesylate is a Novartis small molecule kinase inhibitor, and the Phase 2 study combined it with hydroxyurea in patients with recurrent or progressive low-grade glioma.
Imatinib & Hydroxyurea is in Phase 2 development. The single registered trial, NCT00615927, has completed, and no trials are currently active. The study was controlled but not randomized and not double blinded, and it enrolled 64 patients with recurrent or progressive grade II low-grade glioma.
Imatinib & Hydroxyurea has been evaluated in one clinical trial, NCT00615927, titled Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma. The completed Phase 2 study enrolled 64 participants aged 18 years and older across sites in the United States and included biomarker-selected patients.