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 adults with recurrent or progressive grade II low-grade glioma, including glioblastoma and gliosarcoma. It is not an approved therapy for these tumors and was evaluated in a Phase 2 research setting in the United States.
Imatinib & Hydroxyurea combines imatinib mesylate, an inhibitor of ABL1, BCR, KIT and PDGFRB, with hydroxyurea. Imatinib blocks signaling through these targets, while hydroxyurea is an antineoplastic agent that interferes with DNA synthesis. The two agents were studied together as a small molecule combination in glioma.
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, and the combination with hydroxyurea was studied in a Phase 2 glioma trial. Hydroxyurea itself is a widely available generic chemotherapy agent.
Imatinib & Hydroxyurea is in Phase 2 development for glioma. The single registered study of this combination is a completed Phase 2 trial, and no active trials of the combination are currently listed. It is investigational and has not been established as an approved treatment for glioblastoma or low-grade glioma.
Imatinib & Hydroxyurea was studied in NCT00615927, a Phase 2 trial titled Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma. The trial enrolled 64 participants aged 18 years and older of all sexes, took place in the United States, used a controlled design, and is completed.