Spectrum Pharma (SPPI) Initiates Lucanthone Phase 2 in GBM
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Spectrum Pharmaceuticals (Nasdaq: SPPI), announced the initiation of an international, randomized, placebo-controlled Phase 2 study evaluating lucanthone in primary therapy for Glioblastoma Multiforme (GBM). An orally administered small molecule, lucanthone inhibits topoisomerase II and AP endonuclease and has been shown to sensitize tumor cells to radiation and chemotherapy by inhibiting DNA repair.
The international, multicenter, randomized, double-blind, placebo-controlled, Phase 2 study is designed to evaluate the safety and efficacy of lucanthone administered in combination with temozolomide (TMZ) and radiation treatment, the current standard of care in primary therapy for GBM. The study is expected to enroll approximately 140 patients, who will be randomized in a 1:1 fashion to one of two groups: 6-week treatment of 1) focal radiation + TMZ + lucanthone (active arm) or 2) focal radiation +TMZ + placebo (control arm). This concomitant treatment phase will be followed by a maintenance phase of lucanthone (active arm) or placebo (control arm) administered with TMZ on days 1-5 of a 28-day cycle for 6 cycles. The Phase 2 study primary endpoint is progression free survival (PFS) at 9 months, and secondary endpoints include PFS at 1 year and overall survival (OS) at 1 year. The trial is being conducted at multiple sites in the U.S., as well as in India through Spectrum’s subsidiary, OncoRx.
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The international, multicenter, randomized, double-blind, placebo-controlled, Phase 2 study is designed to evaluate the safety and efficacy of lucanthone administered in combination with temozolomide (TMZ) and radiation treatment, the current standard of care in primary therapy for GBM. The study is expected to enroll approximately 140 patients, who will be randomized in a 1:1 fashion to one of two groups: 6-week treatment of 1) focal radiation + TMZ + lucanthone (active arm) or 2) focal radiation +TMZ + placebo (control arm). This concomitant treatment phase will be followed by a maintenance phase of lucanthone (active arm) or placebo (control arm) administered with TMZ on days 1-5 of a 28-day cycle for 6 cycles. The Phase 2 study primary endpoint is progression free survival (PFS) at 9 months, and secondary endpoints include PFS at 1 year and overall survival (OS) at 1 year. The trial is being conducted at multiple sites in the U.S., as well as in India through Spectrum’s subsidiary, OncoRx.
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