Gilead (GILD) Begins Phase 3 Trial Evaluating GS-1101 for Lymphocytic Leukemia
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Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the first patient has been dosed in a Phase 3 clinical trial evaluating the efficacy and safety of GS-1101 (formerly CAL-101). GS-1101 is an investigational, first-in-class specific inhibitor of the phosphoinositide-3 kinase (PI3K) delta isoform and is being evaluated in combination with rituximab in previously treated chronic lymphocytic leukemia (CLL) patients. The Phase 3 trial (Study 116) will enroll 160 patients at approximately 70 sites in the United States and Europe.
Study 116 is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of GS-1101 in combination with rituximab. The study will enroll 160 adult patients with previously treated recurrent CLL who have measureable lymphadenopathy, have experienced CLL disease progression less than 24 months following completion of prior therapy, and are currently not sufficiently fit to receive cytotoxic therapy because of comorbidities. Eligible patients will be randomized in a 1:1 ratio to receive eight infusions of rituximab over 24 weeks plus either GS-1101 (150 mg) or placebo taken orally twice daily on a continuous basis. The primary efficacy endpoint is progression-free survival (PFS).
Patients who are tolerating primary study therapy (GS-1101 or placebo) will be eligible to receive active GS-1101 therapy in a double-blind extension study (Study 117).
Study 116 is a randomized, double-blind, placebo-controlled, Phase 3 study evaluating the efficacy and safety of GS-1101 in combination with rituximab. The study will enroll 160 adult patients with previously treated recurrent CLL who have measureable lymphadenopathy, have experienced CLL disease progression less than 24 months following completion of prior therapy, and are currently not sufficiently fit to receive cytotoxic therapy because of comorbidities. Eligible patients will be randomized in a 1:1 ratio to receive eight infusions of rituximab over 24 weeks plus either GS-1101 (150 mg) or placebo taken orally twice daily on a continuous basis. The primary efficacy endpoint is progression-free survival (PFS).
Patients who are tolerating primary study therapy (GS-1101 or placebo) will be eligible to receive active GS-1101 therapy in a double-blind extension study (Study 117).
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