Return to Clinical Trials Search Results

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5829 as a Monotherapy in Subjects with Advanced Solid Tumors and Lymphomas and in combination with Exemestane or Fulvestrant in Subjects with Estrogen Receptor Positive Breast Cancer

Charactierize the safety and tolerability of GS-5829 as a monotherapy in subjects with advanced solid tumors and lymphomas Determine the maximum tolerated dose (MTD) or recommended dose for phase 2 (RDP2) of GS-5829 as a monotherapy in subjects with advanced solid tumors and lymphomas characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Determine the MTD or RDP2 of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Secondary Obj: Evaluate the pharmacokinetics (PK) of GS-5829 alone in subjects with advanced solid tumors and lymphomas and in combination with exemestance or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Exploratory Obj: Evaluate exploratory pharmacodynamic (PD) , predictive, and prognostic biomarkers associated with disease prognosis and/or benefit from GS-5829 Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with advanced stage solid tumors as measured by overall response rate (ORR) Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with relapsed or refractory aggressive lymphomas (diffuse large B cell lymphoma (DLBCL), or peripheral T cell lymphoma (PTCL) as measured by ORR Evaluate the preliminary efficacy of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen recptor positive breast cancer as measured by ORR Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with advanced stage solid tumors as measured by progression-freee survival (PFS) Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with relapsed or refractory lymphomas (DLBC or PTCL) as measured by PFS Evaluate the preliminary efficacy of GS-5829 in combination with exemestane or fulvestrant in subjecs with advanced estrogen receptor positive breast cancer as measured by PFS.

Charactierize the safety and tolerability of GS-5829 as a monotherapy in subjects with advanced solid tumors and lymphomas Determine the maximum tolerated dose (MTD) or recommended dose for phase 2 (RDP2) of GS-5829 as a monotherapy in subjects with advanced solid tumors and lymphomas characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Determine the MTD or RDP2 of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Secondary Obj: Evaluate the pharmacokinetics (PK) of GS-5829 alone in subjects with advanced solid tumors and lymphomas and in combination with exemestance or fulvestrant in subjects with advanced estrogen receptor positive breast cancer Exploratory Obj: Evaluate exploratory pharmacodynamic (PD) , predictive, and prognostic biomarkers associated with disease prognosis and/or benefit from GS-5829 Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with advanced stage solid tumors as measured by overall response rate (ORR) Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with relapsed or refractory aggressive lymphomas (diffuse large B cell lymphoma (DLBCL), or peripheral T cell lymphoma (PTCL) as measured by ORR Evaluate the preliminary efficacy of GS-5829 in combination with exemestane or fulvestrant in subjects with advanced estrogen recptor positive breast cancer as measured by ORR Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with advanced stage solid tumors as measured by progression-freee survival (PFS) Evaluate the preliminary efficacy of GS-5829 as a monotherapy in subjects with relapsed or refractory lymphomas (DLBC or PTCL) as measured by PFS Evaluate the preliminary efficacy of GS-5829 in combination with exemestane or fulvestrant in subjecs with advanced estrogen receptor positive breast cancer as measured by PFS.