This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Oral escalating dose
Intravenous repeating dose
Intravenous repeating dose
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Incidence of adverse events
Time frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Incidence of dose limiting toxicities (DLTs)
Time frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Nature of adverse events
Time frame: Up to 30 days after last dose of study treatment or initiation of new anti-cancer therapy, whichever comes first
Nature of dose limiting toxicities (DLTs)
Time frame: Up to 21 days from Last Patient In (LPI) in Stage 1 of study
Severity of adverse events
Time frame: Up to 30 days after last dose of study treatment
Total exposure
Time frame: Up to 32 months or early study discontinuation
Maximum plasma concentration
Time frame: Up to 32 months or early study discontinuation
Time to maximum observed plasma concentration
Time frame: Up to 32 months or early study discontinuation
Plasma half-life
Time frame: Up to 32 months or early study discontinuation
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intravenous repeating dose
Intravenous repeating dose
intravenous repeating dose
Madrid, Madrid, Spain