GNS561 and Trametinib Trial for Liver Cancer
Phase 1/2
74
about 3.2 years
18+
10 sites in CA, FL, IL +5
What this study is about
Researchers are testing a treatment (GNS561 + trametinib) in people with advanced liver cancer that has not responded to standard treatments. The trial will last about 1 year, and it's designed to see if this combination of drugs is safe and effective.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take GNS561 + Trametinib
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Assignment is predetermined by the study protocol.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
trametinib
oral (Oral Tablet)
Primary: Incidence of dose limiting toxicity (DLT) of GNS561 with trametinib (Phase 1b), Objective response rate (ORR) of the combination of GNS561 with trametinib (Phase 2a)
Secondary: Disease Control Rate (DCR), Duration of response (DoR), Incidence and severity of treatment emergent adverse event (TEAEs), incidence of serious adverse events (SAEs), incidence of TRAEs, incidence of adverse events of special interest (AESIs), rate of treatment discontinuation or interruption for TRAEs, Overall Survival (OS) time, Progression-free survival (PFS), Time To Progression (TTP), Time To Response (TTR)