A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib. (NCT04534283) | Clinical Trial Compass
TerminatedPhase 2
A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.
Stopped: Lack of efficacy.
United States16 participantsStarted 2020-10-05
Plain-language summary
The purpose of CTO-IUSCC-0730 study is to assess the clinical efficacy of LY3214996 in combination with abemaciclib at the recommended phase 2 dose of LY3214996 200 mg orally daily and abemaciclib 150 mg orally twice daily. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if the study closes for any reason.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Amplification of RAF1 defined as \>6 copies of the respective gene.
✓. Gene fusion in which BRAF, RAF1, MEK1/2, or ERK1/2, is a fusion partner; in which the fusion is determined to be in-frame; and the kinase domain of BRAF, RAF1, MEK1/2, or ERK1/2 is retained.
✓. Point mutations, frameshift insertions/deletions, splice site mutations, or stop gain mutations that results in loss-of-function of NF1.
Exclusion criteria
✕. Have a serious concomitant systemic disorder (for example, active infection or a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting or diarrhea, or profound immune suppression) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
✕. Have or known activated/reactivated hepatitis A, B, or C (screening is not required).
✕. Uncontrolled human immunodeficiency virus (HIV) infection are considered ineligible. HIV- infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
✕. CD4 count ≥ 350 cells/mm3
What they're measuring
1
Overall Response Rate
Timeframe: from cycle 1 day 1 until safety follow up visit (up to 1 year)