A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.
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|ClinicalTrials.gov Identifier: NCT04534283|
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : November 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer Cancer Metastatic BRAF V600E MEK1 Gene Mutation MEK2 Gene Mutation ERK Mutation RAF1 Gene Mutation||Drug: Abemaciclib Drug: LY3214996||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib for Patients Whose Tumors Harbor Pathogenic Alterations in BRAF, RAF1, MEK1/2, ERK1/2, and NF1.|
|Actual Study Start Date :||September 28, 2020|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: Abemaciclib + LY3214996
Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
Other Name: LY2835219
Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
- Overall response rate [ Time Frame: from cycle 1 day 1 until safety follow up visit (up to 1 year) ]the number of patients who achieve a best overall response of complete response (CR) or partial response (PR) divided by the total number of patients treated (safety population)
- Incidence of Adverse Events [ Time Frame: baseline until safety follow up visit (up to 1 year) ]CTCAE Version 5.0 will be used to summarize adverse events in the assessment of safety for incorporating LY3214996 in combination with abemaciclib. Summaries of treatment related adverse events in the population will be tabulated. All adverse events (AEs) will be presented in incidence tables coded by CTC term.
- Duration of Overall Response Rate [ Time Frame: up to 1 year ]measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
- Duration of Progression free survival [ Time Frame: up to 1 year ]the time from the date of start of treatment to the first date of the observed clinical or radiologically documented PD or death due to any cause, whichever occurs first. For patients who are not known to have died or progressed as of the data-inclusion cut-off date, PFS time will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534283
|Contact: Anne Younger, RNfirstname.lastname@example.org|
|United States, Indiana|
|Indiana University Hospital / IU Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Anne Younger, RN 317-274-0951 email@example.com|
|Sub-Investigator: Milan Radovich, PhD|
|Sub-Investigator: Bryan Schneider, MD|
|Sub-Investigator: Kathy Miller, MD|
|Sub-Investigator: Paul Helft, MD|
|Principal Investigator:||Anita Turk, MD||Indiana University|