Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT04386057
Brief Summary:
This study is evaluating the safety and efficacy of combining the study drug LY3214996 with hydroxychloroquine sulfate (HCQ) in patients with advanced pancreatic cancer.
Detailed Description:
* This is an open label, randomized, two arm, phase II with safety lead- in study exploring the anti-tumor activity of the extracellular signal-regulated kinase (ERK) inhibitor LY3214996 with and without hydroxychloroquine (HCQ) in patients with advanced pancreatic cancer.
* The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* The safety lead-in will test the safety of a combination of investigational drugs and also try to define appropriate dosage. The names of the study drugs involved in this study are:
* LY3214996
* Hydroxychloroquine Sulfate (HCQ)
* Following completion of a brief combination treatment safety lead-in cohort, participants will be randomized 1:1 for enrollment to one of two treatment arms:
* Arm 1: receiving combination treatment with LY3214996 and HCQ
* Arm 2: receiving monotherapy treatment with LY3214996
It is expected that about 52 people will take part in this research study
The U.S. Food and Drug Administration (FDA) has not approved LY3214996 as a treatment for any disease.
The U.S. Food and Drug Administration (FDA) has not approved HCQ for your specific disease but it has been approved for other uses.
Study:
NCT04386057
Study Brief:
Protocol Section:
NCT04386057