LY3214996 +/- HCQ in Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Cancer
- Pancreatic Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 procedure...
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.
Tracking Information
- NCT #
- NCT04386057
- Collaborators
- Eli Lilly and Company
- Investigators
- Principal Investigator: Brian Wolpin, MD, PHD Dana-Farber Cancer Institute