Recruitment

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