NCT04386057

LY3214996 +/- HCQ in Pancreatic Cancer

Phase II Trial of ERK Inhibition Alone and in Combination With Autophagy Inhibition in Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Kimberly Perez, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Advanced Cancer

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine Sulfate	HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle
DRUG	LY3214996	LY3214996-daily oral dosage per protocol per 28 day cycle

Timeline

• Start date: 2020-05-27
• Primary completion: 2023-08-09
• Completion: 2024-02-05
• First posted: 2020-05-13
• Last updated: 2025-02-12
• Results posted: 2024-11-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study