Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
Study NCT ID:
NCT04386057
Status:
COMPLETED
Last Update Posted:
2025-02-12
First Post:
2020-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
LY3214996 +/- HCQ in Pancreatic Cancer
Sponsor:
Kimberly Perez, MD
Organization:
Study Overview
Official Title:
Phase II Trial of ERK Inhibition Alone and in Combination With Autophagy Inhibition in Patients With Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: