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LY3214996 +/- HCQ for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Brian Wolpin, MD, PHD
Research Sponsored by Kimberly Perez, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up overall survival (os) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive up to 34 months
Awards & highlights

Study Summary

This trial is testing a new drug, LY3214996, to see if it is safe and effective when combined with the existing drug HCQ for patients with advanced pancreatic cancer.

Who is the study for?
Adults with advanced pancreatic cancer who've had 1-2 prior treatments can join this trial. They need to be relatively healthy, able to take oral meds, and have a tumor that can be measured and biopsied. Women of childbearing age and men must use birth control. People with recent other treatments, brain metastases, certain heart issues or infections, pregnant women, those with specific genetic conditions or allergies related to the drugs cannot participate.Check my eligibility
What is being tested?
The study is testing if LY3214996 combined with hydroxychloroquine sulfate (HCQ) is safe and works against advanced pancreatic cancer. Participants will receive both medications orally to see how well they work together in treating their cancer.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with anti-cancer agents such as nausea, fatigue, liver function changes, risk of infection due to bone marrow suppression; specific risks from these drugs are not listed but could align with known effects of similar therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is a type of pancreatic cancer confirmed by lab tests.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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I have at least one tumor that can be measured.
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I have had 1 or 2 treatments for metastatic pancreatic cancer.
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I can swallow and keep down pills.
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I am willing and able to have a biopsy of my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~overall survival (os) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive up to 34 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and overall survival (os) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive up to 34 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease control rate (DCR)
Dose Limiting Toxicity-Lead In
Secondary outcome measures
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Safety Lead-In CohortExperimental Treatment2 Interventions
The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Test the safety of study drugs in combination and define dose levels. LY3214996 HCQ
Group II: LY3214996-MonotherapyExperimental Treatment1 Intervention
The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days.Treatment will be administered on an outpatient basis. -LY3214996
Group III: LY3214996 and HCQ CombinationExperimental Treatment2 Interventions
The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. A treatment cycle will be defined as 28 consecutive days. Treatment will be administered on an outpatient basis. Combined dosage per determined Lead-In Cohort LY3214996 HCQ
Group IV: Cross Over ArmExperimental Treatment2 Interventions
Participants who are enrolled to Arm 2 who experience radiologic disease progression on monotherapy will have the option to cross-over to receive treatment with the combination. Crossover will occur at the treating investigator's discretion following consultation and approval from the overall principal investigator. Combined dosage per determined Lead-In Cohort LY3214996 HCQ
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3214996
2019
Completed Phase 2
~270
Hydroxychloroquine Sulfate
2015
Completed Phase 4
~1080

Find a Location

Who is running the clinical trial?

Kimberly Perez, MDLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,613 Previous Clinical Trials
3,200,877 Total Patients Enrolled
Kimberly PerezLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

LY3214996 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04386057 — Phase 2
Pancreatic Cancer Research Study Groups: Cross Over Arm, Safety Lead-In Cohort, LY3214996-Monotherapy, LY3214996 and HCQ Combination
Pancreatic Cancer Clinical Trial 2023: LY3214996 Highlights & Side Effects. Trial Name: NCT04386057 — Phase 2
LY3214996 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04386057 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any past investigations involving LY3214996?

"LY3214996 was first researched at University of Nebraska Medical Center in 2007, and since then 135 trials have been completed. Currently, 64 medical experiments are ongoing with the majority hosted out of Chapel Hill, North carolina."

Answered by AI

Are there any remaining opportunities to join this clinical trial?

"Affirmative. The information made available on clinicaltrials.gov reveals that this medical trial, which was initially advertised around May 27th 2020, is actively looking for participants. Approximately 52 individuals must be recruited from 3 separate healthcare facilities."

Answered by AI

What is the current sample size for this research investigation?

"Affirmative, the information on clinicaltrials.gov affirms that this research is actively recruiting individuals. The trial was first made available to potential participants on May 27th 2020 and has since been modified as recently as April 6th 2022. There are 52 openings distributed among 3 different medical sites."

Answered by AI

In what cases is LY3214996 typically prescribed?

"LY3214996 is traditionally prescribed to cure malaria, but can also effectively manage q fever, rheumatoid arthritis and sjögren's syndrome."

Answered by AI

Has the FDA granted licensing to LY3214996?

"We assessed LY3214996's safety rating at 2 as this Phase 2 trial has collected evidence that it is secure but not yet proven to be effective."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
LY3214996 +/- HCQ in Pancreatic Cancer
Kimberly Perez, MD 2020. "LY3214996 +/- HCQ in Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04386057.
~11 spots leftby Apr 2025
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