2020-05-27
2023-08-09
2024-02-05
52
NCT04386057
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
INTERVENTIONAL
LY3214996 +/- HCQ in Pancreatic Cancer
This study is evaluating the safety and efficacy of combining the study drug LY3214996 with hydroxychloroquine sulfate (HCQ) in patients with advanced pancreatic cancer.
* 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2020-05-10 | N/A | 2024-02-26 |
2020-05-10 | N/A | 2024-02-28 |
2020-05-13 | N/A | 2024-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Safety Lead-In Cohort 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 o | DRUG: Hydroxychloroquine Sulfate
DRUG: LY3214996
|
EXPERIMENTAL: LY3214996 and HCQ Combination 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 o | DRUG: Hydroxychloroquine Sulfate
DRUG: LY3214996
|
EXPERIMENTAL: LY3214996-Monotherapy 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 ou | DRUG: LY3214996
|
EXPERIMENTAL: Cross Over Arm 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 | DRUG: Hydroxychloroquine Sulfate
DRUG: LY3214996
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Disease control rate (DCR) | Anti-tumor activity will be measured via disease control rate (DCR), which will be defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) that persists for ≥ 4 months. | 28 Months |
Dose Limiting Toxicity-Lead In | Dose Limiting Toxicity-Lead In | 28 Days |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Objective response rate (ORR) | Objective response rate (ORR) | 28 Months |
Progression-free survival (PFS) | Progression-free survival (PFS) | time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation up to 28 Months |
Overall survival (OS) | Kaplan and Meier to assess Overall survival (OS) | 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 section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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