Trametinib + Hydroxychloroquine for Pancreatic Cancer
(THREAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial studies the sides effects and best dose of hydroxychloroquine when given together with trametinib in treating patients with pancreatic cancer that has spread to nearby tissue, lymph nodes or other places in the body and cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib together with hydroxychloroquine may work better in treating patients with pancreatic cancer.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot have received certain cancer treatments or investigational therapies within 2 weeks before starting the study treatment.
What safety data exists for Hydroxychloroquine and Trametinib in humans?
How is the drug combination of Trametinib and Hydroxychloroquine unique for treating pancreatic cancer?
The combination of Trametinib and Hydroxychloroquine is unique because it targets pancreatic cancer in a novel way by combining a MEK inhibitor (Trametinib) with an autophagy inhibitor (Hydroxychloroquine), and it is being explored as a third-line treatment option when standard treatments are not available.678910
What data supports the effectiveness of the drug combination of Trametinib and Hydroxychloroquine for pancreatic cancer?
Preclinical studies have shown promising results for the combination of Trametinib and Hydroxychloroquine in treating pancreatic cancer, although these regimens have not been extensively tested in patients. Additionally, Hydroxychloroquine combined with gemcitabine has been effective in increasing surgery rates and showing positive biomarker responses in pancreatic cancer patients.67101112
Who Is on the Research Team?
Conan G. Kinsey
Principal Investigator
Huntsman Cancer Institute/ University of Utah
Are You a Good Fit for This Trial?
This trial is for adults with advanced pancreatic cancer that has spread and isn't eligible for surgery. Participants must have tried two standard treatments or refused them, have measurable disease, be able to provide a biopsy, and have functioning major organs. They should not be pregnant, agree to use effective contraception, and not have certain health conditions like active bleeding or recent major surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive trametinib and hydroxychloroquine orally on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the assessment of adverse events.
Long-term follow-up
Participants are assessed for response rate to the treatment over an extended period.
What Are the Treatments Tested in This Trial?
Interventions
- Hydroxychloroquine
- Trametinib
Hydroxychloroquine is already approved in United States, European Union for the following indications:
- Malaria
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Malaria
- Rheumatoid Arthritis
- Systemic Lupus Erythematosus
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
Novartis Pharmaceuticals
Industry Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD