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Autophagy Inhibitor
Trametinib + Hydroxychloroquine for Pancreatic Cancer (THREAD Trial)
Phase 1
Recruiting
Led By Conan Kinsey, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Subject with histologically confirmed metastatic or locally advanced, unresectable pancreatic carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
THREAD Trial Summary
This trial is testing hydroxychloroquine given with trametinib to see if it is effective and has manageable side effects for pancreatic cancer patients.
Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing the combination of Trametinib and Hydroxychloroquine in patients with pancreatic cancer. Trametinib blocks enzymes needed for cell growth while Hydroxychloroquine may prevent tumor cells from growing or spreading. The goal is to find the best dose of Hydroxychloroquine that can be given safely with Trametinib.See study design
What are the potential side effects?
Potential side effects include issues related to liver function (like elevated enzyme levels), blood disorders (such as low neutrophil count), eye problems (including retinal vein occlusion), gastrointestinal disturbances, increased risk of infections due to immune system suppression, fatigue, skin reactions, and possible allergic responses.
THREAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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My pancreatic cancer cannot be removed by surgery and has spread.
Select...
My liver enzymes are within the required range.
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My cancer can be measured on a CT scan according to specific criteria.
Select...
My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.
THREAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of dose-limiting toxicities during the DLT assessment window.
Secondary outcome measures
Incidence of adverse events (AEs) for the duration of study treatment
Response Rate
Side effects data
From 2016 Phase 3 trial • 217 Patients • NCT0205725013%
Upper respiratory tract infection
6%
Neutropenia
6%
Sinusitis
5%
Alanine aminotransferase increased
5%
Urinary tract infection
4%
Injection site erythema
4%
Accidental overdose
4%
Bronchitis
3%
Injection site pruritus
2%
Thrombocytopenia
2%
Nasopharyngitis
2%
Contusion
1%
Arthralgia
1%
Anaemia
1%
Lumbar spinal stenosis
1%
Leukopenia
1%
Coronary artery occlusion
1%
Wolff-Parkinson-White syndrome
1%
Transient ischaemic attack
1%
Vertebrobasilar insufficiency
1%
Chronic obstructive pulmonary disease
1%
Small intestinal obstruction
1%
Nephrolithiasis
1%
Cataract
1%
Thrombophlebitis superficial
1%
Vomiting
1%
Endometrial hyperplasia
1%
Traumatic arthritis
1%
Hypertension
1%
Pneumonia
1%
Pancreatic carcinoma metastatic
1%
Osteoarthritis
1%
Rheumatoid lung
1%
Pharyngitis
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarilumab 150 mg by PFS (Extension Phase)
Sarilumab 150 mg by AID (AID Assessment Phase)
Sarilumab 150 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by PFS (AID Assessment Phase)
Sarilumab 200 mg by AID (AID Assessment Phase)
THREAD Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib, hydroxychloroquine)Experimental Treatment2 Interventions
Patients receive trametinib PO QD on days 1-28 and hydroxychloroquine PO QD or BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550
Hydroxychloroquine
2017
Completed Phase 4
~5360
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsIndustry Sponsor
2,858 Previous Clinical Trials
4,197,804 Total Patients Enrolled
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,650 Total Patients Enrolled
Conan Kinsey, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and perform daily activities.You have enough infection-fighting white blood cells in your body.I have recovered from previous treatment side effects, or they are minor and stable.I have not had radiotherapy in the last 2 weeks, except for treating bone metastasis.I had major surgery less than 3 weeks ago or am still dealing with its side effects.I am using or willing to use effective birth control during and for 4 months after the study.I have had a major bleeding event in the past.My pancreatic cancer cannot be removed by surgery and has spread.I am willing to have my health monitored during and after the study, unless my condition worsens.I have more than one type of cancer, but only my pancreatic cancer needs treatment.My doctor says I can't have blood clot prevention treatment.Your hemoglobin level is at least 9 grams per deciliter.Your bilirubin level is not higher than 1.5 times the normal range.Women who could become pregnant must have a negative pregnancy test before joining the study.Criterion: You have uncontrolled, significant health issues, such as heart problems, G6PD deficiency, seizures, or certain infections. You also cannot participate if you are pregnant, have certain infections, or have conditions that may affect your ability to understand and follow the study requirements.My liver enzymes are within the required range.I haven't had cancer treatment or experimental therapy in the last 2 weeks or 5 half-lives of the therapy.My brain metastases are stable for 4 weeks and I'm not on steroids.My condition worsened after two standard treatments or I refused them.My cancer can be measured on a CT scan according to specific criteria.I do not have a history of or current retinal vein occlusion, uncontrolled glaucoma, or conditions that increase blood thickness or clotting.My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.You must have at least 100 billion platelets per liter of blood.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (trametinib, hydroxychloroquine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Hydroxychloroquine for medical use?
"Hydroxychloroquine's safety has few data points to support it, so its score is 1 on our team at Power's scale."
Answered by AI
How large is the recruitment pool for this research endeavor?
"Affirmative. The clinical trial database indicates that recruitment for this study is still active. It was initially posted on January 18th 2019 and last modified on October 31st 2022, with the aim of enrolling 33 patients at a single site."
Answered by AI
Is enrollment for this research endeavor still open?
"Affirmative. Clinicaltrials.gov reveals that the trial first posted on January 18th 2019 is actively recruiting patients at present time. 33 participants from 1 site are needed for this venture, which was most recently updated on October 31st 2022."
Answered by AI
Could you please elaborate on other investigations that have been done with Hydroxychloroquine?
"Presently, there are 152 live trials in progress that investigate Hydroxychloroquine's efficacy with 13 of them currently being conducted at a Phase 3 level. Hangzhou, Zhejiang is the site for most of these experiments but 6363 locations worldwide have active studies about this medication."
Answered by AI
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