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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

Must not have

Subjects who have undergone major surgery =< 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure

History of active major bleeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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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.

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My kidneys work well enough, with a creatinine clearance of at least 30 mL/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had major surgery less than 3 weeks ago or am still dealing with its side effects.

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I have had a major bleeding event in the past.

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My brain metastases are stable for 4 weeks and I'm not on steroids.

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I do not have a history of or current retinal vein occlusion, uncontrolled glaucoma, or conditions that increase blood thickness or clotting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of dose-limiting toxicities during the DLT assessment window.

Secondary study objectives

Incidence of adverse events (AEs) for the duration of study treatment

Response Rate

Side effects data

From 2016 Phase 3 trial • 217 Patients • NCT02057250

13%

Upper respiratory tract infection

Neutropenia

Sinusitis

Alanine aminotransferase increased

Urinary tract infection

Injection site erythema

Accidental overdose

Bronchitis

Injection site pruritus

Thrombocytopenia

Nasopharyngitis

Contusion

Arthralgia

Wolff-Parkinson-White syndrome

Coronary artery occlusion

Anaemia

Leukopenia

Lumbar spinal stenosis

Transient ischaemic attack

Vertebrobasilar insufficiency

Chronic obstructive pulmonary disease

Small intestinal obstruction

Nephrolithiasis

Cataract

Thrombophlebitis superficial

Vomiting

Endometrial hyperplasia

Traumatic arthritis

Hypertension

Pneumonia

Pancreatic carcinoma metastatic

Osteoarthritis

Rheumatoid lung

Pharyngitis

Femoral neck fracture

100%

80%

60%

40%

20%

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1630

Hydroxychloroquine

2017

Completed Phase 4

~4070