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Clinical Trial Record

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PaTcH Study: A Phase 2 Study of Trametinib and Hydroxychloroquine in Patients With Metastatic Refractory Pancreatic Cancer

2023-05-31

2025-09-30

2026-06-30

22

Study Overview

PaTcH Study: A Phase 2 Study of Trametinib and Hydroxychloroquine in Patients With Metastatic Refractory Pancreatic Cancer

This study is designed to investigate the means by which cancer resists treatment can be overcome by a combination of an established anticancer drug, trametinib, with hydroxychloroquine.

The study is a multi-centre single arm Phase 2 clinical trial to explore primary and emerging resistance mechanisms in patients with metastatic refractory pancreatic cancer treated with trametinib and hydroxychloroquine. This study will include 10-22 patients with metastatic pancreatic cancer who have previously progressed on at least one line of systemic therapy.

  • Pancreatic Cancer
  • DRUG: Trametinib
  • DRUG: Hydroxychloroquine
  • CTRIAL-IE 20-27
  • 2021-006276-16 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

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

2022-07-22  

N/A  

2024-09-25  

2022-08-24  

N/A  

2024-09-26  

2022-08-26  

N/A  

2024-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: PaTcH

All eligible patients will be treated with trametinib 2mg and hydroxychloroquine 1200mg daily (600mg twice a day (BID)) orally. Treatment will be continuous in treatment cycles lasting 28 days, and will continue until radiological or clinical progression

DRUG: Trametinib

  • 2mg of Trametinib (orally) daily.

DRUG: Hydroxychloroquine

  • 1200mg of Hydroxychloroquine (orally; 600mg twice a day (BID)) daily.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Patients free of disease progressionThe percentage of patients free of disease progression at 12 weeks from starting treatment into the study as determined by radiographic disease assessments per RECIST version 1.1.Twelve weeks from starting treatment.
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Tumour Response RateConfirmed tumour response rate as assessed by RECIST version 1.1.Twelve weeks following the 15th and 22nd patients.
Duration of ResponseConfirmed duration of response as assessed by RECIST version 1.1.Through study treatment, an average of 1 year
Overall SurvivalOverall SurvivalThrough study completion, an average of five years
Safety and tolerabilityThe safety and tolerability of this regimen as measured by incidence of adverse events reported and toxicity evaluation as per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.Through study treatment, an average of one year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Cancer Trials Ireland

Phone Number: +353 (0) 1 6677211

Email: info@cancertrials.ie

Participation Criteria

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:

    Inclusion Criteria:
    Each patient must meet all of the following inclusion criteria to be eligible for the study:
    1. Patients must have pathologically confirmed advanced metastatic pancreatic adenocarcinoma or poorly differentiated pancreatic adenocarcinoma that is amenable to tumour biopsy. 2. Patients have received at least one line of systemic therapy for metastatic disease and not be amenable to surgical resection. 3. Patients must have measurable disease by RECIST 1.1 criteria. 4. Age ≥18 years. 5. ECOG performance status ≤ 1 6. Patients must have normal organ and marrow function as defined below:
    1. Serum creatinine ≤ 1.5 x ULN. 2. Adequate hepatic function defined by:

  • total bilirubin level ≤ 1.5 × ULN,
  • an AST, level ≤ 2.5 × ULN, and an ALT level ≤ 2.5 × ULN (or, for subjects with documented metastatic disease to the liver, AST and ALT levels ≤ 5 × ULN) 3. Hematological eligibility parameters:


  • Absolute Neutrophil count ≥ 1.5 x 109/L
  • Platelet count ≥100 x109/L
  • Hemoglobin ≥ 9 g/dL 7. Ability of subject to understand and the willingness to sign a written informed consent document. 8. Women of child-bearing potential or sexually active males must agree to use highly effective contraceptive measures. This applies from starting treatment until at least 16 weeks after the last study drug administration. The investigator or a designated associate is required to advise the patient how to achieve an adequate birth control. Highly effective contraception is defined in the study as methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include:

    • I. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal). II. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable and implantable). III. Intrauterine device (IUD). IV. Intrauterine hormone-releasing system (IUS). V. Bilateral tubal occlusion. VI. Successfully vasectomised partner. VII. Sexual abstinence.
    Exclusion Criteria:
    Patients are excluded from the study if any of the following exclusion criteria apply:
    1. Persisting toxicity related to prior therapy (CTCAE Grade > 1); however alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤2 AEs not constituting a safety risk based on investigator's judgment are acceptable. 2. Prior treatment with a MEK inhibitor 3. Known history of testing positive for Human Immunodeficiency Virus (HIV) or known acquired immunodeficiency syndrome. 4. Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment. 5. Patients who are receiving any other investigational agents within 28 days before start of study treatment. 6. Prior organ transplantation including allogenic stem-cell transplantation. 7. Patients with known central nervous system metastases. 8. Active uncontrolled infection, requiring systemic therapy. 9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. 10. Severe left ventricular dysfunction as defined by ejection fraction < 45% 11. Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 12. Known maculopathy of the eye 13. Known history or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) 14. Screening corrected QT interval by Fridericia (QTcF) > 500 msec 15. Pregnant women and breastfeeding mothers are excluded due to unknown impact on embryos or infants 16. Known prior severe hypersensitivity to investigational products or any component in its formulation. 17. Concurrent use of medicines known to induce retinal toxicity (e.g. tamoxifen) or QT interval prolonging agents. 18. Known congenital or documented acquired QT prolongation. 19. Uncorrected hypokalemia and/or hypomagnesemia.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Novartis
  • PRINCIPAL_INVESTIGATOR: Austin Duffy, Mater Misericordiae University Hospital

Publications

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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