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Pancreatic CancerPhase 2PaTcHNCT05518110

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

A Phase 2 study testing Trametinib and Hydroxychloroquine in people with Pancreatic Cancer, run by Cancer Trials Ireland at 2 sites in Ireland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Trametinib and Hydroxychloroquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesIreland
Study dates
31 May 2023to 3 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each patient must meet all of the following inclusion criteria to be eligible for the study:
  • Patients must have pathologically confirmed advanced metastatic pancreatic adenocarcinoma or poorly differentiated pancreatic adenocarcinoma that is amenable to tumour biopsy.
  • Patients have received at least one line of systemic therapy for metastatic disease and not be amenable to surgical resection.
  • Patients must have measurable disease by RECIST 1.1 criteria.
  • Age ≥18 years.
  • ECOG performance status ≤ 1
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  • Patients must have normal organ and marrow function as defined below:
  • Serum creatinine ≤ 1.5 x ULN.
  • 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)
  • Hematological eligibility parameters:
  • Absolute Neutrophil count ≥ 1.5 x 109/L
  • Platelet count ≥100 x109/L
  • Hemoglobin ≥ 9 g/dL
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • 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:
  • 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.

Who cannot join

  • Patients are excluded from the study if any of the following exclusion criteria apply:
  • 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.
  • Prior treatment with a MEK inhibitor
  • Known history of testing positive for Human Immunodeficiency Virus (HIV) or known acquired immunodeficiency syndrome.
  • Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
  • Patients who are receiving any other investigational agents within 28 days before start of study treatment.
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  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Patients with known central nervous system metastases.
  • Active uncontrolled infection, requiring systemic therapy.
  • 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.
  • Severe left ventricular dysfunction as defined by ejection fraction < 45%
  • 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.
  • Known maculopathy of the eye
  • 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)
  • Screening corrected QT interval by Fridericia (QTcF) > 500 msec
  • Pregnant women and breastfeeding mothers are excluded due to unknown impact on embryos or infants
  • Known prior severe hypersensitivity to investigational products or any component in its formulation.
  • Concurrent use of medicines known to induce retinal toxicity (e.g. tamoxifen) or QT interval prolonging agents.
  • Known congenital or documented acquired QT prolongation.
  • Uncorrected hypokalemia and/or hypomagnesemia.

Trial locations and contacts

2 sites in 1 country.

Ireland2 sites

  • Mater Misericordiae University Hospital

    Dublin, D07 R2WY

  • St Vincent's University Hospital

    Dublin, DO4 T6F4

Other trials in Ireland

About this study

Official title: PaTcH Trial: A Phase 2 Study to Explore Primary and Emerging Resistance Mechanisms in Patients With Metastatic Refractory Pancreatic Cancer Treated With Trametinib and Hydroxychloroquine

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.

Read the detailed description

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.

Being tested
Trametinib, Hydroxychloroquine
Keywords
Metastatic refractory, Primary and emerging resistance mechanisms
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrametinibDrug

    2mg of Trametinib (orally) daily.

  • HydroxychloroquineDrug

    1200mg of Hydroxychloroquine (orally; 600mg twice a day (BID)) daily.

Study groups in NCT05518110
Study groupRoleWhat they receive
PaTcHExperimentalAll 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 of disease, unacceptable toxicity or consent withdrawal.
Receives: Drug: Trametinib; Drug: Hydroxychloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients free of disease progression

    The 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.

    Measured: Twelve weeks from starting treatment.

Secondary outcomes (4)

  1. Tumour Response Rate

    Confirmed tumour response rate as assessed by RECIST version 1.1.

    Measured: Twelve weeks following the 15th and 22nd patients.

  2. Duration of Response

    Confirmed duration of response as assessed by RECIST version 1.1.

    Measured: Through study treatment, an average of 1 year

  3. Overall Survival

    Overall Survival

    Measured: Through study completion, an average of five years

  4. Safety and tolerability

    The 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.

    Measured: Through study treatment, an average of one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2022
  2. Study start31 May 2023
  3. Primary completion3 Mar 2026
  4. Study completion3 Mar 2026

Why it stopped: Study terminated due to futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05518110
Sponsor's protocol ID
CTRIAL-IE 20-27
Other IDs
2021-006276-16
Acronym
PaTcH
Status last verified
Apr 2026
First submitted
22 Jul 2022
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pseudo-anonymised biological samples will be shared with the University College of Dublin for performance of the translational sub-study throughout the study.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trametinib and Hydroxychloroquine in people with Pancreatic Cancer, run by Cancer Trials Ireland at 2 sites in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to futility). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients free of disease progression (time frame: Twelve weeks from starting treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05518110.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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