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PaTcH Trial: A phase 2 study to explore primary and emerging resistance mechanisms in patients with metastatic refractory Pancreatic cancer treated with Trametinib and Hydrochloroquine.
EU CTIS ID: 2024-513429-21-00
What this study is testing
To determine the 12-week progression free survival (PFS) of trametinib and hydroxychloroquine in patients with metastatic refractory pancreatic cancer.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Patients must have normal organ and marrow function as defined below: a. Serum creatinine ≤ 1.5 x ULN. b. Adequate hepatic function defined by: o total bilirubin level ≤ 1.5 × ULN, o 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) c. Hematological eligibility parameters: o Absolute Neutrophil count ≥ 1.5 x 109/L o Platelet count ≥100 x109/L o Hemoglobin ≥ 9 g/dL
You likely can't join if
- 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.
- 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
See the full eligibility criteria
Who can join
- 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
- Patients must have normal organ and marrow function as defined below: a. Serum creatinine ≤ 1.5 x ULN. b. Adequate hepatic function defined by: o total bilirubin level ≤ 1.5 × ULN, o 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) c. Hematological eligibility parameters: o Absolute Neutrophil count ≥ 1.5 x 109/L o Platelet count ≥100 x109/L o 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: 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.
What rules you out
- 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.
- 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
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.