Study of Trametinib and Ruxolitinib in Colorectal Cancer and Pancreatic Adenocarcinoma

  • STATUS
    Recruiting
  • End date
    Mar 3, 2023
  • participants needed
    48
  • sponsor
    National Cancer Centre, Singapore
Updated on 3 July 2022
cancer
tyrosine
systemic therapy
measurable disease
gilbert's syndrome
metastasis
neutrophil count
liver metastasis
adenocarcinoma
ki-ras

Summary

The purpose of this research study to find out if the drug trametinib in combination with ruxolitinib is safe, tolerable and has beneficial effects in people who has certain type of cancers including the type that you have. Patients with RAS mutant colorectal cancer and pancreatic adenocarcinoma are invited to participate in this study. This is the first time that both trametinib and ruxolitinib are studied in combination. Trametinib is marketed in several countries with the brand name Mekinist® for the treatment of melanoma (a type of skin cancer). Trametinib has been studied extensively in cancer and has been tested in many patients. Ruxolitinib is an oral inhibitor of JAK1 and JAK2 tyrosine kinases and is approved for treatment of adult polycythemia vera and myelofibrosis. Ruxolitinib has been studied extensively in many patients.

Details
Condition Colorectal Cancer, Pancreatic Adenocarcinoma
Treatment Ruxolitinib, Trametinib
Clinical Study IdentifierNCT04303403
SponsorNational Cancer Centre, Singapore
Last Modified on3 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients (male or female) ≥ 21
Patients with histological diagnosis of RAS mutant advanced colorectal and pancreatic adenocarcinoma having received at least 1 prior line of systemic therapy. Pancreatic cancer patients with KRAS mutation detected on plasma profiling having received at least 1 prior line of systemic therapy
Patients must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1
Life expectancy of at least 3 months
Written informed consent that is consistent with ICH-GCP guidelines
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
Have adequate organ and hematologic function, as determined by
Absolute neutrophil count (ANC) ≥ 1,500/μl
Platelets ≥ 100,000/μl
Haemoglobin ≥ 9g/dL
Aspartate Amino Transferase (AST)/ Alanine Amino Transferase (ALT) ≤ 2.5 x upper limit of normal (ULN ≤ 5 x ULN is acceptable if liver metastases are present)
Total bilirubin ≤1.5 x ULN (< 3 ULN for patients with Gilbert syndrome)
Creatinine clearance ≥ 60ml/min
Prothrombin time and activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range
Ejection fraction ≥ 50% with no symptoms attributable to heart failure
Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT
For female patients of childbearing potential, a negative pregnancy test must be documented prior to enrolment
interval corrected (Fridericia) (QTcF) of ≤450 ms in males or ≤470 ms in
Female and male patients who are fertile must agree to use a highly effective form of contraception with their sexual partners throughout study participation
females
Have the willingness and ability to comply with scheduled visits and study procedures

Exclusion Criteria

Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days of study drug commencement, or 5 half-lives, whichever is shorter, and with recovery of clinically significant toxicities from that therapy
Received monoclonal antibodies or had surgery within 30 days of the first dose of study drug
Have been diagnosed with another primary malignancy within the past 3 years of study drug commencement (except for adequately treated non-melanoma skin cancer, cervical cancer in situ, or prostate cancer)
Have CNS metastases that are symptomatic, neurologically unstable, or requiring an increasing dose of corticosteroids
Have meningeal involvement or spinal cord compression
Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to
Myocardial infarction (MI) within 6 months prior to the first dose
Unstable angina within 6 months prior to first dose
History of congestive heart failure (CHF)
History of clinically significant atrial arrhythmia
Any history of ventricular arrhythmia
Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose
Have an ongoing or active infection
Patients with active HBV and HCV are excluded unless they are undergoing treatment for HBV and HCV
Have history or the presence of pulmonary interstitial disease or drug related
Have a history of or active significant gastrointestinal (GI) bleeding within 3 months of the first dose
pneumonitis
Patients who are on immunosuppressive therapy
Patients who have retinal vein occlusion and retinal pigment epithelial detachment
On medications which are potent and moderate inhibitor and inducers of CYP3A4
Patients with moderate to severe hepatic impairment (Child Pugh B and C)
Patients with history of severe allergic skin reactions or current skin conditions
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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