None listed
Conditions
Brief summary
This study aims to screen patients with advanced cancer and unmet clinical needs for actionable biomarkers to be used to guide therapy. Who is it for? You may be eligible to join this study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any cell type or an earlier diagnosis of a poor prognosis cancer and have received all standard anticancer therapy. Study details: A small part of your tumour tissue, which was collected from a previous biopsy or surgery, will be used to identify a biomarker by doing a laboratory analysis (‘molecular screening’). The screening includes genetic panel testing, which means looking for changes in a subset of genes (DNA) in your tumour tissue and other laboratory assays. You will be asked to provide information about your and your family’s health background, to donate a blood sample and complete some questionnaires. Results from molecular screening will be returned to all participants. These results may have implications for your treatment if a suitable biomarker is found.
Interventions
Molecular screening for actionable biomarkers to be used to guide therapy.
Hospital archival tumour tissue will be collected for molecular screening after participant consent and assessment of suitability for the study.
The Garvan Institute of Medical Research will coordinate the molecular screening from archival tumour tissue. The core assays will be based on a genomic sequencing panel to cover a broad range of potentially actionable or biologically important cancer genes, with subsequent bioi
Molecular screening for actionable biomarkers to be used to guide therapy. Hospital archival tumour tissue will be collected for molecular screening after participant consent and assessment of suitability for the study. The Garvan Institute of Medical Research will coordinate the molecular screening from archival tumour tissue. The core assays will be based on a genomic sequencing panel to cover a broad range of potentially actionable or biologically important cancer genes, with subsequent bioinformatics analysis. Patient tumour samples will also be assessed for biomarkers using relevant assays such as immunohistochemistry. Molecular screening results will be reviewed by a Molecular Tumour Board. Options for treatment as a result of the screening will fall into 3 categories: 1. A MoST program clinical trial 2.A clinical trial outside of the program 3. Other treatments outside of the MoST program at the discretion of the participant's clinician All participants, including those with no ‘actionable’ biomarkers, will be informed of the results of the screening of their tumour tissue through their clinician.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria - Molecular Screening 1. Male or female patients, aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any histologic type or an earlier diagnosis of a poor prognosis cancer; 2. Sufficient and accessible tissue for molecular screening; 3. Patients receiving their last line of standard treatment or who have received and failed all standard anticancer therapy (where standard therapy exists) or have documented unsuitability for any further standard anticancer therapy. Poor prognosis cancers or cancers with low expected response rate to standard treatment (in the opinion of the investigator and based on available evidence) may be screened on an earlier line of treatment. a. Failure is defined as either progression of disease (clinical or radiological) or intolerance to standard therapy resulting in the discontinuation of the therapy. b. Documented unsuitability for further standard therapy includes known hypersensitivity, organ dysfunction or other patient factors that would make therapy unsuitable in the judgement of the responsible investigator; 4. ECOG performance status 0, 1 or 2; 5. Willing and potentially able to comply with study requirements, including treatment, timing and/or nature of required assessments; It is the intention to screen patients who are in principle wishing to take part in a MoST substudy if they are found to have an appropriate tumour biomarker and are still eligible for enrolment at the time of the treatment phase; 6. Signed, written informed consent to participation in the molecular screening Inclusion Criteria - Treatment sub-study To be eligible for treatment in a substudy, patients must continue to meet all of the inclusion criteria and none of the exclusion criteria specified for entry into molecular screening at the time of registration to a treatment substudy. In addition, they must meet all the inclusion criteria and none of the exclusion criteria specified for entry into a treatment substudy. 1. Confirmation of molecular eligibility by the molecular tumour board; 2. Received and failed all standard anticancer therapy or have documented unsuitability for any further standard therapy, if standard therapy exists; 3. Clinical or radiological progression on or following last anticancer therapy; 4. Adequate organ system function as assessed per the protocol 5. Meet any additional inclusion criteria specified in the relevant substudy addendum; 6. Signed, written informed consent to participation in the specific treatment substudy.
Exclusion criteria
Exclusion criteria - Molecular Screening 1. Suitable for standard therapy or accepted standard care, if the patient has not been previously treated; 2. Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may contraindicate participation and/or interact with the investigational product(s); 3. Other co-morbidities or conditions that may compromise assessment of key outcomes or in the opinion of the clinician, limit the ability of the patient to comply with the protocol; 4. For non central nervous system (CNS) cancers, patients with symptomatic CNS involvement of his/her cancer. Subjects with stable neurological function ,on stable doses of steroids/anti-epileptics over 4 weeks, and with no evidence of CNS progression within 12 weeks prior to study entry are eligible; 5. History of another malignancy within 2 years prior to registration unless adequately treated and determined free of progressive and metastatic disease for at least 6 months. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible; 6. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a barrier method of contraception (double barrier, if required). Exclusion criteria - Treatment Sub-study Exclusion criteria will include those relevant for screening but also include: 1. Contraindications to investigational product, as listed in the substudy addendum and outlined in the Investigator Brochure appended to each substudy module; 2. Known history of hypersensitivity to active or inactive components of investigational product; 3. Previous treatment with the same agent or same class of agent; 4. Treatment with any of the following anti-cancer therapies prior to the first dose of study treatment: o Radiation therapy, surgery or tumour embolization within 14 days prior to the first dose of study treatment. Palliative radiotherapy (for analgesia) is acceptable only if the irradiated field does not include target lesions; o Immunotherapy within 28 days prior to the first dose of study treatment; o Chemotherapy, biologic therapy, or hormonal therapy within 14 days or 5 half-lives of a drug prior to the first dose of study treatment or until recovery from previous therapy (whichever is longer); 5. Administration of any investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study treatment; 6. Any additional exclusion criteria specified in the relevant substudy addendum.
Outcome results
None listed