The Cancer Molecular Screening and Therapeutics (MoST) Program-Screening
- Conditions
- CancerCancer - Any cancer
- Registration Number
- ACTRN12616000908437
- Lead Sponsor
- niversity of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 7628
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 - 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:
oRadiation 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;
oImmunotherapy within 28 days prior to the first dose of study treatment;
oChemotherapy, 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate a mechanism for screening patients for actionable biomarkers used to guide therapy by measuring a combination of factors (identified individually as secondary outcomes)<br><br><br><br>[ For the duration of the study. estimated at 4 years. The outcomes will be reviewed regularly and at least annually.]
- Secondary Outcome Measures
Name Time Method