A MolEcularly Guided Anti-Cancer Drug Off-Label Trial (NCT04185831) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A MolEcularly Guided Anti-Cancer Drug Off-Label Trial
Sweden167 participantsStarted 2020-10-20
Plain-language summary
This is a prospective, open-label, non-randomized combined basket- and umbrella trial divided in two parts; a limited feasibility-oriented part 1 including 154 patients and 3 treatment cohorts and part 2 that will include an expanded cohort of patients and treatment cohorts. The overall aims of the study are to test the feasibility, safety and efficacy of comprehensive genomic profiling on fresh tumor biopsies as a basis for treatment decision making and to compare two different sequencing, bioinformatics and decision-making platforms (part 1). Also to evaluate the efficacy and safety of off-label treatment with cancer drugs in patients selected based on genomic biomarker matching.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult (age \>18 years)
✓. Patients with histologically-proven, locally advanced or metastatic solid tumor (part 1; hematological malignancies also eligible in part 2) progressive while on last line established therapy considered available for the patient. For re-recruitment (part 2) patients must be progressive while on trial defined treatment or off-protocol treatment.
✓. Fresh tumor sampling by biopsy must be possible, except for patients with CNS malignancy who can be included based on molecular analysis of archived tumor material.
✓. ECOG performance status 0-2.
✓. Patients must have acceptable organ function as defined below:
. Patients receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates, somatostatin analogues and prednisone, or equivalent, \>5 mg/d). These medications must have been started ≥ 1 week prior to the screening visit on this study. Radiotherapy to non-target lesions is allowed.
✕. Patients pregnant or nursing.
✕. Patients of childbearing potential and sexually active and not willing to use highly effective contraceptive.
✕. Patients with known active progressive CNS metastases. Patients with previously treated CNS metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to inclusion. All patients with previously treated CNS metastases must be stable for at least 1 month after completion of treatment and off steroid treatment prior to inclusion.
✕. Some concomitant diseases qualified for exclusion as detailed in main protocol.
✕. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient to participate in the trial.