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Spots Global Cancer Trial Database for A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

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Trial Identification

Brief Title: A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

Official Title: MEGALiT - a Multicenter, Basket and Umbrella Explorative Trial on the Efficacy and Safety of Molecular Profile Selected Commercially Available Targeted Anti-cancer Drugs in Patients With Advanced Cancers Progressive on Standard Therapy

Study ID: NCT04185831

Conditions

Solid Tumor

Study Description

Brief 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.

Detailed Description: 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 (mutation/drug) 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sahlgrenska University Hospital, Gothenburg, , Sweden

Skane University Hospital, Lund, , Sweden

Uppsala University Hospital, Uppsala, , Sweden

Contact Details

Name: Peter Nygren, MD, PhD

Affiliation: Uppsala University Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Peter Asplund, BSc

Affiliation: Uppsala University Hospital

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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