A MolEcularly Guided Anti-Cancer Drug Off-Label Trial
NCT04185831 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167
Last updated 2024-08-22
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.
Conditions
Interventions
- DRUG
-
PD-L1 inhibitor
- DRUG
-
MTOR inhibitor
- DRUG
-
Cobimetinib
MEK inhibitor
- DRUG
-
Niraparib
PARP inhibitor
Sponsors & Collaborators
-
Uppsala University Hospital
lead OTHER
Principal Investigators
-
Peter Nygren, MD, PhD · Uppsala University Hospital
-
Peter Asplund, BSc · Uppsala University Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-20
- Primary Completion
- 2024-01-31
- Completion
- 2024-10-31
Countries
- Sweden
Study Locations
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