Study design
tumor, Tumor, toxicity, PD, a malignant disease
DISEASE, TUMOR, RECRUITMENT, TUMOR
ProTarget is a Danish nationwide, interventional, multi-drug, open-label, pan-cancer, non-randomized, prospective phase 2 basket trial which aims to investigate the efficacy and safety of targeted anticancer drugs when used off-label in patients with a malignant disease harboring an actionable genomic alteration. Patients are recruited from eight different investigator sites at oncological centers. The trial aims to include 100 pts. annually.Patients are identified through local genomic testing at each investigator site (Fig. ProTarget Study Schema. Potentially eligible pts. are identified by local tumor genomic testing at each site. The investigator presents the genomic profile and clinical history and status of the patient and proposes the drug-variant match. If confirmed by the DN-MTB, the pt. can sign drug-specific informed consent and enter screening. Patients failing screening may be re-assessed for another drug if relevant. Patients meeting all eligibility criteria will start treatment. Fresh biopsies are taken at screening, on-treatment and at PD. Liquid biopsies are taken at screening and at CXD1 before dosing. Treatment is continued until PD or unmanageable toxicity. The pt. may be re-assessed for another drug if a matching alteration exists. *MTB may include as treatment options: A) Confirmation of ProTarget drug-variant-match, B) Treatment of an alternate ProTarget genomic alteration, C) Treatment of non-ProTarget variant on/off protocol or off-label, D) No treatment/protocol available. ** Every 8 weeks for 24 weeks, then every 12 weeks. Abbreviations: DN-MTB: Danish National Molecular Tumor Board, ctDNA: circulating tumor DNA, C1D1: cycle one day one, CXD1: any cycle day one, CR: complete response, PR: partial response, SD: stable disease, PD: progressive diseaseGeneral inclusion criteriaGeneral exclusion criteriaPatient recruitment began 24-Aug-2020 and is ongoing. Last patient, last visit is undefined, and cohorts will open and reach completion successively depending on variant identification in individual pts.