Rechallenge With Panitumumab Driven by RAS Dynamic of Resistance (NCT03227926) | Clinical Trial Compass
CompletedPhase 2
Rechallenge With Panitumumab Driven by RAS Dynamic of Resistance
Italy32 participantsStarted 2017-10-11
Plain-language summary
This is a hypothesis driven, open label, single-arm, multiple centers, Phase II trial. The trial has been designed to prove or disprove whether a rechallenge with panitumumab can achieve an objective response rate (ORR= CR+PR) of 30% or more in a population of RAS wild type mCRC patients selected on the basis of RAS extended clonal evolution in their plasma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed diagnosis of metastatic colorectal cancer;
✓. Age ≥ 18 years;
✓. Written informed consent;
✓. Documented WT RAS exons 2, 3 and 4 (KRas and NRas) and WT BRAF V600E for anti-EGFR treatment.
✓. Complete or partial response to anti EGFR antibodies in any line either received as monotherapy or in combination with chemotherapy;
✓. Imaging documented progression while on therapy with a therapeutic regimen including anti-EGFR mAb;
✓. Imaging documented progression at the last treatment regimen that must be anti-EGFR free;
✓. Patient must be RAS and EGFR ectodomain wild type in a liquid biopsy performed no longer that 4 weeks after progression to the last anti-EGFR free treatment
Exclusion criteria
✕. History of severe infusion reactions to monoclonal antibodies cetuximab or panitumumab;
✕. Symptomatic or untreated leptomeningeal disease and symptomatic brain metastasis;
✕. congestive heart failure requiring treatment (NYHA grade ≥ 2), Left ventricular ejection fraction (LVEF) \< 45% as determined by Multigated acquisition (MUGA) scan or echocardiogram;
What they're measuring
1
Overall response rate (ORR) to panitumumab according to RECIST v1.1.
Timeframe: Tumor assessments every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months