A randomised, open-label, multi-centre, two-arm Phase 3 study comparing futuximab/modotuximab in combination with trifluridine/tipiracil to trifluridine/tipiracil single agent with a Safety Lead-In part in participants with KRAS/NRAS and BRAF wild type metastatic colorectal cancer previously treated with standard treatment and anti-EGFR therapy (COLSTAR) - COLSTAR

Institut de Recherches Internationales Servier0 个研究点目标入组 500 人开始时间: 2021年9月29日最近更新: 2023年8月28日

适应症

试验速览

暂无简介。

•- Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC), not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumour
•Without RAS (KRAS and NRAS) and BRAF V600E mutations based on Circulating tumour DNA (ctDNA) screening blood test analysis
•- Participants with measurable or non-measurable lesion
•- Participants must have received at least 2 prior regimens of standard chemotherapy for mCRC and had demonstrated progressive disease or intolerance to their last regimen
•- Participants should have received previous treatment with commercially available anti-EGFR mAbs for = 16 weeks.
•- Estimated life expectancy = 12 weeks
•- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•- Adequate haematological function
•- Adequate renal function
•- Adequate hepatic function
•- Serum potassium, serum phosphates, serum magnesium within normal limits
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 275
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 225

•- Pregnancy, possibility of becoming pregnant during the study, breast-feeding woman
•- Patients currently receiving or having received anticancer therapies within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Randomised part)
•- Major surgery within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Randomised part) or participants who have not recovered from side effects of the surgery
•- Participants with serious/active/uncontrolled infection
•- Known clinically significant cardiovascular disease or condition
•- Significant gastrointestinal abnormality
•- Skin rash of Grade > 1 from prior anti-EGFR at the time of inclusion (Safety Lead-in part) or randomization (Randomised Phase 3 part), or any other skin toxicity precluding participation in the study according to investigator's discretion
•- Treatment with systemic immunosuppressive therapy within 4 weeks prior to inclusion (Safety Lead-in part) or randomization (Randomised part)
•- Prior radiotherapy if completed less than 4 weeks before the inclusion visit (Safety Lead-in part) or randomization visit (Randomised part)
•- Patients with other malignancies

发起方