Phase I clinical tolerance trial of recombinant human Apo-2 ligand in patients with advanced cancer
Feng-yi Feng · Zhongguo xin yao zazhi · 2007
Objective: To assess the safety of recombinant human Apo-2 ligand(rh-Apo2L) in patients with advanced cancer.Methods: Twenty-two patients with advanced cancer who were negative to intradermal allergy test were intravenously infused with a cohort escalating doses of rh-Apo2L over 2 hours daily for 14 days.Cohorts of three or six patients were accrued to six dosing of rh-Apo2L from 10 to 300 μg·kg-1·d-1 based on plus 3 principle.Results: Two out of 22 patients were screen failure due to a positive reaction to the intradermal allergy test.The major incidences of adverse reactions of rh-Apo2L included grade Ⅲ system inflammatory reaction,and gradeⅠ/Ⅱfever,fatigue,debility,skin or mucosa alteration,GI dysfunction,cardiovascular system toxicity,myelosuppression,hepatic or renal dysfunction.All adverse reactions could be recovery in 2 weeks after termination of the last dose.Maximally tolerated dose(MTD)was 200 μg·kg-1·d-1.Conclusion: The intravenous rh-Apo2L with appropriate safety profile in patients with advanced cancer is recommended further to conduct a phase Ⅱclinical trial.