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Tag: dose escalation

Pharmacokinetics and safety of intravenously administered citrulline in children undergoing congenital heart surgery: potential therapy for postoperative pulmonary hypertension

This study evaluated the safety and pharmacokinetics of intravenous citrulline in infants and children undergoing congenital heart surgery. In Phase 1, a dose-escalation protocol (50, 100, 150 mg/kg) was used, with a target plasma citrulline trough of 80–100 µmol/L. The 150 mg/kg dose achieved this target. Due to citrulline’s short

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June 26, 2025 No Comments

Phase I trial of intravenous aviscumine (rViscumin) in patients with solid tumors: a study of the European Organization for Research and Treatment of Cancer New Drug Development Group

This 2004 Phase I clinical trial investigated the safety, pharmacokinetics, and preliminary efficacy of intravenous aviscumine (rViscumin), a recombinant mistletoe lectin, in 41 patients with advanced solid tumors refractory to standard therapies. Doses ranged from 10 to 6400 ng/kg, administered twice weekly. Dose-limiting toxicities included fatigue and reversible grade 3

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June 26, 2025 No Comments

Trial of Mistletoe Extract in Patients With Advanced Solid Tumors

This Phase I clinical trial (NCT03051477) evaluates the safety, toxicity, and maximum tolerated dose (MTD) of Helixor® M (mistletoe extract) in 21 patients with advanced solid tumors who have not responded well to first-line therapies. The study consists of a dose escalation phase to assess safety and an expansion phase

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June 26, 2025 No Comments

Mistletoe Plant Extract in Patients With Nonmuscle Invasive Bladder Cancer: Results of a Phase Ib/IIa Single Group Dose Escalation Study

This 2015 Phase Ib/IIa single-group dose escalation study (Journal of Urology, PMID: 25910967) investigated the safety, tolerability, and preliminary efficacy of intravesical mistletoe (Viscum album) extract in 36 patients with nonmuscle invasive bladder cancer (NMIBC). Following tumor resection, patients received weekly intravesical instillations of mistletoe extract for six weeks. At

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June 26, 2025 No Comments