Phase I oncology clinical trials are designed to identify the optimal dose that will be recommended for phase II trials. This dose is typically defined as the dose associated with a certain probability of dose limiting toxicity (DLT) during the first cycle of treatment, although toxicity is ...
The primary objective was to determine the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors. Safety, tolerability, and pharmacokinetics (PK) were assessed. Patients were dosed twice weekly intravenously in 9 cohorts (0.5–15.6 mg/kg). Safety was evaluated using CTCAE ...
The key lessons learned from this study is that continuous rucaparib dosing is required for optimal response, the recommended phase 2 dose (RP2D) for continuous oral scheduling has not been established and requires further exploration and, thirdly, the use of a PD biomarker to evaluate dose–...
By contrast, telisotuzumab vedotin in Phase I trials has shown favorable outcomes [91]. Among 48 patients with NSCLC tested, the recommended Phase II dose for telisotuzumab vedotin was defined as 2.7 mg/kg on the basis of overall safety and tolerability. The most frequent telisotuzumab ...
We completed the schedule A phase 1 portion with primary objectives of safety, tolerability, and recommended phase 2 dose (RP2D) using the "3+3" ... KS Sandhu,Q Huynh-Tran,EE Cooper,... - 《Clinical Lymphoma Myeloma & Leukemia》 被引量: 0发表: 2021年 ...
The primary objective was to determine the recommended phase II dose of tasisulam; secondary objectives were to characterize the toxicity and pharmacokinetic profiles of tasisulam and to discern whether there was any antitumor activity [89]. Twenty-six patients were enrolled. No dose-limiting ...
The dose of THAL in this study (50 mg/d) was better tolerated than the higher doses used in previous studies. Adverse events associated with corticosteroid therapy were mild and transient. Clinical responses did not correlate with improvements in either intramedullary fibrosis or angiogenesis. THAL...
The recommended dose of methylprednisolone should not exceed 1–2 mg/kg/day [8, 27, 44]. Gamma globulin for injection For severe and critical cases, of the use gamma globulin can be considered; however, its efficacy remains unclear at present. The recommended dose is 1.0 g/kg/day for 2...
A Phase 2, Multicenter, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ST-617 for the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for Head and Neck Cance,PSI CRO Australia
recommended phase 2 dose of pralsetinib as 400 mg QD10. Adults with unresectable, locally advanced or metastatic solid tumors were enrolled into nine phase 2 groups as defined by disease type and prior therapy status. This current analysis reports results for the subgroup of patients withRET...