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- Title
Phase II clinical trial of PM00104 (Zalypsis) in urothelial carcinoma patients progressing after first-line platinum-based regimen.
- Authors
Castellano, Daniel; Bellmunt, Joaquim; Maroto, José; Font-Pous, Albert; Morales-Barrera, Rafael; Ghanem, Ismael; Suarez, Cristina; Martín Lorente, Cristina; Etxaniz, Olatz; Capdevila, Laia; Coronado, Cinthya; Alfaro, Vicente; Siguero, Mariano; Fernández-Teruel, Carlos; Carles, Joan
- Abstract
Purpose: This exploratory phase II clinical trial evaluated the antitumor activity, safety profile and pharmacokinetics of PM00104 (Zalypsis) 3 mg/m 1 h every 3-week intravenous infusion in patients with advanced and/or metastatic urothelial carcinoma progressing after first-line platinum-based chemotherapy. Methods: The primary efficacy end point was the disease control rate (DCR), defined as the percentage of patients with confirmed objective response or progression-free at 3 months, according to the response evaluation criteria in solid tumors. Results: In a first stage ( n = 19 patients evaluable for efficacy), only one patient achieved DCR (stable disease as best response and progression-free survival of 3.1 months). According to the 2-stage design used, the primary efficacy objective was unmet, and therefore, the trial was finalized without opening the second stage. The most common adverse events related to PM00104 were fatigue, anorexia, nausea, troponin I increase and neutropenia, which were transient and manageable with dose modifications or administration delays. Mean PK results ( C = 48.57 μg/l and area under the curve (AUC) = 154.97 h μg/l) were similar to those observed in a previous phase I trial evaluating the same dose and schedule. Few troponin I concentrations were higher than 0.10 ng/ml, and none of them were related to parameters of PM00104 exposure such as AUC or C. Conclusions: No recommendation is given for further evaluation of PM00104 as single-agent treatment of patients with pretreated advanced and/or metastatic urothelial carcinoma. No new safety signals were observed.
- Subjects
TRANSITIONAL cell carcinoma; CLINICAL trials; URINARY organ cancer; CANCER invasiveness; PHYSIOLOGICAL effects of platinum; ANTINEOPLASTIC agents; PHARMACOKINETICS; MEDICATION safety; CANCER chemotherapy; PATIENTS; THERAPEUTICS
- Publication
Cancer Chemotherapy & Pharmacology, 2014, Vol 73, Issue 4, p857
- ISSN
0344-5704
- Publication type
Report
- DOI
10.1007/s00280-014-2419-7