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- Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
A multicenter phase 1-2a clinical study of Orotecan (oral irinotecan HCl, VAL-413) in patients with recurrent pediatric solid tumors (Section 48) - Mar 5, 2024 - Abstract #AACR2024AACR_3858;
Abstract is embargoed at this time.
- | Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
Trial completion date, Trial primary completion date: Flavored, Oral Irinotecan VAL-413 (Orotecan (clinicaltrials.gov) - Aug 14, 2023
P1, N=20, Recruiting, Sponsor: Valent Technologies, LLC
Abstract is embargoed at this time. Trial completion date: Sep 2023 --> Jun 2024 | Trial primary completion date: Sep 2023 --> Jun 2024
- Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
A pilot clinical study of oral irinotecan HCl (VAL-413) in patients with recurrent pediatric solid tumors. (On Demand | Hall A; Poster Bd # 375b) - Apr 26, 2023 - Abstract #ASCO2023ASCO_4079;
P1
This trial is ongoing (CT.gov: NCT04337177), with no DLT observed to date. Clinical trial information: NCT04337177.
- Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
A pilot clinical study of orotecan (oral irinotecan HCl, VAL-413) in patients with recurrent pediatric solid tumors (Section 46; Poster Board #23) - Mar 14, 2023 - Abstract #AACR2023AACR_4833;
P1
A palatability survey instrument will assess palatability of VAL-413 vs. IRN-IVPO; comparative intrapatient pharmacokinetics of irinotecan and its metabolites will be assessed. This trial is ongoing (CT.gov: NCT04337177), with no DLT observed to date.
- | Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
Trial completion date, Trial primary completion date: Flavored, Oral Irinotecan VAL-413 (Orotecan (clinicaltrials.gov) - Oct 13, 2022
P1, N=20, Recruiting, Sponsor: Valent Technologies, LLC
This trial is ongoing (CT.gov: NCT04337177), with no DLT observed to date. Trial completion date: Nov 2022 --> Sep 2023 | Trial primary completion date: Nov 2022 --> Sep 2023
- Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
A pilot clinical study of VAL-413 (oral irinotecan HCl) in patients with recurrent pediatric solid tumors. (Available On Demand; 274b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3830;
P1
This trial is ongoing (CT.gov: NCT04337177). Enrolment of the first dose level is ongoing, with no DLT observed to date.
- Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
A pilot clinical study of VAL-413 (Orotecan®, oral irinotecan HCl) in patients with recurrent pediatric solid tumors (Section 35) - Mar 9, 2022 - Abstract #AACR2022AACR_5903;
Up to 17 cycles of treatment may be administered on this study.Outcome Measures: Toxicity is assessed by NCI CCTCAEv5; tumor response is assessed by RECIST 1.1. A palatability survey instrument will assess palatability of VAL-413 vs. IRN-IVPO; and comparative intrapatient pharmacokinetics of irinotecan and its metabolites will be assessed in all patients.
- || Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
Enrollment open: Flavored, Oral Irinotecan VAL-413 (Orotecan (clinicaltrials.gov) - Oct 31, 2021
P1, N=20, Recruiting, Sponsor: Valent Technologies, Inc.
A palatability survey instrument will assess palatability of VAL-413 vs. IRN-IVPO; and comparative intrapatient pharmacokinetics of irinotecan and its metabolites will be assessed in all patients. Not yet recruiting --> Recruiting
- | Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
Trial completion date, Trial primary completion date: Flavored, Oral Irinotecan VAL-413 (Orotecan (clinicaltrials.gov) - Sep 23, 2021
P1, N=20, Not yet recruiting, Sponsor: Valent Technologies, Inc.
Not yet recruiting --> Recruiting Trial completion date: Dec 2021 --> Nov 2022 | Trial primary completion date: Dec 2021 --> Nov 2022
- irinotecan / Generic mfg.
[VIRTUAL] A pilot clinical trial of Orotecan (Val-413), a novel oral dosage formulation of irinotecan: Implications for pediatric brain tumors () - Oct 24, 2020 - Abstract #SNO2020SNO_405;
P1
Toxicity is evaluated based on CTCAEv5 and tumor response based on RECISTv1.1. An update on the progress of this trial will be presented.
- leucovorin calcium / Generic mfg., fluorouracil / Generic mfg., Onivyde (nanoliposomal irinotecan) / Ipsen, PharmaEngine, Takeda, Servier
[VIRTUAL] Differentiation of liposomal irinotecan from dose-dense non-liposomal irinotecan in patient-derived pancreatic cancer xenograft tumor models. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_4198;
N = 8 mice/group; aN = 4 mice. Collected b24 and c25 hours post-injection of third treatment cycle.
- irinotecan oral (VAL-413) / Valent Technologies, irinotecan / Generic mfg.
[VIRTUAL] A pilot pharmacokinetic study of VAL413 in patients with recurrent pediatric solid tumors (Virtual Meeting: All Session Times Are U.S. EDT) - Apr 13, 2020 - Abstract #AACRI2020AACR-I_137;
The evaluation of two dose levels will help to formally define a recommended Phase II dose for further studies. Toxicity will be evaluated based on CTCAEv5 and tumor response based on RECISTv1.1.
- | Orotecan (irinotecan oral) / Valent Tech, Edison Oncology
New P1 trial: Flavored, Oral Irinotecan VAL-413 (Orotecan (clinicaltrials.gov) - Apr 6, 2020
P1, N=20, Not yet recruiting, Sponsor: Valent Technologies, Inc.
- irinotecan oral (VAL-413) / Valent Technologies
High frequency of plasmid-mediated colistin resistance genes in Enterobacteriaceae veterinary isolates in Portugal (2010-2015) () - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_2000;
Selection pressure exerted by broad-spectrum cephalosporins and other antimicrobials may select and enhance the rapid dissemination of PMCR, e.g. the new mcr-1.9 positive isolate co-harbouring a blaCTX-M-8 gene. Globally, these results seem alarming in terms of public health evidencing that surveillance of this colistin resistance mechanism should continue, namely in other reservoirs (humans and environment), emphasizing the importance of the One Health perspective.