A Phase 1 study of BAL101553, a novel tumor checkpoint controller targeting microtubules, administered as 48-h infusion in adult patients with advanced solid tumors.
BAL101553
Chemotherapy
Microtubule-targeting agent
Ovarian cancer
Journal
Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
received:
10
07
2019
accepted:
21
08
2019
pubmed:
1
9
2019
medline:
10
9
2021
entrez:
1
9
2019
Statut:
ppublish
Résumé
Purpose BAL101553, the prodrug of the microtubule-destabilizer BAL27862, previously showed signs of antitumor activity when administered as a 2-h infusion, but its use was limited by vascular toxicity. We investigated an alternative dosing strategy aimed at improving the safety profile of BAL101553. Methods This multicenter, open-label, Phase 1 dose-escalation study used a 3 + 3 design to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), pharmacokinetics, and antitumor activity of BAL101553 administered as a 48-h IV infusion on Days 1, 8, and 15 of a 28-day cycle. Patients received oral BAL101553 on Days 15-21 of cycle 2 to assess oral bioavailability. Results BAL101553 was well tolerated at doses up to ≤70 mg/m
Identifiants
pubmed: 31471863
doi: 10.1007/s10637-019-00850-z
pii: 10.1007/s10637-019-00850-z
pmc: PMC7340672
doi:
Substances chimiques
Antineoplastic Agents
0
BAL27862
0
Benzimidazoles
0
Oxadiazoles
0
Prodrugs
0
lisavanbulin
0
Banques de données
ClinicalTrials.gov
['NCT02895360']
Types de publication
Clinical Trial, Phase I
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1067-1076Références
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