A phase I pharmacokinetic and safety study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) alone and in combination with carboplatin in patients with advanced solid malignancies and biliary tract cancers.
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Biliary Tract Neoplasms
/ drug therapy
Carboplatin
/ adverse effects
Cohort Studies
Female
Humans
Male
Maximum Tolerated Dose
Middle Aged
Nanoparticles
/ administration & dosage
Paclitaxel
/ adverse effects
Treatment Outcome
Biliary tract cancer
Carboplatin
Paclitaxel
Pharmacokinetics
Phase I
Journal
Cancer chemotherapy and pharmacology
ISSN: 1432-0843
Titre abrégé: Cancer Chemother Pharmacol
Pays: Germany
ID NLM: 7806519
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
received:
21
08
2020
accepted:
18
01
2021
pubmed:
27
2
2021
medline:
18
9
2021
entrez:
26
2
2021
Statut:
ppublish
Résumé
Paclitaxel injection concentrate for nano-dispersion (PICN) is a Cremophor-free, nanotechnology-driven paclitaxel formulation. This phase I study examined the safety, tolerability, pharmacokinetics and maximum tolerated dose (MTD) of PICN alone and in combination with carboplatin. Its early efficacy in unresectable biliary tract cancers (BTCs) was also evaluated. This multi-center study comprised two parts. Part A contained a dose-escalation cohort following "3 + 3" design using PICN monotherapy in advanced solid tumors (Part A1); Part A2 dose-expansion cohort was then conducted in advanced BTCs due to observed efficacy in Part A1. Part B1 and B2 evaluated escalating dose of PICN with carboplatin in advanced solid tumors. PICN was administered as a 30 min-infusion every 3 weeks without pre-medications for hypersensitivity reactions. Thirty-six patients received PICN monotherapy in Part A and 21 received PICN plus carboplatin in Part B. The MTD of PICN was determined to be 295 mg/m This study demonstrated the safety and stable pharmacokinetics of PICN as a monotherapy and in combination with carboplatin. Single-agent PICN showed promising antitumor activity in advanced BTCs, warranting further studies to investigate its role in gastrointestinal cancers.
Identifiants
pubmed: 33634324
doi: 10.1007/s00280-021-04235-z
pii: 10.1007/s00280-021-04235-z
doi:
Substances chimiques
Carboplatin
BG3F62OND5
Paclitaxel
P88XT4IS4D
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
779-788Références
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