Phase Ib study of pevonedistat, a NEDD8-activating enzyme inhibitor, in combination with docetaxel, carboplatin and paclitaxel, or gemcitabine, in patients with advanced solid tumors.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ pharmacokinetics
Carboplatin
/ administration & dosage
Cohort Studies
Cyclopentanes
/ administration & dosage
Deoxycytidine
/ administration & dosage
Docetaxel
/ administration & dosage
Female
Follow-Up Studies
Humans
Male
Maximum Tolerated Dose
Middle Aged
NEDD8 Protein
/ antagonists & inhibitors
Neoplasms
/ drug therapy
Paclitaxel
/ administration & dosage
Prognosis
Pyrimidines
/ administration & dosage
Tissue Distribution
Young Adult
Gemcitabine
Advanced solid tumors
Clinical research
Pevonedistat
Phase Ib study
Standard-of-care chemotherapies
Journal
Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330
Informations de publication
Date de publication:
02 2019
02 2019
Historique:
received:
01
03
2018
accepted:
11
05
2018
pubmed:
22
5
2018
medline:
22
1
2020
entrez:
22
5
2018
Statut:
ppublish
Résumé
Purpose This phase Ib study (NCT01862328) evaluated the maximum tolerated dose (MTD), safety, and efficacy of pevonedistat in combination with standard-of-care chemotherapies in patients with solid tumors. Methods Patients received pevonedistat with docetaxel (arm 1, n = 22), carboplatin plus paclitaxel (arm 2, n = 26), or gemcitabine (arm 3, n = 10) in 21-days (arms 1 and 2) or 28-days (arm 3) cycles. A lead-in cohort (arm 2a, n = 6) determined the arm 2 carboplatin dose. Dose escalation proceeded via continual modified reassessment. Results Pevonedistat MTD was 25 mg/m
Identifiants
pubmed: 29781056
doi: 10.1007/s10637-018-0610-0
pii: 10.1007/s10637-018-0610-0
pmc: PMC6510847
doi:
Substances chimiques
Cyclopentanes
0
NEDD8 Protein
0
NEDD8 protein, human
0
Pyrimidines
0
Deoxycytidine
0W860991D6
Docetaxel
15H5577CQD
Carboplatin
BG3F62OND5
Paclitaxel
P88XT4IS4D
pevonedistat
S3AZD8D215
Gemcitabine
0
Banques de données
ClinicalTrials.gov
['NCT01862328']
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
87-97Références
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